Operational challenges in large clinical trials: examples and lessons learned from the gambia pneumococcal vaccine trial.

The requirements for Good Clinical Practice (GCP) in clinical trials are well documented [1], and ethical issues are hotly debated [2]. Operational aspects of trials, however, have received far less attention [3], perhaps due to restrictions on journal space for detailing methods. In low resource settings, however, large trials often face many logistical and organizational obstacles, and thus the practical difficulties in running a trial to GCP standards should not be ignored. Here, we describe the main operational challenges to a randomized, double-blind, placebo-controlled trial of the safety and efficacy of pneumococcal conjugate vaccine among over 17,000 infants in the Gambia. The trial began in August 2000, and after the magnitude of the challenges were recognized, a new senior principal investigator (FTC) and project manager (FGY) were recruited, taking up post in June 2001. We summarize here the major lessons learnt in trial implementation in a resource-poor setting.