The central role of health research in improving health and stimulating national economic growth is now well established. Thus, the past few years have witnessed the expansion of health research activities in developing countries. The quality of this research still needs to be strengthened to overcome the issue that research done in developing countries remains unrecognized with limited potential for social and economic impact.
It is widely known that effective new health technologies cannot be successfully implemented when these technologies are scaled up. There is a significant need of particular research to identify solutions and options for overcoming implementation obstacles in health systems, disease control programmes and health care delivery. This form of research (also known as implementation research) addresses implementation bottlenecks, identifies optimal approaches for a particular setting, and promotes the uptake of research findings: ultimately, it leads to improved health care and its delivery.
Good Clinical Practice is an international ethical and scientific standard for designing, conducting, analyzing and reporting clinical trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and wellbeing of trial subjects are protected. It also ensures the credibility of the trial data. The subject of GCP has become an international significance. Sponsors of clinical research generally demand that all research activities must be delivered according to the GCP standard.
Good Clinical Laboratory Practice (GCLP) is a guideline in using laboratory samples for clinical studies. For some years, it has been internationally recognized that clinical laboratories processing specimens from clinical trials require an appropriate set of standards to guide good practices. Good Clinical Practice (GCP) is not designed for laboratories and Good Laboratory Practice (GLP) focuses only on pre-clinical analyses and not on human samples from clinical trials. Therefore, the British Association of Research Quality Assurance (BARQA) suggested in 2003 a guideline to close the gap. It was agreed that GCLP would be a valuable tool for improving and assuring quality laboratory practice in clinical trials. It was recognized that the GCLP Guidelines were not widely available, and it was recommended that WHO/TDR publish the guidelines on its website as the standard for laboratories undertaking samples from TDR-supported clinical trials. The TDR Diagnostics Evaluation Expert Panel (DEEP) has since recommended GCLP as the standard for clinical laboratories involved in the evaluation of diagnostics for infectious diseases. The spirit of this course is to disseminate and share the experience and knowledge on GCLP particularly in developing countries with its limitation in lab facilities.