Expanding Access to Investigational Therapies for HIV Infection and AIDS (1991) / Chapter Skim
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4 CREATIVITY IN CLINICAL TRIALS
4 CREATIVITY IN CLINICAL TRIALS
Pages 35-44
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From page 35... ...
This chapter explores the drive for innovation in clinical trials and the possibility of including expanded access protocols as part of the broad spectrum of drug evaluation mechanisms. THE CHANGING ENVIRONMENT Since the beginning of the AIDS epidemic, persons infected with HIV and their advocates have complained about the conservative nature of the drug development and evaluation process.
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From page 36... ...
Scientists are exploring new ways to modify the standard three-phase approach to drug evaluation-to improve efficiency without undermining the reliability of results. Other proposals include establishing preference trials, devising large-scale trials with broad eligibility requirements and limited data collection (similar to the International Studies of Infarct Survival in Europe)
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From page 37... ...
These procedures are especially important in HIV infection, which has an erratic clinical course and many different patterns of illness. The challenge for AIDS investigators is to retain the advantages of traditional clinical trials and at the same time reduce entry restrictions.
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From page 38... ...
Critics argue that previous experience in drug investigation indicates that nonrandomized trials do not give reliable results. Too many factors can influence drug choice and clinical outcome.
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From page 39... ...
But scientists who are currently experimenting with preference trials answer that blind insistence on randomized controlled trials as the only appropriate method for evaluating drugs has limited our ability to discover the true value of most of the treatments available toda~because such trials are costly, difficult to complete, and, when completed, apply only to the particular subset of patients who met eligibility criteria. They believe that there are ~good" and "bade studies of all kinds and that alternatives to RCTs must be judged by how well they answer important questions and by the quality of their execution.
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From page 40... ...
For example, the effects of a drug may be evaluated by simultaneously varying doses and schedules; this is an example of a two-factor experiment. Factorial designs promote efficiency by addressing multiple questions simultaneously, including questions of drug-drug interactions.
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From page 41... ...
Rapid implementation of large-scale randomized studies could greatly reduce the need for programs designed solely to increase access because most patients who could not quality for current clinical trials would be eligible for trials with broadened eligibility requirements. Efficacy Data Whatever their size, parallel track programs are unlikely to provide substantial information about the efficacy of drug candidates.
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From page 42... ...
If early parallel track and treatment IND programs remain the only alternatives to conventional clinical trials, they could play a vital role in the identification of important adverse reactions. Some believe that they also could provide some information about "real-world drug interactions and drug resistance.
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From page 43... ...
For example, the "safety valve" represented by the parallel track might relieve pressure to modif,r exclusion criteria or to take other actions that would make conventional trials more effective. Widespread distribution of a drug through early expanded access programs also could lead to inordinate pressures to approve drugs for marketing before scientists have gathered adequate clinical evidence of safety and efficacy.
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