215626 Global ethical conduct of clinical research in the deveolping world under developed world sponsorship

Monday, November 8, 2010

Rafael Escandon, PhD, MD, MPH , Clinical Research and Development, Cytokinetics Inc, South San Francisco, CA
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.

Learning Areas:
Clinical medicine applied in public health
Ethics, professional and legal requirements
Public health or related public policy
Public health or related research

Learning Objectives:
Discuss developed world sponsors' ethical responsibilities to countries and communities hosting clinical research. Analyze historical successes and failures. Formulate plans and objectives to make global clinical research a sustainable practice.

Keywords: Bioethics, Clinical Trials

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: 15 years of global clincal trials experience, MPH in international health and human bioethics
Any relevant financial relationships? Yes

Name of Organization Clinical/Research Area Type of relationship
Cytokinetics, inc cardiology/oncology Consultant and Independent Contractor (contracted research and clinical trials)

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.