Reuben, Baystate, Pfizer
Exclusive: Fraud Postmortem
A research scandal at a Tufts facility shows that peer review cannot identify scientific fraud quickly.
Which organizations are running the biggest, most complex portfolios of clinical trials in 2010? To find out, ClinPage analyzed the listings in ClinicalTrials.gov, the U.S. government's database of more than 80,000 research projects. Our exclusive list of the 50 largest ongoing studies is below. The list is a magnificently global one. Many of the top organizations tend…more...
A successful stand-alone investigator site—one not affiliated with an academic institution, a hospital or any other sites—is a rarity in clinical research. Most sites that try independence find that they can't find a steady flow of studies. Palm Beach Research Center is an exception. The 15-year-old, 25-employee investigator site chugs along with many Phase II and III…more...
The corporate parent of contract research organization (CRO) Chiltern bought MDS Pharma's central labs. Last week, private investment group Czura Thornton agreed to pay $8 million for the labs and an additional $4 million later if performance thresholds are met. The sale is part of Canadian conglomerate MDS Inc.'s continued selling of clinical assets, including MDS Pharma…more...
Those who do not know history are doomed to repeat it. Dogs do it. Frogs do it. Logs do it. (At least as long as they are part of the tree.) Companies do it. Even ones like GM, even if they have to be forced. Moving forward, I mean. Evolving. Keeping things that work and discarding things…more...
Not so long ago, Icon Clinical reached the final stage of getting regulatory approval for a large global project involving a new diabetes drug. As fate would have it, the FDA issued a warning letter about another drug in the diabetes category. The regulatory counterparts to the FDA elsewhere in the world said a collective whoa.In…more...
There are more active, commercial investigational new drug applications (INDs) circulating through the FDA than ever. Exactly 5,700 at the end of 2008. That's a record high—up 20 percent over the previous year. For now, clinical programs do not appear to have been affected by the larger economy. Numbers of filings are surging, too. A record 795…more...
Most of the ClinPage podcasts are done in a pretty typical Q&A format. Today, however, we're posting a different type of audio: some snippets from the 2009 Clinical Trials Congress, held earlier this year. We thank the Institute for International Research (IIR), which organizes a fabulous conference every year, for their permission to do this. The speaker…more...
So much for multimodal pain therapy. A leading proponent, anesthesiologist Scott Reuben, is watching his abruptly damaged reputation. The fraud continued for twelve years, from 1996-2008. More than twenty of Reuben's thirty peer-reviewed articles have been retracted or are being reassessed. It's a black day for peer review. The honor system. And anesthesiology. What industry critics will…more...
March 14, 2010
A research scandal at a Tufts facility shows that peer review cannot identify scientific fraud quickly.
Thoughts on the numerical implications of the impending mega mergers between Pfizer-Wyeth and Merck-Schering-Plough.
Reflections on the new year and what pharma should do to avoid a pounding from politicians.
To avoid lawsuits, train employees to pretend a lawyer is reading every email, text message and Microsoft Word document.
Despite a cancelled FDA pilot project, CDISC leaders explain why the ODM data standard still matters.
With ISO certification, a California firm tries to lower regulatory risks inherent in translation by ensuring high quality—and avoiding mistakes.
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