CenterWatch Monthly April 2010

Thursday, April 8, 2010 07:52 AM

What’s in a Name? Site Groups in the Post-SMO Era

Site group business models come in almost as many varieties as site groups themselves—with the names to match.

Sites groups today have made clear that they do not want to be lumped into the same category as the big SMOs of the 1990s. In creating different business models, they have contributed to sponsor confusion about how their model works and what they offer. But, more importantly, they have contributed to the survival of investigative sites.

Moving Toward a Patient-Centered Clinical Trial Model

Clinical research is shifting toward greater patient engagement as the biopharmaceutical industry explores new ways to integrate various healthcare trends and technologies that could allow patients to become more actively involved in clinical trials. These trends have the potential to bring about a shift from the industry’s current site-centric model to a more patient-centered model.

Pfizer, for example, is re-examining not only how the company engages patients in its clinical trials and how that process can be improved, but also how patients have become more active in their healthcare decisions and what this trend’s implications are for clinical research.

Michael J. Fox Foundation Gives German IIT New Life

The Michael J. Fox Foundation (MJFF) has awarded $1.1 million to an investigator-initiated collaboration between the German Parkinson Study Group (GPS) and the Parkinson Study Group (PSG) in the U.S. to evaluate the disease-modifying potential of transdermal nicotine on Parkinson’s.

At least 10 centers from each group will help conduct the trial, with potentially two or three more centers from each joining. The study plans to enroll 150 Parkinson’s patients. This trial could serve as a model for future trials involving international groups of sites working together.

Eye On: Addictions

Of the approximately 6 million opioid addicts worldwide, about half are addicted to heroin and other illicit drugs, whereas the other half are addicted to prescription medications including oxycontin, methadone and codeine. Because of the strict regulations involving treatment of opioid addiction with methadone, only a limited number of

facilities are authorized to provide these treatments, and there is a great need for treatments with less potential for abuse and diversion.

According to the U.S. Office of National Drug Control Policy, there are 3 million cocaine users and more than 300,000 methamphetamine users. Cocaine addiction leads 800,000 patients in the U.S. to seek inpatient or outpatient treatment, at a healthcare cost of approximately $30,000 per patient each year and immeasurable negative impact to society.

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January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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