Choosing Investigators Advocate Development

When selecting investigators for the pivotal Phase III clinical trials, the sponsor typically searches for physicians who are well-known specialists in a particular therapeutic area. These physicians are typically referred to as 'thought leaders' or 'opinion leaders' and include editors and authors of major textbooks or other publications and leaders in important medical societies. They may also be representatives on advisory committees to the FDA or other regulatory agency who will ultimately determine whether the drug is approved for marketing.

One goal of Phase IV studies is to expand the numbers and types of physicians who are using the product. While a few 'thought-leaders' may lend credibility when attempting to get a manuscript published in a key journal, they represent an extremely small percentage of physicians who will actually be prescribing the product. Physicians chosen for participation in Phase IV studies are those who can potentially increase market share by serving as regional and local advocates for the products, and are commonly referred by the business group. These are the physicians who may sit on formulary committees of hospitals, develop local treatment guidelines, see high volumes of patients, are active in local medical societies, and serve as consultants to the sponsor. In the USA, with increased use by managed-care organizations of a 'gatekeeper' generalist physician, use of family practitioners, general internists and gynecologists as clinical trial physicians may prove to be extremely beneficial for ultimate product acceptance. Generalists are often the physicians who will most prescribe a product and therefore should be given the opportunity to test it in phase IV trials.

0 0

Post a comment