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 suspension of the treatment protocol for four clinical trials. We also examined how data collected after the suspensions were used. All four trials were designed to evaluate treatments for cytomegalovirus retinitis in patients with AIDS and were conducted by the Studies of Ocular Complications of AIDS Research Group. Documentation that patients were notified of the results varied from 62--100% with three of the four studies documenting the process for > or =92% of patients. The median time between the recommendation 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 analyses 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, they did not alter the conclusions about safety and efficacy from the randomized portion of the trial. Control Clin Trials 2001;22:62-68
Holbrook
J T
JT
The Center for Clinical Trials, The Johns Hopkins University School of Hygiene and Public Health, Baltimore, MD, USA.
Meinert
C L
CL
Jabs
D A
DA
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy*; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D017726:Cytomegalovirus Retinitis / Q000188:drug therapy*; D003625:Data Collection / Q000706:statistics & numerical data; D005500:Follow-Up Studies; D006801:Humans; D015337:Multicenter Studies as Topic; D010043:Outcome and Process Assessment, Health Care; D010353:Patient Education as Topic
D000998:Antiviral Agents