PubMed · 7661506
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D A Blandino. 1995-10-01. Information for readers.. https://doi.org/10.7326/0003-4819-123-7-199510010-00019
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OBJECTIVE: To better understand how community advisory boards (CABs) can be used to improve the quality of HIV prevention trials. DESIGN: Data collected included descriptive and epidemiologic reports, ethnographic observations, and face-to-face semistructured qualitative interviews with 67 CAB and research team members. Interviews were coded for themes related to community-based consultation. SETTING: The study was conducted at 6 sites of the HIV Prevention Trials Network-Los Angeles, California; Birmingham, Alabama; Philadelphia, Pennsylvania; Harare, Zimbabwe; Lima, Peru; and Chiang Mai, Thailand. PARTICIPANTS: Thirty-six CAB members and 31 research team members, identified with the assistance of research staff at each site, were recruited for interviews across the 6 sites. RESULTS: Both "broad community" and "population-specific" models were identified as strategies for CABs to represent potential participants in HIV prevention trials. CABs viewed their role as a bridge between the research team and trial participants. CABs improved prevention clinical trials by assisting in protocol development, recruitment, and retention. In addition, CABs both identified and helped resolve ethical issues in clinical trials. CONCLUSIONS: When given time to develop, CABs appear to be a good strategy for building partnerships between researchers and communities for collaborative research projects. This approach has the potential to build sustainable capacity to identify and address ethical issues in research as well as community needs.
With the increasing pace of drug development, it is not unusual for several promising treatment regimens to be ready simultaneously for testing in a randomized phase III setting. Various limiting factors, including the time needed to transfer research results to clinical practice and a narrow 'window of opportunity', may make it unfeasible to perform trials to test such regimens sequentially against a control treatment in a traditional two-arm parallel group design. We present an approach to trial design based on eliminating inferior contenders at an early stage, allowing through to a second stage only treatments that show a predefined degree of advantage against a control treatment. The first stage of testing utilizes a marker known to be a valid intermediate outcome measure or surrogate for the definitive outcome. The experimental arms are compared pairwise with control according to this intermediate outcome measure. Arms that survive the comparison enter a second stage of patient accrual culminating in comparisons against control on the outcome measure of primary interest. We show how the design may be realized in practice by considering hypothetically distinct trials at stages 1 and 2, each with their own operating characteristics. The overall operating characteristics are computed from the stage 1 and 2 size and power and the correlation between the treatment effects on the intermediate and primary outcome measures according to a bivariate Normal approximation. The correlation is estimated by bootstrapping individual patient data from previous trials. We illustrate the general approach in a design of a real trial of four new chemotherapy regimens for advanced ovarian cancer. The intermediate outcome measure is progression-free survival. An international randomized controlled trial using the new design is already under way.
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