Clinical Trials in Changing Times

Kelly, Evelyn B. Ph.D.

• This article, which contains highlights from the Society of Clinical Research Associates' (SoCRA) 14^th annual conference Applying Technological and Knowledge Advances to Clinical Trials (www.socra.org), was written by Evelyn B. Kelly, Ph.D. She may be contacted via e-mail at [email protected].

Reprints of this article are available. For more information visit www.drugandmarket.com/journal and click the "Reprints" link.

Drug & Market Development 16(12):p 1193-1197, December 2005.

• Protection of human subjects is an evolving process, triggered by a combination of high costs, slow results, and the nature of the next human tragedy of research. Medical tragedies are great motivators for change.

• FDA's Critical Path Initiative has implications for the Good Clinical Practice Program (GCP) and the conduct and oversight of clinical investigations.

• Ethical concerns and controversies will rise as U.S.-sponsored research increases in developing countries.

• Researchers must work to build trust and enhance credibility. This task involves being honest with ourselves and with the public, complying with high ethical and legal standards, and being transparent and sensitive to the public.

• The procedure of informed consent involves two actions: the process of communication between an investigator and a research subject that results in a document. Informed consent is a process, not just a piece of paper.