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

There is a time delay between the final recruitment of patients to a random ized controlled trial and the publication of results. The practical options available to decision makers during this gap can be listed according to wh ether all treatments are already widely available or whether at least one h as been restricted to the trial. When the treatments are already in widespr ead use, the options are simply either to stop randomizing or to continue. When one trial treatment is restricted, there are further options: a) withd raw the restricted treatment altogether, pending the final analysis; b) con tinue to offer randomization, with a view to providing further data should these be needed; or c) make the intervention widely available to patients w ho would have previously been eligible for the trial. In this paper, we dis cuss the relative advantages and disadvantages of each option and discuss t heir attendant ethical implications. In particular, we suggest that continu ing randomization is an option worthy of serious consideration. Randomizing patients acts as a "hedge" against the need for more data, given that samp le size calculation is an inexact science. However, patients must be made a ware of the basis on which randomization is offered.