Clinical Trial History: Regulatory Guidelines and Requirements
The history of clinical trials from the point of view of regulatory guidelines and requirements is sometimes a study in medical tragedy. As the practice of medicine advances over time, we learn from successes and mistakes. Some of those mistakes seem obvious in hindsight but may not have been so clear-cut in real time.
For example, before the early 1900s, elixirs that were advertised as "medicine" often contained alcohol as their main ingredient, and many caused harmful effects. The Pure Food and Drug Act passed in 1906 aimed to set things right by requiring that a drug label could not be false or misleading in any way and requiring that certain ingredients (including alcohol, heroin, and cocaine) be listed.
On the other hand, some regulations were put in place to make drug development more efficient worldwide (such as the international harmonization guidelines in 1990) or faster in the U.S. (with the implementation of PDUFA fees in 1992).
Browse key moments in clinical trial history in the graphic summary below
References, for more information:
- Part I: The 1906 Food and Drugs Act and Its Enforcement: https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/part-i-1906-food-and-drugs-act-and-its-enforcement
- Milestones in U.S. Food and Drug Law History: https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/milestones-us-food-and-drug-law-history
- ICH History: https://www.ich.org/page/history