January 21, 2019irb

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Reuben, Baystate, Pfizer

Exclusive: Fraud Postmortem

March 20, 2009

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 More than twenty of Reuben's thirty peer-reviewed articles have been retracted or are being reassessed.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 do with the scandal remains to be seen. The case could provide fodder for anti-industry politicians intent upon demonizing pharmaceutical research. For his part, Reuben doesn't appear to be facing legal problems. Or the loss of his livelihood. No one is alleging any patients were harmed under his care. But the longtime Pfizer collaborator is taking a bit of a vacation. He isn't answering email. Major Mess To its credit, the Springfield, Mass. branch of the Tufts network, Baystate Health, is answering painful questions. It didn't employ Reuben; he worked for an independent anesthesiology…more...

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Finding Quality and Speed

IRB Selection Tips

February 04, 2009

Say your institutional review board (IRB) is stumbling, bungling paperwork, taking too long to approve—or not approve—your trial. It’s time to pick a new one, but you’ve had this IRB so…more...

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IRBs Are Next

Brazil’s CRO Association

December 15, 2008

Brazil is one of only two Latin American countries (besides Argentina) to have its own contract research organization (CRO) association, and one of only a handful of countries on Earth to…more...

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Coast: Ethics & Efficiency

Inc. List’s Only IRB

August 29, 2008

As a clinical research assistant (CRA) in the 1990s, Darren McDaniel didn’t like what he saw when it came to institutional review boards (IRBs). From what he witnessed, sponsors had two…more...

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Stopping Traffic

Coast IRB’s DIA Psychic

June 27, 2008

It’s hard to compete with 540-plus exhibitor booths for the attention of 8,000-plus people meandering around. Actually, it’s way beyond hard. But a few companies at this year’s Drug Information Association (DIA) conference in Boston managed to captivate us. Chief among them: the standard-sized booth of Coast Independent Review Board (IRB). The Colorado Springs, CO-based IRB hired…more...

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Sites, IRBs, CROs Lining Up

Seeking The AAHRPP Seal

May 19, 2008

Independent accreditation in the clinical research world had been slow to catch on, but now it suddenly appears to be a topic of high interest. Compliance with existing regulations is not enough, it seems. Just take the numbers. In its first seven years of accrediting those in clinical research, the Association for the Accreditation of Human Research…more...

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IND Ethics Loophole

Circare: Academic Patient Advocate

April 21, 2008

Every other day, Adil Shamoo says he gets an inquiry about something untoward in a clinical trial. Shamoo, whose day job is professor of molecular biology, epidemiology and preventive medicine at the University of Maryland’s School of Medicine, is also the founder of Citizens for Responsible Care and Research (CIRCARE). CIRCARE is an advocacy organization for anyone…more...

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Harvard Prof On Stats Shifts

Pssst! Need To Change An End Point?

February 07, 2008

Not long ago, on a bleak winter morning when the U.S. Congress and the New York governor and the Connecticut attorney general and the second most important medical journal were trashing the industry, we banged out an email to Scott Evans. He’s a senior research scientist in Harvard University’s School of Public Health. He teaches biostatistics there,…more...

Military PIs and Populations

Military Medical Foundations

Non-profit military medical foundations connect the private sector with principal investigators and test subjects all over the world.

EDC + CDMS, CTMS

MedNet: Managing the Whole Trial

Minneapolis’s MedNet Solutions offers low-cost electronic data capture and a platform that manages investigator payments, regulatory documents and clinical data. The company’s Tim Pratt explains what sets the firm apart.

Avandia, etrials, FDA on e-CRFs

News Briefs

News for Tuesday, May 22.


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