Home

Good Clinical Practice in Resource-Limited Settings: Translating Theory into Practice

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.

Participant Retention Plan

Participant retention refers to keeping enrolled participants in a trial for the duration of the study. This article explains the concept of participant retention, and provides a template retention plan.

Electronic Source Data in Clinical Investigations by FDA

This is a nice guidance document on principles in electronic data capture from Industry perspective (FDA)

The practicality and sustainability of a community advisory board at a large medical research unit on the Thai-Myanmar border

Community engagement is increasingly promoted to strengthen the ethics of medical research in low-income countries. One strategy is to use community advisory boards (CABs): semi-independent groups that can potentially safeguard the rights of study participants and help improve research. However, there is little published on the experience of operating and sustaining CABs.

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.

Critical issues in conducting non-commercially sponsored clinical research in South Africa: Meeting report 1st Feb 2013

On 1st February 2013, Global Health Trials Southern African Regional Faculy held the first of its Clinical Trials Skills-Sharing Workshops in South Africa, hosted by the University of Cape Town. Here you can find the presentations from the day.

Clinical Trials in East Africa: a One-Day Skills Sharing Workshop Report

Report on a one-day skills sharing workshop for improved clinical trials and research in East Africa, hosted by UVRI/MRC, EACCR and Global Health Trials and held on 15th February 2013.

Global Nutrition Epidemiology and Trends

The universal coverage with the full package of these proven interventions at observed levels of program effectiveness could prevent about one quarter of child deaths under 36 months of age and reduce the prevalence of stunting at 36 months by about one third. I attach my recent review on the possible strategies to combat malnutrition include promotion of breastfeeding, dietary supplementation of micronutrients, prevention of protein-energy malnutrition, and hygiene of available weaning foods and how best topackage these intevrentions for universal scale-up.

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.

Repository on maternal child health: Health portal to improve access to information on maternal child health in India

This article describes a health portal developed in India aimed at providing one-stop access to efficiently search, organize and share maternal child health information relevant from public health perspective in the country.

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.

The benefits and harms of breast cancer screening: an independent review

Whether breast cancer screening does more harm than good has been debated extensively. The main questions are how large the benefit of screening is in terms of reduced breast cancer mortality and how substantial the harm is in terms of overdiagnosis, which is defined as cancers detected at screening that would not have otherwise become clinically apparent in the woman's lifetime. 

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.