FDA's Apparent Requirement for Additional Thesis

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The philosophy behind clinical trials goes back nearly fifty years, to the Kefauver-Harris Drug Amendments. The objective of a trial is twofold -- to understand the benefits and risks of a drug. The FDA has an obligation to the public that is just as great if not greater than their obligation to the industry. They are willing to support the industry through the most important approvals processes when necessary, such as with AZT. From the researcher's point-of-view, the requirements for additional data may be a pain, but they are also a pain for the FDA as well because of the additional resources they must dedicate to analyzing that data. There are a lot of sides to this debate.

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From the point-of-view of the researcher or the drug company, additional trial requirements and demand for larger data sets may be onerous, but it is worth considering the issue in the context of all stakeholders.

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