Expanding Access to Investigational Therapies for HIV Infection and AIDS (1991) / Chapter Skim
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3 EVALUATION OF EXPANDED ACCESS PROGRAMS
3 EVALUATION OF EXPANDED ACCESS PROGRAMS
Pages 27-34
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From page 27... ...
The underlying problem, described in Chapter 1, is that patients and FDA officials had very different expectations about what the treatment IND would accomplish. FDA officials regarded the rules as an opportunity to make drugs available to patients with lifethreatening conditions and no treatment alternatives, but only after the acquisition of clinical evidence that a drug was relatively safe and probably effective.
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From page 28... ...
POTENTIAL RISKS Drug regulators have indicated their willingness to begin parallel track programs concurrently with the beginning of phase 2 trials. Patients and their physicians must understand, however, that scientists may have very little information about the potential adverse effects of a drug at that time.
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From page 29... ...
In contrast, parallel track protocols enable thousands of patients with diverse backgrounds and medical histories to get access to drugs after minimal testing in a highly selected subgroup. The incidence of adverse effects in patients weakened by repeated battles with Pneun~ocystis carinii and other microorganisms, or by the effects of intravenous drug abuse, could be very different from that observed
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From page 30... ...
Safety Data The proposed policy statement on the parallel track developed within the Public Health Service indicates that all physicians participating in a parallel track protocol should be required to report safety data (the collection of efficacy data depends on the specific protocol; see Chapter 4~. Some observers have suggested that this requirement is too stringent-that mandatory reporting should not be part of a program designed primarily to increase access to therapy for desperately ill patients with no treatment alternatives.
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From page 31... ...
They suggest that improved patient education and better trial design (see Chapter 4) will ensure patient accrual in the randomized trials and, at the same time, allow patients who are ineligible for clinical trials to receive experimental drugs through expanded access programs.
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From page 32... ...
As of January 1991, there were more than 14,000 patients receiving ddI through expanded access programs and approximately 1,600 patients participating in the trials, which are about 75 percent filled. Most scientists associated with the trials seem to feel that some eligible patients must have been diverted from the trials by expanded access.
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From page 33... ...
The extent of data collection efforts to be included in the parallel track is a complex issue. Ideally, basic demographic data and some clinical indicators of efficacy and toxicity should be collected in a format similar to that used for conventional clinical trials.
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