The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs).
Around half of the clinical trials done on medicines we use today are not published; a tragic truth that needs to be changed.
Informed consent is vital in clinical research. Achieving adequate comprehension in low literacy settings however is a significant challenge.
Professor Lang talks about doing difficult trials in difficult places - including malaria and ebola trials.
The SWAT and SWAR programme is identifying issues about the methods of trials and systematic reviews about which there is sufficient uncertainty to justify research to support well-informed decision making about future designs and choices.
New guidelines help researchers undertaking systematic reviews and IPD meta-analyses to report their findings in a full and transparent manner.
Ebola PPE guidelines - urgent need to revise WHO and CDC guidelines. This video shows an excerpt from keynote address 'The fuss about face masks', Professor Raina MacIntyre from the School of Public Health and Community Medicine, UNSW Australia.
Five keys to improving research costing in low- and middle-income countries
by ESSENCE on Health Research InitiativeESSENCE 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.
This guide, developed by the WHO and released in December 2013, aims to facilitate implementation research in LMICs.
Good Clinical Practice in Resource-Limited Settings: Translating Theory into Practice
by The Editorial TeamResearch 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.
Towards a more pragmatic approach to trial regulation
by The EditorsFive seed documents are provided here for use in clinical research, which can be adapted and altered for each study. Here we provide a template concept protocol, a study protocol, a CRF, an informed consent form, and a generic SOP.