Top Stories for the Week of August 28th 2006

Cultivate Your Clinical Researchers, Pharma

Posted by: Sara Gambrill
 
Pharma companies know they have to reach out to new and inexperienced investigators to maintain capacity for growth in emerging regions. Investigator capacity is a major issue in these markets because they have experienced such significant growth in recent years. In the U.S., though, companies have taken more of a sink-or-swim approach when introducing physicians to clinical research, and they could be making a big mistake.

In the U.S. new sites are often given a chance to participate in clinical trials through competitive enrollment. If they meet patient numbers by a deadline, then they participate. If not, they waste a lot of time and energy for nothing, because often they don’t get a second shot at it.

Top Stories for the Week of August 21th 2006

The Name Game

Posted by: Steve Zisson

It’s a call I made in January. So what took SFBC so long to decide to change its name to PharmaNet? While the move took a little longer than expected, it is another sign that new CEO Jeffrey McMullen and his PharmaNet-ters still have a solid chance to turnaround the troubled former SFBC.

Thomson CenterWatch has known that the PharmaNet name has a lot of positive brand equity. It has been a top performer among contract research organizations in the Thomson CenterWatch Survey of Investigative Sites in the US for 2005 and 2003. It was also top-rated in Europe in 2004.

Prisoners As Study "Volunteers"

Posted by: Sara Gambrill

A recent Institute of Medicine Report has recommended that drug testing be allowed on prisoners, thereby lifting a decades-old ban on this practice. The recommendation is drawing both criticism and support from government and industry.

I don’t think that recruiting prisoners to test experimental drugs is a good idea.

The Nuremberg Code is the cornerstone on which all regulations governing clinical research are based. This is a 10-point code that describes the basic principles of ethical behavior in the conduct of human experimentation. The code was written by judges who had presided over the “Nazi Doctors Trial” for which 20 physicians, all members of the Nazi Party, were charged with murder, torture and other atrocities committed in the name of medical science...

Top Stories for the Week of August 14th 2006

SFBC Now PharmaNet Development Group

Posted by: Stephen DeSantis

Now just emerging from a year of legal and financial blows and bad publicity,SFBC has decided to change its name to PharmaNet Development Group, pending shareholder approval later this month. The company’s late stage division will continue to be called PharmaNet, and its early stage divisions will operate under the names Anapharm and Taylor Technology.

SFBC’s second quarter shows how this difficult year has affected the company’s balance sheet. Showing signs that the worst may be behind them, the company reported strong growth ahead with a total backlog of anticipated direct revenue of $353.5 million.

To read the full articles for this issue or for more information on these and other breaking stories, please click here!

Is India Ready For Phase I Studies?

Posted by: Sara Gambrill

India has come a long way as a center for clinical drug trials, but is the country ready for Phase I studies? I think the short answer - and others would agree - is “no”. Take, for instance, recent comments by Ashwini Kumar, the Drug Controller General of India (DCGI), who spoke recently at the Drug Information Association’s (DIA) Annual Meeting in Philadelphia. Kumar, head of the Central Drug Standard Control Organization (CDSCO), India’s regulatory agency, said that India needed to create an environment for the best quality assurance before embarking on phase I studies...

CenterWatch Monthly: August 2006 Issue

The Right To Use Unproven Treatments?

Posted by: Sara Gambrill

It’s ironic that at a time when several high-profile marketed drugs have been given a black box warning or withdrawn from the market that the Abigail Alliance has gathered steam.

The Abigail Alliance is a patient advocacy group that is suing the U.S. Food and Drug Administration for the patients’ “right” to take an experimental drug after it has been through only one phase of drug development. Two members of the three-judge panel of the U.S. Court of Appeals for the D.C. Circuit found that patients with a life-threatening and otherwise untreatable disease have a constitutional right to seek experimental treatments, even if researchers have not determined efficacy. In addition, the court said that the government should be removed from the equation unless it has a “compelling interest.”

Top Stories for the Week of August 7th, 2006

Trial Registries Proliferate: Is Anyone Benefiting?

Posted by: Dan McDonald

The issue of clinical trial result transparency continues to evolve at a rapid pace. During the past few years, almost every stakeholder has taken action in some form.  This should be a positive development because there is a lot attention being focused on a very important issue. But at the end of the day, have we made a difference? Has the noise that this caused just confused the issue more for patients and physicians, or made finding trial information easier and more useful?

The fact is patients today have to navigate a world of disparate databases with listings written in difficult medical terminology and formatted in different ways in order to find trial information. The creation of some clinical trial search engines might help the patient find trials faster, but the search results simply link you to the different registries so the same problem remains. The industry has spent nearly $100 million during the past 24 months to respond to the outcry from advocacy groups, government agencies and professional associations to be more transparent with information about their active and completed clinical trials. But, are we any better off as a result?