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Biomedical Basics

Clinical trials

  • Created by Henry Stewart Talks
Published on December 31, 2025   4 min

A selection of talks on Pharmaceutical Sciences

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This talk introduces clinical trials, using it as a basis for further exploration of the purpose and structure of clinical trials in advancing evidence based medicine, including their phase design and stringent protocols. We will discuss the importance of randomization, blinding, and endpoint selection in ensuring unbiased, valid results. Ethical considerations and oversight mechanisms to protect participants will also be examined. Finally, we will explore the processes of data analysis, regulatory submission, and ongoing post marketing surveillance. Clinical trials are the cornerstone of evidence based medicine, enhancing our understanding of how interventions prevent, detect, or treat diseases. These interventional studies assign interventions to participants by protocol, providing strong unbiased data. They assess a drug's effectiveness, its safety, who benefits, and how it compares to existing treatments. Structured and regulated trials inform physicians, regulators, and policymakers shaping modern medicine. Trials are typically divided into four phases. Phase one studies involving few healthy volunteers or patients, focus on safety, tolerability, and pharmacokinetics. Phase two trials expand to more patients to explore early efficacy and side effects. Phase three trials are larger, randomized, and pivotal, providing evidence for efficacy and safety needed for regulatory approval. Phase four occurs post marketing to monitor long term effects.

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