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Fast tracking informative clinical trials: lessons for mental health

The 5 Principles To Guide The Future Of Randomized Clinical Trials

Enabling "Good" Clinical Research In LMICs With The Good Clinical Trials Collaborative

Paving the Way to Inclusive Communities for Children with Disabilities

The Global Health Network welcomes the highly encouraging news on Pfizer/ Biontech COVID-19 vaccine

Neurodevelopmental milestones and associated behaviours are similar among healthy children across diverse geographical locations

The latest findings from the international INTERGROWTH-21^st Project, that has monitored healthy, urban children from educated families across four continents from early pregnancy to 2 years of age, show that human neurodevelopment is not influenced by the colour of an individual’s skin.

How to Implement Blended Learning: Experiences of the Nigerian faculty

Several of Global Health Trials' Regional Faculties have implemented exceptional, cost-effective blended learning schemes, using a computer room and the Global Health Network's free eLearning courses to create a novel way of building their research teams' skills and knowledge. The Nigerian faculty explain their experiences here, and you can download their "how to" document on the right hand side of the screen, to use at your own site!

Guidelines for the Content of Statistical Analysis Plans in Clinical Trials

While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support transparency and reproducibility. Recommendations are provided for a minimum set of items that should be addressed and included in SAPs for clinical trials. Trial registration, protocols, and statistical analysis plans are critically important in ensuring appropriate reporting of clinical trials.

Development of an online resource for recruitment research in clinical trials to organise and map current literature

Transparency in the conduct and reporting of clinical trials is supported by the guidance produced on the content of clinical trial protocols and reporting standards for clinical trials. While the principle features of the statistical analysis are required within this guidance it is generally accepted that a separate Statistical Analysis Plan is also developed as the level of detail appropriate for a SAP is excessive for a protocol. However, there is no detailed guidance on the content of a SAP and consequently, there is marked variation in practice. 

A Guide to Efficient Trial Management

This Guide to Efficient Trial Management, published by the Trial Manager's Network (UK) and available freely online, is a must for all trial managers or coordinators. This link is for the 6th Edition (2018)

Pragmatism in practice: lessons learned during screening and enrollment for a randomised controlled trial in rural northern Ethiopia

We use the example of the Gojjam Lymphoedema Best Practice Trial (GoLBeT), a pragmatic trial in a remote rural setting in northern Ethiopia, to extract lessons relevant to other investigators balancing the demands of practicality and community acceptability with internal and external validity in clinical trials.

Participant-level data and the new frontier in trial transparency

We have to learn as much as we can about the benefits, risks, costs, and appropriate role of disclosing participant-level data, in service to the ultimate goal of honoring each trial volunteer's altruism.

Access to regulatory data from the European Medicines Agency: the times they are a-changing

a milestone for data transparency in clinical research is within reach- it is hoped this is not unnecessarily delayed.

Sharing research data to improve public health

Mark Walport and Paul Brest argues that we need to ensure that research outputs are used to maximise knowledge and potential health benefits

Whose data set is it anyway? Sharing raw data from randomized trials

In this paper, Andrew Vickers argues that attitudes towards data sharing in the clinical trial community need to rethought, drastically

A systematic review of barriers to data sharing in public health

This study looks at the challneges of data sharing globally. 

Secure use of individual patient data from clinical trials

Publishing the results of all clinical trials, whoever funds them, is required for ethical, scientific, economic, and societal reasons

Prepublication data sharing

Rapid release of prepublication data has served the field of genomics well. Attendees at a workshop in Toronto recommend extending the practice to other biological data sets.

Sharing health data: developing country perspectives

Sharing data is not only about the technical dimension such as data management, repositories and libraries; developing countries are concerned about factors that impede data sharing, in particular, fairness

Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data

Comparing potential commercial interests with seven specifications of relevant public interest reveals the lack of proportionality inherent in the current practices of EMA and NICE.

The double-edged sword of open access to research data

John A. Spertus suggests that there needs to be some consideration about the practicalities of data sharing- in how it is shared, investment, and ensuring that data are appropriately analyzed 

The delay in sharing research data is costing lives

This article argues that scientists need to feel greater urgency to share their findings quickly, and they need additional avenues to facilitate this process.

Clinical trial transparency and orphan drug development: recent trends in data sharing by the pharmaceutical industry

This paper summarises major developments in clinical trial transparency between January and June 2013 and analyses the composition of datasets released by GlaxoSmithKline.

Increasing the accessibility of data

This article looks at the benefits of data sharing, and argues for increasing the accessibility of data

Introduction: data sharing and disclosure limitation techniques

This article details the procedures and requirements for researchers in sharing data from clinical trials. 

Characteristics desired in clinical data warehouse for biomedical research

This article proposes some key characteristics needed in a clinical data warehouses for biomedical research

Sharing research data to improve public health: a perspective from the global south

This article asks the question: how do we achieve fair trade in the sharing of clinical data?

The International Stroke Trial database

We aimed to make individual patient data from the International Stroke Trial (IST),  available for public use, to facilitate the planning of future trials and to permit additional secondary analyses.

Ushering in a new era of open science through data sharing: the wall must come down

This article argues against selective publication and for a clear view of the totality of evidence relevant to many research questions and clinical decisions.

Promoting transparency in pharmaceutical industry-sponsored research

Policies that promote transparency in the clinical trial research process, through improved and expanded disclosure of investigator contributions and funding, comprehensive publicly available trial registration, and independent analysis of clinical trial data analysis may address these subversive practices by improving accountability among industry and investigators.

Clinical trial data as a public good

Lack of access to detailed information about clinical trials can undermine the integrity of medical knowledge.

Data sharing in medical research: an empirical investigation

This study looks at the sharing of data between researchers; it details concerns about speed of reply, and highlights an unfortunate situation where researchers are more concerned with losing an advantage than advancing science.

Sharing of clinical trial data among trialists: a cross sectional survey

This article investigate clinical trialists’ opinions and experiences of sharing of clinical trial data with investigators who are not directly collaborating with the research team.

Improving health research governance and management in the Western Pacific: A WHO Expert Consultation

WHO organised an expert consultation on research in the Western Pacific

A mechanism for controlled access to GWAS data: experience of the GAIN Data Access Committee

This article looks at how access to GAIN information has furthered advances in he understanding of the genetic underpinnings of mental-health disorders, diabetes, and psoriasis.

Drug watchdog ponders how to open clinical trial data vault

EMA is discussing how to shape the new policy with academics, patient organizations, and drug companies; their final advice is due by the end of next month.

Towards a data sharing culture: recommendations for leadership from academic health centers

Heather A Piwowar proposes that AHCs can and should lead the transition towards a culture of biomedical data sharing.

Withholding access to research data - Authors' reply

The Lancet suggests that transparency in science will increase public trust and reduce the deliberate manipulation of data to score political, financial, or ideological points.

Time for fair trade in research data

  This argues for all the positives of data sharing

Sharing health data: good intentions are not enough

In this round table paper, we suggest goals for data sharing and a work plan for reaching them, and challenge respondents to move beyond well intentioned but largely aspirational data sharing plans.

Data sharing: not as simple as it seems

This article argues that it is inappropriate to prescribe exactly when or how researchers should preserve and share data.

Ethical data release in genome-wide association studies in developing countries

This article looks at the ethical problems involved in data sharing within the Genome-Wide Association Studies in Developing Countries

Access to patient-level data from GlaxoSmithKline clinical trials. New England Journal of Medicine

GSK reccently trailed the sharing of deidentified patient-level data. This article describes the approach adopted and answers some of the most common questions received

Preparing for responsible sharing of clinical trial data.

This article argues that expanded data sharing must be pursued thoughtfully.  

Systematic archiving and access to health research data: rationale, current status and way forward.

This paper discusses important developments in data-sharing policy and highlights factors in health research that may affect policy implementation

Sharing data for public health: where is the vision?

This article argues that WHO need to take leadership of the data sharing debate

Is there a duty to share? Ethics of sharing research data in the context of public health emergencies

This article explores the foundation and nature of a duty, if any, that researchers have to share data, specifically in the context of public health emergencies. 

Drug firms take legal steps to prevent European regulator releasing data

A leading US pharmaceutical company, AbbVie, has taken legal action against Europe’s medicines regulator to try to prevent it from releasing data it holds on the safety and efficacy of one of its drugs.

Preparing individual patient data from clinical trials for sharing: The GlaxoSmithKline approach

This article describes how to prepare data for sharing with other researchers in a way that minimises risk with respect to the privacy and confidentiality of research participants. 

Towards agreement on best practice for publishing raw clinical trial data

This article aims to address inadequate reporting in randomised controlled trials.

Project data sphere to make cancer clinical trial data publicly available.

After a global push, cancer clinical trial data is to be shared. 

Sharing of research data

Geoffrey Boulton lays out the case for sharing scientific data, and advises that the UK's Royal Society has established a working group to examine the implementation issues and to make recommendations.

Full access to trial data holds many benefits and a few pitfalls, conference hears

The BMJ Group and the Association of the British Pharmaceutical Industry conference discusses the dangers and promises of trial data 

Time to mandate data release and independent audits for all clinical trials

Medical journals should insist on the release of all raw data and a written independent clinical audit.

Strengthening and opening up health research by sharing our raw data

Peter C. Gøtzsche's speech on the moral obligation and societal benefits of providing free access to all anonymized raw patient data from clinical research

Why we need easy access to all data from all clinical trials and how to accomplish it

Gøtzsche argues that the distinction between publicly-funded and industry-funded research is an artificial and irrelevant one, as the interests of the patients must override commercial interests

We need access to all data from all clinical trials.

Peter Gøtzsche argues why it is a moral imperative to render all results from all trials involving humans, also healthy volunteers, publicly available

The new BMJ policy on sharing data from drug and device trials

The BMj's new policy is a necessary first step towards the full sharing of all anonymised trial data

Limited access data sets from studies funded by the National Heart, Lung, and Blood Institute

This paper describes this policy as well as the limited access data sets currently available from NHLBI.

Redefining genomic privacy: trust and empowerment

This article suggests the use of trust-enabling techniques to create a solution in which researchers and participants both win with data sharing.

Routes for breaching and protecting genetic privacy

This article presents an overview of genetic privacy breaching strategies, and reviews potential mitigation methods for privacy-preserving dissemination of sensitive data and highlight different cases that are relevant to genetic applications.

Access to patient-level trial data--a boon to drug developers

The EMA argues that access to full — though appropriately deidentified — data sets from clinical trials will benefit the research-based biopharmaceutical industry.

Respectful re-use

The impact of the papers we publish depends increasingly on the data they describe. In insisting on data access for referees and readers, we prioritize scientific integrity above all and place the interests of research participants before impact.

Data sharing will pay dividends

As public pressure builds for drug companies to make more results available from clinical trials, the industry should not forget that it relies on collective goodwill to test new therapies.

Towards an Ethics Safe Harbour for Global Breast Cancer Research. Current Oncology

This article proposes a ‘Safe Harbor Framework for International Ethics Equivalency’ that facilitates the harmonization of ethics review of specific types of data-driven international research projects while respecting globally transposable research ethics norms and principles

Transparency interrupted: the curtailment of the European Medicines Agency's Policy on access to documents.

Peter Doshi looks at the curtailment of EMA’s policy on access to documents, which is rgues is a major step backward for the transparency of clinical trials and for public health.

Part III: Meeting the Challenge When Data Sharing Is Required

The article describes several approaches that can be used in meeting the challenges posed by the sharing of confidential data.

Part II: HIPAA and Disclosure Risk Issues

This guide looks at whether deidentification is sufficient in data sharing. 

Part I: What Is the Requirement for Data Sharing?

This article looks at rules and regulations for data sharing. 

Sharing individual level data from observational studies and clinical trials: a perspective from NHLBI

The National Heart, Lung, and Blood Institute (NHLBI) has developed a data-sharing protocol focused on balancing the interests of study participants, study investigators, and the research community with independent oversight by the NHLBI IRB.

Editorial: Research data ownership and dissemination: is it too simple to suggest that 'possession is nine-tenths of the law

This article argues that ownership of research data is a complex issue and warrents cafeful examination. 

A review of the barriers to sharing in biobanking

This article provides a description of the barriers to sharing in biobanking, discusses key themes, and concludes that empirical research is required to determine the full extent of the challenges addressed in the literature.

Increasing value and reducing waste: addressing inaccessible research

This article looks at the problems caused by inaccessible data to journal reporting, finance and funding; it then looks at possible solutions. 

Pediatric data sharing in genomic research: attitudes and preferences of parents

The current study examines genomic research participants' attitudes to explore differences in data sharing preferences between parents of pediatric patients and adult patients.

Withholding access to research data

Elizabeth Pisani and colleagues highlight obstacles to data sharing in public health. However, they omit a potentially crucial one: investigators manipulating evidence that might contradict their hypotheses or conclusions.

Data sharing in research: benefits and risks for clinicians

Elliot Antman explore issues surrounding data sharing in scientific research

Data sharing for pharmacokinetic studies

This article looks at the problems of data sharing in clinical trials, data ownership and development of databases to enable safe sharing processes. 

CDISC | Strength Through Collaboration

Collaboration which allows protocol build, data collection and data sharing via free and open access web support.  

Strengthening Research through Data Sharing

Elizabeth Warren addresses the policy, privacy, and practical issues affecting data sharing in clinical trails. 

A Global, Neutral Platform for Sharing Trial Data

Brigham and Women's Hospital–Harvard University's Multi-Regional Clinical Trials Center is designing a platform to link existing data-sharing platforms and communities and host data from investigators who want to share data but lack the resources to do so.

From Patient to Patient — Sharing the Data from Clinical Trials

This article asks the question: how — and how much — to share, where and in what format data should be stored and accessed, and how to protect the privacy of the trial participants.

Data sharing guidance for CRUK researchers initiatives and repositories to support clinical rseacrhers with data management and sharing contents

Cancer Research UK highlights some key initiatives and repositories which may provide tools and guidance for data sharing in the academic clinical trial field.

Research Data Management and Sharing

The University of Carolina offers a free eLearning course about data management and sharing.

The ethics of 'Trials within Cohorts' (TWiCs) 2nd international symposium

The two-day symposium enabled an international group to meet and share experiences of the TwiCs design and to discuss plans for future research.

Research Data Oxford » Data management planning

The University of Oxford's tips for data management planning.

Association for Clinical Data Management: Training

The ACDM represents professionals working in the management of clinical data

Open Access Policy Frequently Asked Questions - Bill & Melinda Gates Foundation

The Bill and Melinda Gates foundation answers questions about their open access policy. 

Data sharing statements for clinical trials

The ICMJE introduces it's vsion for a global research community in which sharing deidentified data becomes the norm.

A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials.gov: findings from a review of randomised controlled trials of rheumatoid arthritis

This study assess the uptake of the rheumatoid arthritis core outcome set using a new assessment method of calculating uptake from data in clinical trial registry entries.

Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials (Version 1) GOOD PRACTICE PRINCIPLES FOR SHARING INDIVIDUAL PARTICIPANT DATA FROM PUBLICLY FUNDED

Thid guide offers good practice principles for sharing data from clinical trails

Section 2 Guidelines and standards A Planning and conducting MRC-funded research

Guidelines for MRC research and management of data. 

Pharmaceutical companies' policies on access to trial data, results, and methods: audit study

This study looks at the commitments made by companies to transparency of trials.

Making research data repositories visible: The re3data.org registry

This article describes the heterogeneous RDR landscape. Further, the article outlines the features of re3data.org, and shows how this registry helps to identify appropriate repositories for storage and search of research data.    

Raw data from clinical trials: Within reach?

This article argues in favor of more widespread availability of data from clinical research.

Are Scientific Data Repositories Coping with Research Data Publishing?

This study analyses the solutions offered by generalist scientific data repositories.

The Yale Open Data Access (YODA) Project — A Mechanism for Data Sharing

The Yale Open Data Access (YODA) Project is one of several pioneering data-sharing models in use. It uses a “trusted intermediary” approach, in which an independent partner provides support, accountability, fairness, and transparency.

Trust, Respect, and Reciprocity: Informing Culturally Appropriate Data-Sharing Practice in Vietnam

This study used in-depth interviews and focus group discussions with 48 stakeholders in Vietnam to explore the experiences, attitudes, and expectations that inform ethical and effective approaches to sharing clinical research data.

Sharing Data from Cardiovascular Clinical Trials — A Proposal

ACCESS CV proposes a secure method of sharing sensitive patient data that balances the legitimate desire of the scientific community for data access with the responsibility to ensure high-quality analyses and protection of patients’ expectation of privacy.

Bridging the Data-Sharing Divide — Seeing the Devil in the Details, Not the Other Camp

Lisa Rosenbaum looks at both sides of the data sharing discussion. 

Avoiding Data Dumpsters — Toward Equitable and Useful Data Sharing

Although some researchers remain wary about sharing data, recent policies and proposals mean that data sharing, in one form or another, is inevitable.

Incentives for Clinical Trialists to Share Data

Sharing of data from clinical trials benefits patients by enabling new discoveries, meta-analyses, and confirmation of published results.

Sharing Clinical Trial Data: A Proposal from the International Committee of Medical Journal Editors

The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials.

A systematic review of motivational interviewing for weight loss among adults in primary care

Motivational interviewing (MI) is a client-centred method of intervention focused on enhancing intrinsic motivation and behaviour change. This article looks at MI in adults in primary care. 

Effectiveness of a motivational interviewing intervention on weight loss, physical activity and cardiovascular disease risk factors: a randomised controlled trial with a 12-month post-intervention fol

This is the first study to document the longer-term effects of adapted motivational interviewing, delivered in the primary care setting, on BMI, physical activity and related CVD risk factors.

Empirical study of data sharing by authors publishing in PLoS journals

This study determines how well authors comply with data sharing policies in Clinical Research Trails. 

Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers

Iain Hrynaszkiewicz and colleagues propose a minimum standard for de-identifying datasets to ensure patient privacy when sharing clinical research data.

The importance of clinical trial data sharing: toward more open science

The double-edged sword of open access to research data. 

Sharing Clinical Research Data City: Washington, D.C. Publisher: National Academies Press

This e-book covers benefits, barriers and models for data sharing. 

Data Sharing at a Crossroads

The clinical research community is at an important crossroads about sharing data. 

BioSharing: curated and crowd-sourced metadata standards, databases and data policies in the life sciences

BioSharing harnesses community curation to collate and cross-reference resources across the life sciences from around the world. 

Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors

The ICMJ gives its vision for a global research community in which sharing de-identified data becomes the norm.

Blockchains for Data Sharing in Clinical Research: Trust in a Trustless World

Data sharing is now a major theme in clinical research. However, effective, ethical sharing of clinical research data requires trust: research subjects must trust investigators to preserve their privacy, investigators must trust each other to give credit where credit is due, and the integrity of the entire research enterprise must be trusted by all. 

Data Sharing; Transparency Initiative - The Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital

The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT) aims to improve the integrity, safety, and rigor of global clinical trials.

Clinical Trial Data Sharing

Barbara Bierer presents changes in data sharing, and gives solutions to challenges facing the feild. 

The Project Data Sphere Initiative: Accelerating Cancer Research by Sharing Data

Access to large, late-phase, cancer-trial data sets has the potential to transform cancer research by optimizing research efficiency and accelerating progress toward meaningful improvements in cancer care.

A SOA-Based Platform to Support Clinical Data Sharing

This article looks at the development of software to enhance the integration between patient-care practice and medical research.

Feasibility, Process, and Outcomes of Cardiovascular Clinical Trial Data Sharing

Data sharing is as an expanding initiative for enhancing trust in the clinical research enterprise

Introduction to Research Electronic Data Capture (REDCap) and REDCap2SDTM, a Conversion Tool to Facilitate Clinical Research Data Sharing

A new tool for the capture and conversion of clinical data is introduced as a way to encourage reuse of data and to reduce workloads in new studies. 

Data sharing through an NIH central database repository: a cross-sectional survey of BioLINCC users

This article assesses the use of the BioLINCC by clinical researchers. 

Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis

This article looks at how data sharing could change and challenge design, conduct, and reporting of systematic reviews and meta-analyses for Clinical Research, as well as it's impact on those involved in evidence synthesis. 

Data sharing and the evolving role of statisticians

Statisticians are ambassadors for data sharing and are central to its success; this article looks at how the role is changing with new technologies and trends for data transparency. 

Data Sharing

The article poses the question: How would data sharing work best?

Development of an open-source, flexible framework for complex inter-institutional disparate data sharing and collaboration

The devolpment of a data sharing database makes it easier to harmonize and manage for data mining.

Technical and policy approaches to balancing patient privacy and data sharing in clinical and translational research.

In this paper, we review several aspects of the privacy-related problems associated with data sharing for clinical research from technical and policy perspectives.

Open Science and Data sharing in Clinical research: Basing Informed Decisions on the Totality of Evidence

Basing Informed Decisions on the Totality of the Evidence

Application Description and Policy Model in Collaborative Environment for Sharing of Information on Epidemiological and Clinical Research Data Sets

This article describes a web appliaction for data sharing for clinical research. 

Biomedical Data Sharing and Reuse: Attitudes and Practices of Clinical and Scientific Research Staff

This study investigates these differences in experiences with and perceptions about sharing data, as well as barriers to sharing among clinical and basic science researchers.

The Changing Structure of Industry-Sponsored Clinical Research: Pioneering Data Sharing and Transparency

This article looks at the thriving interest in open science and the inevitable widespread adoption of data, and how the two can be managed. 

Approaches and Costs for Sharing Clinical Research Data

This article looks at the complex issues behind data sharing in clinical trials. 

Sharing clinical research data in the United States under the health insurance portability and accountability act and the privacy rule

This article looks at the interaction in the USA between sharing data from clinical trails and the Privacy Rule adopted under the Health Insurance Portability and Accountability Act.

Sharing Privacy Protected and Statistically Sound Clinical Research Data Using Outsourced Data Storage

This article proposes a controlled secure aggregation protocol to secure both privacy and accuracy when researchers outsource their clinical research data for sharing

DICOM for quantitative imaging biomarker development: a standards based approach to sharing clinical data and structured PET/CT analysis results in head and neck cancer research

Article on the devolpment of Imaging biomarkers and the need for data sharing for this. 

IMPACT Observatory: tracking the evolution of clinical trial data sharing and research integrity

The objective of this paper is to present the IMPACT Observatory as well as share some of its preliminary findings

Statistical controversies in clinical research: data access and sharing—can we be more transparent about clinical research? Let’s do what’s right for patients

The question at the center of the open-science efforts for clinical trials should not be whether data should be shared, but rather how we can usher in responsible methods for doing so.

Emerging molecular markers for the prognosis of differentiated thyroid cancer patients

A review into new molecular markers potentially able to ameliorate the prognosis in thyriod cancer patients.

Sharing of clinical trial data and research integrity

An article arguing that full transparency of clinical trial data is an essential prerequisite to achieving research integrity. 

Data Sharing Policy

The Medical Research Council's policy on data sharing.

Best Practices for Ethical Sharing of Individual-Level Health Research Data From Low- and Middle-Income Settings

This article discusses the results of a systematic review and multisite qualitative study of key stakeholders’ perspectives on best practices in ethical data sharing in low- and middle-income settings.

Sharing Individual-Level Health Research Data: Experiences, Challenges and a Research Agenda

In this paper, we share our experiences establishing data management systems and data-sharing infrastructure including a data-sharing policy, data access committee and related procedures.

Views of Ethical Best Practices in Sharing Individual-Level Data From Medical and Public Health Research

This scoping review of empirical research and conceptual literature examined stakeholders’ perspectives of ethical best practices in data sharing, particularly in low- and middle-income settings.

Data Sharing and the Journal

The Journal seeks to show it's commitment to data sharing in the setting of clinical trials.

Sharing Individual Participant Data from Clinical Trials: An Opinion Survey Regarding the Establishment of a Central Repository

An article looking at the major issues facing access to, and sharing of, Individual Participant Data.

Developing Ethical Practices for Public Health Research Data Sharing in South Africa

Amid increasing calls for more effective sharing of individual-level data, commitment to promote access to research data is evident within South Africa’s public research sector, but national guidance and regulation are absent.

Are clinical trial data shared sufficiently today? No

A useful editorial by Ben Goldacre reviewing the current status of data sharing in clinical trials’

Wellcome and Open Research

The TDR Global Competency Framework for Clinical Research: a set of tools to help develop clinical researchers

The TDR Global Competency Framework for Clinical Research is a flexible framework which lists all the competencies that should be demonstrated by a research team to carry out a successful clinical study. It can be used for any research study, regardless of the size of the team and of the study itself. It can help to plan the staffing requirements for a study, to help carry out appraisals of staff, to help individuals plan their career development, and to help to develop educational curricula for research staff. 

Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia

This study highlights the utility of rapid ethical assessment prior to clinical trials involving complex procedures and concepts.

Planning, Monitoring and Evaluation: Framework for Research Capacity Strengthening

This framework describes key components of capacity development, indicators for their success and ways to verify capacity development.

Comprehensive Public Health Degree Guide

Public Health Degrees.org is a comprehensive search engine designed for students who are interested in learning more about Public Health and Health Sciences programs around the United States.

Sponsorship in non-commercial clinical trials

Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period.

eSeminar: Research papers that make a difference: discussing research waste, reproducibility and impact

Dr Iveta Seimer, Deputy Director of the UK EQUATOR Centre, discusses research waste, reproducibility, and how to use reporting guidelines to make an impact. Poor reporting seriously affects the integrity of health research literature and critically limits the use and impact of published studies.

New INTERGROWTH-21st International Postnatal Growth Standards for Preterm Infants - Charts available

New INTERGROWTH-21st Postnatal Growth Standards charts for individual measurements of length, weight, head circumference, as well as a combined standards chart for length, weight and head circumference are now available for download here.

Using the CONSORT for Abstract Checklist

The CONSORT (CONsolidated Standards of Reporting Trials) 2010 guideline is intended to improve the reporting of parallel-group randomized controlled trial (RCT), enabling readers to understand a trial's design, conduct, analysis and interpretation, and to assess the validity of its results. This can only be achieved through complete adherence and transparency by authors. This series explores how an abstract can be improved through use of the CONSORT guidelines.

Postnatal growth standards for preterm infants: the Preterm Postnatal Follow-up Study of the INTERGROWTH-21st Project

The first international stnadards for monitroing the growth of preterm babies have now been published in the Lancet Global Health (October 2015). 

How the use of rapid diagnostic tests influences clinicians’ decision to prescribe ACTs

Evidence shows that in many African regions, including Ghana, malaria is massively over-diagnosed. This means that patients who are not diagnosed with malaria by tests that identify malaria parasites in the blood are still considered to have the disease and therefore receive anti-malarial treatment.

Training manuals from REACT study in Cameroon

Training manuals from REACT study in Cameroon. REACT Cameroon designed six training modules to support the introduction of malaria rapid diagnostic tests (RDTs). The manuals were used to train health workers at government and mission hospitals and health centres. The six modules are presented in two manuals

Cost-effectiveness of interventions to support the introduction of malaria rapid diagnostic tests in Cameroon

Scientific title: A cost-effectiveness analysis of provider interventions to improve health worker practice in providing treatment for uncomplicated malaria in Cameroon. Testing patients before prescribing medication is important, and should ensure patients receive the most appropriate treatment. This is important because unnecessary and inappropriate treatment has costs –incurred by patients, but also governments and donors working to control malaria.

TACT Training Manuals for Malaria Rapid Diagnostic Tests (RDTs)

The TACT training manuals and patient leaflet were designed to support the use of malaria rapid diagnostic tests (RDTs). Here we provide Trainer/Trainee manuals in English and French, and visual patient information sheets in English, French and Swahili. 

A Guide to Grant Writing (available in English and Spanish)

Grant applications differ substantially depending on the individual funding organisation, and each funding organisation has its own organisational aims, which are important to understand when you are considering which grant to apply to. In this article we provide practical tips and information for writing grant applications, which can be applied to grant applications of all sorts, from fellowships to large funding applications.

INTERGROWTH-21st Fetal Growth Standards

Fetal Growth Standards for ultrasound measurements of head circumference (HC), bi-parietal diameter (BPD), occipito-frontal diameter (OFD), femur length (FL) and abdominal circumference (AC) are now available for download. For information about how to perform these measurements, or for other information on standards in ultrasound imaging, please see the ultrasound training toolkit.

Clinical Research Careers: an Indian Perspective

Shared panel discussion conducted about clinical research careers in India (conducted in Telugu and English), and article about research careers in India from Sreedhar Tirunagari

How to prepare for a job interview and predict the questions you’ll be asked

Job interviews can be intimidating, but simply preparing well can make the difference between succeeding or failing, regardless of how nervous you are. In this article we pull together advice on how to prepare for job interviews and how to know what questions you’ll be asked. 

Q&A with Professor Trudie Lang: Why Global Health Trials?

In celebration of Global Health Trials' fifth birthday (May 11th 2015) Professor Trudie Lang, Principal Investigator of the programme, talks to us about why Global Health Trials was started, why people should share their experience, and what the future holds.

Strengthening capacity to apply health research evidence in policy making: experience from four countries

Little experience of strengthening the capacity of policy makers in low- and middle- income countries has been published to date. This article describe the experiences of five projects (in Bangladesh, Gambia, India and Nigeria) - author available to comment!

Notes on How to Survive a GCP Audit forum discussion based on the GCP Inspection Course (Global Health Network eLearning course)

Commentary on the Introduction to Data Management Course

ABRAID – The Atlas of Baseline Risk Assessment for Infectious Diseases - Call for feedback

ABRAID, new website of infectious diseases risk maps 

SPIRIT guidelines for Protocol Writing

Links to the SPIRIT guidelines for protocol development and information about these guidelines - all free and open access.

INTERGROWTH-21st Newborn Size at Birth Chart

Practical chart for health practitioners to use to assess newborn size (weight, length, head circumference) at birth against global standards. This version of the chart is being piloted within the University of Oxford hospital network, and plans to pilot in the INTERGROWTH-21st study sites and in Boston area hospitals are developing quickly. Practitioners can download and use this version of the chart freely. To connect with the INTERGROWTH-21st team regarding your experience with piloting this chart, or to request modifications to the chart (e.g. language; different institutional logo), please contact intergrowth21st@tghn.org.  

Research Administration and Grant Management

Links to resources provided by iRIM (the Initiative on Research and Innovation Management) - free online presentations and tutorials relating to how to manage grants and perform administration of clinical research projects effectively.

Managing clinical trials

Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field.

International Women's Day: Women in Science

Discussing the study protocol part 2

South African Faculty Workshop: Clinical Trial Site Management

On the 19th September 2014, Global Health Trials Southern Africa held its Annual Faculty Meeting, themed Clinical Trial Site Project Management. You can download the presentations from the talk and leave feedback here.

Blood Pressure Measurement Protocol

This protocol outlines the technique for taking a pregnant woman's blood pressure. http://www.medscinet.net/Intergrowth/patientinfodocs/BP%20protocol.pdf

Correct Measurement of Fetal Crown Rump Length and Standardization of Ultrasonographers

The aim of this manual is to ensure all trained ultrasonographers are familiar with the standardized way crown-rump length measurements should be taken for the purposes of using the INTERGROWTH-21^st fetal growth standards. http://www.medscinet.net/Intergrowth/patientinfodocs/CRLstandardisation_Website.pdf

Sleep-Wake Cycle Assessment Manual

This manual details the technique for assessing sleep-wake cycles in children. http://www.medscinet.net/Intergrowth/patientinfodocs/Sleep-wake%20cycle%20assessment%20manual%20July%202014.pdf

Five keys to improving research costing in low- and middle-income countries

ESSENCE on Health Research have created a good practice document on research costing. It includes a review of the funding practices related to the definition and funding of direct and indirect costs. 

Monitoring - A Gradual Process

New to monitoring clinical research trials? Ogundokun Olusegun outlines some of the responsibilities and tasks that the role involves, from revieiwing sites and managing research centers to the lifestyle pressures on the road.

A template for writing a research protocol

PRISMA for Abstracts: Reporting Systematic Reviews in Journal and Conference Abstracts

Despite published guidance on writing the abstract in the PRISMA Statement guiding the reporting of systematic reviews in general and elsewhere, evaluations show that reporting of systematic reviews in journal and conference abstracts is poor. Teh authors developed consensus-based reporting guidelines as an extension to the PRISMA Statement on good reporting of systematic reviews and meta-analyses in abstracts.

Data Management Overview - Coding and Guidelines

Powerpoint slides representing a comprehensive overview of some issues surrounding data management, including an overview of data management, the issue of coding, and regulations and guidelines.     NEW ADDITIONS AUGUST 2013: Code of Federal Regulations part 11 - Guidelines on how to implement

Research Misconduct in Low- and Middle-Income Countries.

Research misconduct is a global problem as research is a global activity. Wherever there is human activity there is misconduct, but we lack reliable data on the extent and distribution of research misconduct. This PLoS paper seeks to illustrate some examples of researsch misconduct in LMICs.

5 ways statistics can fool you—Tips for practicing clinicians

In this article, the authors illustrate five basic statistical concepts that can significantly impact the interpretation of the medical literature and its application to the care of patients, drawing examples from the vaccine literature: (i) consider clinical and statistical significance separately, (ii) evaluate absolute risks rather than relative risks, (iii) examine confidence intervals rather than p values, (iv) use caution when considering isolated significant p values in the setting of multiple testing, and (v) keep in mind that statistically nonsignificant results may not exclude clinically important benefits or harms.

GCP-compliant data management in multinational clinical trials.

Transnational Working Group on Data management of the ECRIN, the European Clinical Research Infrastructures Network, present recommendations for quality and harmonisation for data management. In addition good data management practices in general are identified.

Clinical Data Management: Current status, challenges and future directions from industry perspectives.

Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?

This publication discsusses whether or not open-source clinical trial data management will improve the likelihood that good clinical trials are conducted in resource-constrained settings.

Challenges of non-commercial multi-centre North-South collaborative clinical trials

The last decade has witnessed a substantial increase of multi-centre, public health-oriented clinical trials in poor countries. However, non-commercial research groups have less staff and financial resources than traditional commercial sponsors, so the trial teams have to be creative to comply with Good Clinical Practices (GCP) requirements. This article hopes to feed the reflection on the methodological and ethical aspects of clinical trials carried out in developing countries by North-South collaborative research groups.

Reviewing Clinical Trials: A Guide For The Ethics Committee

This guidance article aims to provide a fully comprehensive, pragmatic guide for researchers of all roles, but especially ethics reviewers, to explain the details of each type of ethics review. The article is available in English, Spanish, Portuguese and Chinese, and has been kindly provided by www.ctmagnifier.org.

Research Reporting Criteria

Research reporting guidelines are standard statements that provide guidance on how to report research methodology and findings. These are in the form of checklists, flow diagrams or texts. Most of the biomedical journals require authors to comply with these guidelines. Guidelines are available for reporting various study designs:

• CONSORT Statement (reporting of randomized controlled trials)
• STARD (reporting of diagnostic accuracy studies)
• STROBE (reporting of observational studies in epidemiology)
• PRISMA (reporting of systematic reviews)
• MOOSE (reporting of meta-analyses of observational studies)

Assessing the quality of informed consent in a resource-limited setting: A cross-sectional study

The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University.

Downloadable Templates and Tools for Clinical Research

A range of downloadable templates and tools for Clinical Research, including monitoring checklists, budget spreadsheets, informed consent forms, SOPs and so on.

Cluster Randomised Trials: A primer

This article is an introduction to cluster randomised trials.

Towards a more pragmatic approach to trial regulation

Clinical trial ethics in India: One step forward, two steps back

Clinical trials in India continue to be in the news, unfortunately a fair bit being negative coverage.

Consent and Community Engagement – A Bibliography in Progress

This bibliography is a work in progress and is regularly revised. We are currently updating it to link to any listed papers that are available via open access. If there are papers we're missing, or if you have other comments, please let us know by writing to info@globalhealthbioethics.org.

Physician-researchers’ experiences of the consent process in the socio-cultural context of a developing country

This paper draws on empirical data obtained from interviews with physician-researchers in teaching hospitals of Lahore, Pakistan. The data identify social and cultural factors that affect the consent process for participants in research.

Ensuring Consent to Research is Voluntary: How Far Do We Need to Go?

One fundamental ethical principle underpinning research ethics is that of respect for persons. It requires that researchers respect research participants’ autonomy, interests, and wishes, and act on the presumption that participants are the best judges of what their interests are (Nuffield Council on Bioethics 2002). This presumption obliges us to design consent processes for research that facilitate prospective participants’ free and informed decisions as to whether or not to participate in a study.

Data Management - an overview

This article explains the process of data management operations within clinical trials from start to finish.

The Draft Statement/Guidelines for Disaster Research

These guidelines were developed following a Working Group on Disaster Research and Ethics (WGDRE) meeting in 2007 with the aim of developing ethical guidelines which would be applicable to post-disaster research, partiuclarly that performed in the developing world. We welcome any feedback from members.

Report from Workshop on Consent and Community Engagment in Health Research: Reviewing and Developing Research and Practice, Kilifi, Kenya Monday 28th February – Thursday 3rd March, 2011

This is the Report from the "Consent to and Community Engagement in Health Research" workshop, which took place between 28 Feb - 03 Mar 2011 in Kilifi, Kenya. The workshop built upon an emerging collaboration between the Ethox Centre in Oxford, the Social and Behavioural Research Group at the Wellcome-KEMRI Unit in Kilifi, the Liverpool School of Tropical Medicine and the Mahidol - Oxford Tropical Medicine Research Unit in Thailand.

Back Translation for Clinical Trial Documentation - Informed Consent Forms

It is a recommendation of some IRB/ECs that back translation is included as a necessary step for the translation of some clinical trial documentation, including informed consent documents. This article explains the reasons for back translation, and takes you through how to effectively perform this step, including explaining how to find a suitable translator for the task.

Templates from an investigator-led trial in Cameroon: the CAMPS trial (also available in French)

During the setting up of our trial in Cameroon we met several operational issues that we needed to overcome. For some of these issues we developed some tools and we have made them available here so that other research groups can use them in their clinical trials.

Ethics in global health research

This articles explores some of the ethical issues arising in the context of collaborative global health research networks involving partners in developing and developed countries.

Ethical criteria in clinical research in developing countries: is there a global standard?

This paper, recently published on the Italian Journal of Tropical Medicine(Vol 15, N 1-4, 2010), reports on a debate that took place during the 6thEuropean Conference of Tropical Medicine in 2009, on some topics of greatinterest for GlobalHealthTrials.org: is there a global standard for clinicalresearch? Should standards be adapted in developing countries? How toencourage research while preventing the exploitation of vulnerableindividuals or groups? Five "debate questions" where addressed by ProfessorNick White and by Dr. Lumuli Mbonile, and discussed with the moderator(Raffaella Ravinetto) and the audience.

Health research: the challenges related to ethical review and informed consent in developing countries

An article about a workshop that assessed ethical review and informed consent in vulnerable populations. This article aims to prompt a debate leading to better guiding principles on health research in constrained settings

Comments required on Proposed new Guidelines for Ethical Review Committees

The WHO invite comments on these new guidelines: Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants

Informed Consent Templates

A set of 4 consent templates for clinical trials, interview studies, observation studies and sampling only studies.

Reciprocal Monitoring Scheme Guidance

This article explains how an East Africa Research Group have developed and applied a highly pragmatic an effective monitoring system. This group train research staff to monitor or perform QC on studies and then implement a system of reciprocal monitoring between studies. It is cost effective and works well.

Guidelines for Clinical Trial Registration

An overview on trial registration. Here you can find out why trials need to be registered and what the difference is between all the registries - and how to register your study.

A general introduction to Biomedical Research Ethics

This article was written by a researcher from Sri Lanka and presents a very helpful overview on Biomedical Ethics. This article will be helpful to all levels of research staff and others who might want an accessible overview

An approach to a centralized Clinical Data Management System - A story from Vietnam

An example of a academic research centre resolving the issue of clinical trial data management Peer reviewed by members of the data management expert committee for this programme.

Clinical Trial Management Tool

This tool has been designed to help researchers run randomised controlled trials. This is available in both English and Spanish

Clinical Trial Monitoring

What is the definition of clinical trial monitoring? Who can be a monitor? What are the monitor's roles and responsibilities? Read on for some answers.

Trial Oversight Committtees

An overview of different types of clinical trial oversight committees, including steering committees and data safety monitoring committees.

Disease-specific Guidance

Coming soon! A paper series on clinical trial design for tropical diseases. Read more here and get involved!

Project Management

Project management ensures that the project does not veer off its intended pathway. This begins in planning, all the way through initiation to completion. Read the full article to learn more.

Clinical Trial Governance

Clinical trial governance encompasses sponsorship, contracts, finance, confidentiality, trial insurance and professional indemnity and scientific and ethical review. You can find guidance and template documents relating to all of these topics throughout GlobalHealthTrials.org or you can contribute your own material to help others.

In-House Monitoring

Reciprocal or in-house monitoring schemes could be an alternative to expensive out-sourcing. Read on to find out more.

Initiating the Trial

The site initiation process is important as it ensures that all the logistics are organised and the site is ready to begin recruiting subjects.

What is a Clinical Trial?

What is the definition of a clinical trial? Is there an international consensus? Read on to find out.

Budget planning and applying for funding

Clinical trials don't have to be expensive! Here are some tips for finding funding and drafting a realistic budget for your study.

Community Engagement

Community sensitisation is a fundamental aspect of clinical trial operations anywhere in the world but is of particular relevance in the developing world. Share your experiences with other developing country researchers.

Data Management

Good data management practices are essential to the success of a trial because they help to ensure that the data collected is complete and accurate. This article contains some tips to help you get started with data management.

Regulations and Guidelines

Clinical trial regulations can be confusing and unwieldy to researchers. The intention of this section is to explain what regulations exist, where they apply and how to work through them in a sensible and pragmatic way to determine what is applicable to any given trial.

Informed Consent

The informed consent process is fundamental to ensuring that clinical trials are conducted ethically. This article outlines some issues to consider.