Patient notification and follow-up after suspension of treatment protocols: Experience from four clinical trials of treatments for AIDS-related CMV retinitis

We reviewed procedures for and data about patient notification of the suspe nsion of the treatment protocol for four clinical trials. We also examined how data collected after the suspensions were used. All four trials were de signed to evaluate treatments for cytomegalovirus retinitis in patients wit h AIDS and were conducted by the Studies of Ocular Complications of AIDS Re search Group. Documentation that patients were notified of the results vari ed from 62-100% with three of the four studies documenting the process for greater than or equal to 92% of patients. The median time between the recom mendation for protocol suspension and patient notification varied from 7-49 days with three of the four trials at 12 days or fewer. Most of the analys es of data collected after the suspension of the treatment protocol did not focus on comparisons among treatment groups. Although they provided useful information about the long-term outcomes and the nature of the disease, th ey did not alter the conclusions about safety and efficacy from the randomi zed portion of the trial. (C) Elsevier Science Inc. 2001.