The opportunities and challenges in conducting clinical trials globally

Abstract

Clinical trials using human subjects are an integral part of the approval of new drugs and biologics. According to Center Watch, 86% of US clinical studies fail to recruit the required number of subjects on time. It is therefore logical that pharmaceutical companies would turn to global outsourcing. Many of these trials are being conducted in developing countries. Accrual in developing countries can be 5–10-times quicker than in the US or Europe. However, clinical trials conducted in other countries differ in many respects. Thus, conducting clinical trials globally raises the concerns of regulatory authorities regarding the transparency, quality, accuracy, and carrying out of these trials following ethical norms. Although clinical research abroad is greatly facilitated by recent efforts to standardize regulatory procedures, and using new technologies has helped to standardize multinational data collection, the issues associated with the globalization of clinical trials still raises concerns about the ethics, adequacy of regulatory supervision of clinical trial, and accuracy and validity of results. This paper examines the impact of the trend being followed globally and presents an analysis of potential ways to capitalize on the associated opportunities while mitigating the challenges in conducting clinical trials globally.