Clinical trials. A place for randomization in the interval between the end of recruitment and availability of results.

ABSTRACT

There is a time delay between the final recruitment of patients to a randomized controlled trial and the publication of results. The practical options available to decision makers during this gap can be listed according to whether all treatments are already widely available or whether at least one has been restricted to the trial. When the treatments are already in widespread use, the options are simply either to stop randomizing or to continue. When one trial treatment is restricted, there are further options a) withdraw the restricted treatment altogether, pending the final analysis; b) continue to offer randomization, with a view to providing further data should these be needed; or c) make the intervention widely available to patients who would have previously been eligible for the trial. In this paper, we discuss the relative advantages and disadvantages of each option and discuss their attendant ethical implications. In particular, we suggest that continuing randomization is an option worthy of serious consideration. Randomizing patients acts as a "hedge" against the need for more data, given that sample size calculation is an inexact science. However, patients must be made aware of the basis on which randomization is offered.