Good clinical practices in research

By Humberto Reynales MD, MSc, PhD

Good Clinical Practice in Research or GCP Good Clinical Practice for its acronym in English is the training par excellence in clinical research. We have all done one of these trainings at some point, either in person or virtual depending on the moment and the urgency of doing it. This is the training required by all agencies, sponsors and CROs, and there is no question that it contains the essence of how a clinical study should be conducted.

The GCPs or BPCs were issued in 1996 at the International Conference on Harmonization between Europe, the United States and Japan, and subsequently the other countries have joined and today their acceptance and adoption by the regulatory agencies of the world where clinical studies are carried out is almost universal.

It is true that its name is somewhat confusing because it seems that it refers more to medical practice than to the rules for the development of clinical studies. But it may also be true that in 1996 that was not a term used to refer to good clinical practice for patient care and it was adopted for drug research.

 But in addition to referring specifically to clinical trials in their different phases, we see how it has been adopted for the development of other types of epidemiological studies and has become a requirement for some sponsors and ethics committees. Of course, in these cases it is not always fully adaptable because if there are no medications involved, there is no way to apply certain points of the rule. What is common is the protection of the subjects, but the risk is minimal when there is no intervention involved in the planned study.

Research Centers must of course comply with training in GCP or GCP but we must not forget that the training and development of competencies being the fundamental axis for the development of professionals who work in clinical research, leading to the formation of groups solid that with adequate processes ensure quality; We cannot just stay with GCP / BPC training. It is necessary not only to deepen the training in GCP / BPC but also to identify other important topics for the center and for the proper development of clinical studies.

What about the time and resources to train the center’s staff? This is a common problem. There is not always the time required due to the multiple occupations of the staff and resources are always scarce. We therefore need more practical and economical ways to train personnel, but we must also ensure that we have an organized and meaningful training program that must be offered to teams in research centers and also adequate for each of their functions.