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:          
CWWeekly

April 27

Doctors, patients in the U.S. and U.K. agree: Mobile health apps are good for our health

AARP teams with Georgia Tech's HomeLab, Pfizer and UnitedHealthcare to test wearables with consumers 50+

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

Already a subscriber?
Log in to your digital subscription.

Purchase the March issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

Already a subscriber?
Log in to your digital subscription.

Purchase the February issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs