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4 Content of a Clinical Trial Registry
Pages 19-34

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From page 19...
... GUIDING PRINCIPLES AND GOALS FOR CLINICAL TRIAL REGISTRIES Based on the premise that registries must provide the public with sufficient information to provide public health and safety benefits, the committee's initial discussions suggested that the following guiding principles were desirable for a clinical trial registry: · Be global in perspective. · Offer access to the public at no charge.
From page 20...
... However, a clinical trial registry is NOT intended to replace the advice of a health care professional regarding benefits and risks nor is it intended to replace the comprehensive information on a product label as required by the relevant regulatory authorities. It is also not intended to replace peer-reviewed publication -- although the veracity of journal publications could be better assured by the presence of a transparent and more comprehensive mandatory clinical trial registry.
From page 21...
... Eli Lilly's patient surveys indicate that people considering or enrolling in a clinical trial want to ask questions and engage in discussion with a live person. Jerome Yates, representing the American Cancer Society, stated that 90 percent of patients who query a clinical trials source need follow-up answers to their queries.
From page 22...
... Hugh Tilson, Centers for Education and Research on Therapeutics, described the development of a clinical trial registry as a "huge social intervention, which therefore requires proper evaluation," including costeffectiveness analysis. Any registry approach developed needs to be pilot tested.
From page 23...
... , the international pharmaceutical industry, and WHO -- are broader than the requirement for ClinicalTrials.gov, which calls for posting of trials regarding serious and lifethreatening conditions. These groups would require registration of all prospective, hypothesis-driven, interventional clinical trials (i.e., all confirmatory trials, not just those for serious or life-threatening illnesses and conditions)
From page 24...
... Phase II trials are well-designed trials for the most part. "They may have multiple hypotheses and be exploratory in that sense, but they're often used as part of the critical database." William Vaughan sent a statement from Consumers Union to the IOM website: "It is essential that the goals, specifications, and endpoints of clinical trials be registered and made public." He added, "Though in some cases it may not be necessary to register and disclose results from Phase I and some Phase II trials, we urge the Institute to err on the side of more public information, not less." Industry representatives expressed concern that early exploratory studies should not be included for the following reasons: · Early exploratory trials are designed only to set direction (i.e., to generate hypotheses)
From page 25...
... . BIO has endorsed the concept of a clinical trial registry for marketed products, but has not supported a requirement for registering clinical trials involving drugs that are not available for commercial use.
From page 26...
... TABLE 4-1 Clinical Trial Registry Data Fields Discussed at IOM Meetings Information to be registered when a clinical trial is initiated Information to be registered for completed clinical trials # Clinical Trial Data Field Description -- to be registered prior to the first patient visit in a study 1. Unique Trial Identification Number 2.
From page 27...
... Definition of Primary and Secondary Outcome Measures 16. Key Trial Dates: Registration Date, Trial Start Date (anticipated or actual)
From page 28...
... . The physicians working on the clinical trial also have full access to the hypothesis being tested, the intervention and comparison arms, the protocol-specific hypothesis statement, and a complete listing of primary and secondary outcome measures as part of the detailed clinical trial protocol.
From page 29...
... Annetta Beauregard, from Eli Lilly and Company, clarified that for the majority of cases, all the fields -- the intervention, the primary and secondary outcome measures -- will be on the Web before the first patient is enrolled. Delayed disclosure will be sought in a minority of cases.
From page 30...
... "In our discussions with a number of commercial sponsors of clinical trials, the idea has come up to place the details of clinical trials in a so-called `lockbox,' which would be a way of assuring that the trials were carried out the way that they had been proposed, but that the detailed information wasn't going to be widely available at the time the trial was either planned or completed," he said. He asked the patient representatives in particular what they thought of this approach.
From page 31...
... Sandrock commented that "a registry that does not include primary and key secondary outcome measures would ring hollow to me and probably to the public as well." He continued: If a company chooses to employ a novel outcome in a Phase II or exploratory trial, that outcome could be listed in the registry in enough detail to give the reader an accurate view of what is being measured but not specific enough for others to emulate. For example, an outcome measure in a neurodegenerative disease trial could be listed as the 12-month change in regional brain atrophy as measured by magnetic resonance imaging (MRI)
From page 32...
... "We can't deal with results reporting until we can get the trial existence part right." The editors also expressed concern that showing the results of poorly done clinical trials is a disservice to the public. Posting results that have not gone through peer review may be dangerous.
From page 33...
... Item 17, results of clinical trials, is most problematic because results are data, not information: I cannot imagine the type of results or the level of detail that could be included in a registry that would provide truly valuable informa tion about clinical trials for the public. The proposal is to provide summary results.
From page 34...
... Zarin noted that NIH is working on a proposal to enhance access to a wider range of information on NIH-supported clinical trials -- with positive, neutral, or negative results. They see challenges, though, in reporting results, including verification of results and problems with misinterpretation.


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