(2002; 166 pages)
Protection of trial subjects in clinical trials
Moderators: Dr Ramli Ghani, Malaysia, and Dr Rolf Spang, Switzerland
Clinical research is developing in terms of sophistication of scientific approach, ethical complexities, number of trial subjects, and multicountry involvement. Given the need for greater numbers of subjects, it may happen that soon much of clinical research will take place in developing country locations. However, research carried out in poor communities, particularly when funded by more affluent sponsors from developed countries, may raise complex ethical and legal questions for participants, regulators and ethics committees. Recently, many countries have either updated their Good Clinical Practice guidelines (GCP) or started more effective implementation of GCP principles. Regulators have an important role to play in protecting trial subjects. This session deals with the regulatory challenges resulting from this shift, and the need for a constantly improving regulatory framework for clinical trial management.