John R. Hoffman is a Professor of Biology, public speaker and a scientist examining the recovery of the nervous system after injury. Since 2006 he has written several unpublished manuscripts and he is currently working on the first Nathaniel Smythe novel and short story collection. He spends his spare time with his family and running.

19 Understanding Clinical Trials

Objectives

By the end of this lecture, the student will be able to:

  1. Describe the specific goals of the different levels of clinical trials.
  2. Explain the importance of positive attitude in the treatment of diseases.

Understanding Clinical Trials

This short video lecture provides an overview of clinical trials for the development of new drugs.The handout for this presentation can be downloaded and printed.

Reading:

Understanding Clinical Trials. ClinicalTrials.gov. U.S. National Institutes of Health.

Assignment: Cure Interrupted

Patients upset over end of Parkinson’s Drug Trial: Risks associated with experimental drug leave patients patents in limbo. (December 28, 2004). ABC News.

Cure Interrupted? Human Guinea Pigs Bewail Withdrawal of Experimental Drug (September 11, 2005). CBS News.

Human Guinea Pigs (video). (September 13, 2005). CBS News, 60 minutes. (approximately 3 minutes).

In your small group, discuss if sponsors of a clinical drug trial follow the absolute mandate and requirements established in the Belmont Report and the Food and Drug Administration and terminate a study, even though the subjects want to continue receiving access to the experimental drug. Assume that the experimental drug in question does not appear to have a documented therapeutic effect and does not appear to have any harmful side effects.

Previous – 18 – Diseases and their causes

Next – 20 – Costs of prescription drugs