A leading ethicist says contract research organizations (CROs) need more oversight. “CROs are just out there kind of doing their thing,” said Arthur Caplan of the University of Pennsylvania. “They need to be the object of more regulatory attention partly just to establish how well they are doing. It will take a scandal a la Chinese lead paint in toys for that to happen.” Here’s the story in the San Jose Mercury News.
The New York Times and JAMA say the recent Vytorin controversy has U.S. politicians claiming to rethink an FDA plan to allow easier reprint distribution. One new concern in Washington: whether even elite journals are routinely publishing articles that appear to be written in universities, but are actually ghostwritten by sponsors. A Blue Cross association and the usual anti-industry groups oppose the FDA’s proposed loosening of current rules. “You don’t know the publication’s true peer-review standards and transparency,” says Richard Daines, New York State’s health commissioner.
The chief financial officer of Encorium Group resigned. Lawrence Hoffman’s departure is effective on May 2. The company said: “On behalf of the entire Encorium organization, we wish Larry good luck in his future endeavors and thank him for his role in the growth of the company.” Here’s the release.
Patient diary firm PHT hired Charles Bratton, who has 25 years of experience in the clinical and life sciences arena. PHT president and CEO Phil Lee said the appointment will help the firm work with contract research organizations: “His experience with developing CRO partnerships and as a business leader in the industry will enable PHT to further improve our partnership program.”
Obrem Capital acquired a 5.1 percent stake in MDS Pharma, the Seeking Alpha blog reports. The hedge fund managers “believe that significant shareholder value could be created through the spin-off or sale of one or several of the issuer’s business units and they intend to recommend that the issuer formally hire financial advisors to explore such strategic alternatives.” Here’s that post.
A study of clinical trial registries suggests that industry-sponsored trials often omit required investigator contact information. Medical journal editors prefer that registries such as www.clinical trials.gov and the International Standard Randomised Controlled Trial Number Register (ISRCTNR) have such information. Government-sponsored research always does. But only 41 percent of industry-sponsored trials listed the name of the study chair, principal investigator (PI) or site PI. “A substantial proportion of registered clinical trial entries are noncompliant with providing critical study e-mail contact information that is mandated by the registry,” note Melanie Sekeres and colleagues. One caveat. Her group only inspected trials listing a Canadian co-author, potentially skewing its analysis, which was published a few months back in the online journal PLoS Clinical Trials.
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