It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North–South collaborative trials

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).

Multimedia informed consent for low literacy populations

Informed consent is vital in clinical research. Achieving adequate comprehension in low literacy settings however is a significant challenge.

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.

Difficult Trials in Difficult Places

Professor Lang talks about doing difficult trials in difficult places - including malaria and ebola trials.

Ebola PPE guidelines

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

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. 

Implementation Research in Health: A Practical Guide from the WHO

This guide, developed by the WHO and released in December 2013, aims to facilitate implementation research in LMICs.

Towards a more pragmatic approach to trial regulation

Study documents

Five 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.