July-August 2019 (Volume 20, Number 4) : PDF
How genetics and genomics research are changing clinical trials
Patients with serious conditions that haven’t responded to existing treatments or who are at risk for hereditary diseases that have no cure often pin their hopes on researchers who are investigating next-generation medicine. And they hunger for the chance to be part of cutting-edge clinical trials. Genetic therapies — often referred to as personalized or precision medicine — are a tantalizing opportunity for both patients and the researchers who want to help them.
The Revised Common Rule, Six Months On
For decades, clinical trial ethical oversight has evolved to keep up with the truth that people — including clinical researchers — will not always follow protocols or will justify unethical ones. Over the past 25 years, the clinical trial sector has “dramatically changed” its practices to cultivate a patient-centric focus to ensure the means of a trial justify the ends.
The Evolution of the Common Rule
1947: Nuremberg Code. Following World War II, alleged Nazi leaders were prosecuted for war crimes. In one case, officially known as United States v. Karl Brandt et al. and commonly referred to as the Doctors’ Trial, 23 defendants (including 20 physicians)—all members of the Nazi Party—were charged with murder, torture and other atrocities committed in the name of medical science during the war.