Global ethical conduct of clinical research in the deveolping world under developed world sponsorship

The conduct of clinical trials for new drugs has undergone extensive globalization in the last 15 years, primarily through including patients from the developing world. In 1995, 1 in 10 investigators conducting FDA approval studies was located outside the USA; in 2008, that proportion was 1 in 3. Reasons for globalization include: Shortening time to proof of concept, Reduction in per-patient costs, Decreasing trial enrollment time, thereby hastening marketing approval and preserving the product's patent protection period. US/EU Regulatory agencies accept global clinical data from developing regions, provided the trials adhere to minimal ethical and quality standards. However, international guidelines clearly state that such assurances are the responsibility of trial sponsors. Since ministries of health and ethics committees in developing countries are generally poorly funded, and because this globalization is recent, few mandates exist empowering either group to compel sponsors to make long-term ethical commitments to countries hosting the trials. In this context, potential ethical concerns exist for host-country investigators if the trial sponsor has not made certain guarantees. These include: Availability of globally standard treatments, Continued access for participating patients, Legal commitment to market the products (if approved) at a locally affordable price in each country providing patients supporting registration. Strategies to empower Ministries of Health, Ethics Committees, Investigators and Patient Advocates in countries hosting sponsored research must be developed to ensure sustainable practices that preserve ethics, human rights and advances in healthcare on a global basis.