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October 12, 2008
Database Finds 150K Patients
In Silico Studies By i3 Innovus
The health outcomes division of the i3 brand discusses trials that are professionally designed and run on the computer.
IND Ethics Loophole
Circare: Academic Patient Advocate
University of Maryland physicist Adil Shamoo, founder of CIRCARE, says there are gaps in existing law that leave patients exposed.
Shark Repellent
Empirica From Phase Forward
A new name for the safety products from Phase Forward, plus insights into faster responses to safety crises.
A-List Of Speakers At Harvard
Post-Approval? Or Pre-Apocalypse?
With Mark McClellan and Janet Woodcock on the agenda, the Outcome meeting will be another illuminating event this year.
Strategies from Wyeth, Actelion & Pfizer
CTC 2008: Proactive Risk Abatement
A report from the Clinical Trials Congress about risk. One message: start a regulatory conversation early. And consult your preclinical team.
Sentrx, a leading provider of drug safety services, issued a press release noting that the company doubled the number of biopharmaceutical companies it serves. The company handles data concerning 30,000 adverse events annually. Its technology toolbox includes web-based ways to manage drug safety. Sentrx began offering adverse event case processing… more...
A leading cardiologist at the Cleveland Clinic, Steve Nissen, is charging that the NIH had a panic attack and should have allowed the ADAPT trial to continue. The ADAPT trial, for the newcomers, was the Alzheimer’s Disease Anti-Inflammatory Prevention Trial. It was halted in December 2004 after similar trials of… more...
Late last week, DataTrak International reported a burst of new business from unspecified customers in the U.S. and Europe. In total, 18 new trials will use its eClinical suite. DataTrak is positioning that system as an enterprise-wide solution for clinical trials. Our own visit to the suburban Cleveland offices of… more...
In days of yore—say, eight or nine years ago—adverse events were the province of experts. Back in the day, the main question was, “Are we seeing a safety signal?” or “What will the FDA say?” Safety data, during clinical trials and after a drug’s approval, were carefully analyzed over a… more...
As ClinPage reported recently, Dana-Farber Harvard Cancer Center has been using Phase Forward’s InForm software for clinical trials for a while. But only since the summer of 2006 has the academic medical center embarked on using electronic data capture (EDC) for its largest and most complex trial, a 500-patient study… more...
The New York Times charges that Eli Lilly has spent years hiding diabetes and weight gain associated with Zyprexa, a $4.2 billion drug for schizophrenia. The newspaper says it has gained access to “hundreds” of Lilly emails and company documents from a lawyer suing the company. Here’s a quote from… more...
Yola Moride will serve the EMEA as a national expert at the EMEA’s London offices. She’s a bigshot. Moride was recently voted president-elect of The International Society for Pharmacoepidemiology (ISPE). She holds appointments as Adjunct Professor at McGill University, Visiting Professor at the University of Bordeaux, and as Project Director… more...
A new database made its debut this week, with little U.S. fanfare. EMEA Executive Director Thomas Lönngren said of the EudraPharm resource: “Once fully developed, this database will be the reference point for independent information about all medicines available to Europeans, no matter whether these medicines have been authorised at… more...
Ted Agres of The Scientist has a very nice review of the recent machinations around drug safety. The article is an attempt to predict what will happen when the new Congress convenes. The article suggests that details of a new drug safety environment are being worked out behind the scenes.… more...
Amgen says it is trying to rebut idle misinformation and gossip about the safety of a blockbuster product. Specifically, without mentioning the publication, it is angry about the fallout in response to research published in the New England Journal of Medicine in mid-November. Doctors are noticing that two clinical trials,… more...
