Industry efforts to address patient recruitment challenges have widely overlooked an important issue: What happens to patients who volunteer to participate in a clinical trial but do not meet the eligibility criteria? How well does the industry do in helping them find other trial opportunities? When patients volunteer for a clinical trial but are disqualified during the screening process, for any number of reasons, many are disappointed and disillusioned, and give up on participation altogether. While in the past, the industry has not addressed this issue, recent initiatives have emerged that allow companies to share more information about trials actively enrolling and redirect volunteers who don’t qualify for one study into other studies. In one groundbreaking effort…
Sponsors, CROs demanding more from pre-study site visits
Under increasing pressure to shorten the drug development life cycle and boost efficiency, sponsors and CROs are demanding more from the pre-study site visit. They’re now more likely than in the past to use historical data and external sources of information to evaluate site potential before the visit. Once underway, the more sophisticated—and successful—site visits probe deeply into patient recruitment ability. For those sponsors and CROs that treat it as a proforma visit, or delegate the visit to a poorly trained or uninformed CRA, it can result in a missed opportunity and waste of resources...
Eye on BioMarin
BioMarin’s mission statement is “making a meaningful impact in the lives of patients suffering from diseases that are often underserved and ignored,” primarily by replacing deficient enzymes in rare genetic diseases. Currently the company is marketing four products: Naglazyme (galsulfase) for mucopolysaccharidosis VI (MPS VI), Aldurazyme (laronidase) for mucopolysaccharidosis I (MPS I), Kuvan (sapropterin dihydrochloride) for phenylketonuria (PKU) and Firdapse (amifampridine phosphate) for Lambert Eaton Myasthenic Syndrome. Collaborations with research scientists and universities…
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