Are there risks to participating in pharmaceutical trials?
There is an element of risk to everything, including walking across the street or driving to the grocery store, therefore the answer is “yes.” However, we reduce the risks as much as possible. All clinical trials in the United States must be approved by an independent review group (called an “Investigational Review Board,” or IRB). The IRB is responsible for evaluating the ethics of the trial and to ensure that subjects’ rights and welfare are protected. The IRB is comprised of respected individuals from a number of institutions who are independent and have no direct interest or participation in the study. They may review the data while a clinical trial is in progress to assess safety considerations. Although we cannot eliminate all risk, a fundamental ethical requirement for any investigator is to conduct the clinical trial with adequate safety provided for all of the participants.
Related Questions
- Why would international or Australian pharmaceutical companies place their trials in Australia when there are providers of the same services in the US?
- Why do pharmaceutical companies increasingly shift their clinical drug trials to developing countries?
- How can pharmaceutical companies ensure that trials proceed in a timely and cost-effective manner?
