This guide, developed by the WHO and released in December 2013, aims to facilitate implementation research in LMICs.
New publication on rifampicin Mono-Resistance in TB
by Yacoob Mahomed Coovadia, Sharana Mahomed, Melendhran Pillay, Lise Werner, Koleka MlisanaResearch Link Nurse
by Nicola McHughA recent editorial in PLoS discusses the significance of transparency in reporting and publishing the studies and how scientific studies guidelines have evolved over time.
A “reverse pharmacology” approach for developing an anti-malarial phytomedicine
by Merlin Willcox, Bertrand Graz, Jacques Falquet, Chiaka Diakité, Sergio Giani, Drissa DialloA new "improved traditional medicine" for malaria was developed in Mali, using an innovative approach. Instead of starting with classical laboratory research on plant phytochemistry and pharmacology, the authors first observed the clinical effectiveness of herbal remedies in current use. This approach enabled them to select what appeared to be the most effective remedy among 66 others.
A template for writing a research protocol
by Joby GeorgePresentations from D Groups
Clinical Research Laboratories for Trials in Global Health in Central Africa
by ALI Innocent, akindeh, Prof Wilfred F. MbachamThe authors present the story of building a succesful research laboratory in Cameroon, including how they managed building up the infrastructure, equipment maintenance, staff training.
Technology issues for research in remote areas/developing regions
by Mike Workman - Senior ContributorResearchers can often be tripped up by issues they encounter in developing regions and remote areas. Although no definitive answers are provided (there are just too many options and unknowns), the following issues should be considered when planning such a trial.
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.
Good Clinical Practice in Resource-Limited Settings: Translating Theory into Practice
by The Editorial TeamPowerpoint 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 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.
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 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
by Yves ClaeysThis 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
by Khin Maung Lwin, Thomas J Peto, Nicholas J White, Nicholas P.J. Day, Francois Nosten, mparker, phaikyeongCommunity 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.
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
by Elizabeth Allen - Regional Faculty Lead, Lesley Workman - Senior Contributor, Cordelia ReddyOn 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.