FDA\'s Apparent Requirement for Additional

¶ … FDA's apparent requirement for additional data for submissions, it is the incremental increase in difficult that is of the most concern. There have always been difficulties with issues such as placebos and pediatric trials. Expanding the size of Phase I trials, however, is likely the most problematic. Should a Phase I trial include a placebo, then the difficulty becomes double.

We must look at the issue from the point-of-view of the patient in the trial. They are faced with an ailment -- sometimes life threatening -- and want to help improve the treatment. There is -- no matter much the subjects are paid or how desperately they need to find a new treatment for themselves -- an element of altruism involved. That makes it more difficult to find subjects for Phase I. The risks are great, and the rewards may amount to nothing. Expanding Phase I or introducing more placebo trials into Phase I is definitely going to make it more difficult to find people willing to take a risk for the greater good.

It may be quick to judge the FDA here, though. 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. 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.