Combating environmental causes of cancer.
نویسنده
چکیده
791 each agent with the control. The ability to test multiple therapies in a smaller population will become more important as disease subcategories are increasingly defined by specific phenotypic, biologic, and genetic markers, and the available number of patients in a given category becomes a limiting factor in conducting relevant studies. The collaborative trial approach permits direct evaluations of multiple new therapies, as well as comparisons between new and old therapies. The many variables limiting comparison across studies are eliminated, since therapies are tested in a single, defined population, with a common end point and a uniform study protocol and analytic plan. Of course, there are also limitations of collaborative studies. Such studies are possible only when several similar or relevant therapies are available for testing at the same time. New regulations might be required from the Food and Drug Administration to impose a clinical trial structure on companies with competing products, since companies are often in a race to get to market first. In addition, there are antitrust and patent issues associated with such collaborative trials that will require negotiation and possibly new legislation. Conflicts of interest must be avoided when conducting any clinical trial, and especially when conducting collaborative trials with corporate sponsors. It is essential to establish a firewall between the supporting corporations and the independent investigative group that designs the trial and manages and analyzes the data. We encourage discussion of these issues as part of the preparation for more frequent use of collaborative clinical trials, which will ensure that safe and effective therapies become available more quickly and at lower cost than they do today.
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ورودعنوان ژورنال:
- The New England journal of medicine
دوره 364 9 شماره
صفحات -
تاریخ انتشار 2011