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What are clinical trials and why are they important in drug development?

Clinical trials are studies to test the safety and efficacy of new therapeutic treatments, such as drugs or biologics. Clinical trial sponsors must obtain FDA approval before they may begin trials. The FDA requires sponsors to submit data showing safety and efficacy in animal models before they will permit testing in humans. Clinical trials can also be used to compare the safety and efficacy of different therapeutic treatments. To learn more about clinical trials and why they are important for drug development, click on the links below.

• International Psoriasis Council: The Evolution of the Clinical Trials Process – A Brief History Lesson
• MedlinePlus: Clinical Trials Tutorial
• National MS Society: Glossary of Clinical Trial Terminology

Testimonials: How we did it

Relevant publications

Related Tools

Finding Clinical Trials

• EU: ClinicalTrialsRegister.eu
• NLM: ClinicalTrials.gov

Guidance & Training for Running Clinical Trials

• FDA: Running Clinical Trials
• International Psoriasis Council: It Takes a Village to Conduct a Clinical Trial
• FDA: Clinical Trials and Institutional Review Boards
• FDA: Clinical Investigator Training Course
• Society of Clinical Research Associates: FDA Clinical Trials Requirements, Regulations, Compliance, and GCP Conference