Controlled clinical trials
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Control Clin Trials · Feb 2001
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialCloseout of four phase II Vanguard trials and patient rollover into a large international phase III HIV clinical endpoint trial.
Large phase III clinical trials typically require many years of planning and preparation. During this time, proposed study methods and overall trial feasibility can be assessed in smaller pilot studies. However, the patients enrolled in these pilot studies are not routinely included in the larger study. ⋯ Specifically, the reconsent process, the data collection transition plan, and the steps taken to minimize bias due to differential reconsent according to the assigned treatment arm in the phase II trial are described. The procedures employed are relevant to the reconsent of patients for long-term follow-up at the completion of clinical trials. Control Clin Trials 2001;22:42-48