The CenterWatch Monthly, November 2012

Thursday, November 1, 2012 08:00 AM

Keeping potential patients connected to trials

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…

 

To read the full articles for this issue of The CenterWatch Monthly, please click here for subscription information.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

August 18

Ebola outbreak highlights need to improve biosafety, infrastructure to handle future health emergencies

More African American professional women open to participating in medical research

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

Already a subscriber?
Log in to your digital subscription.

Purchase the August issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

Already a subscriber?
Log in to your digital subscription.

Purchase the July issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs