Study Conduct

Quintiles’ Chasse, Sanofi Pasteur’s Milam make unprecedented industry move to the site world

Monday, May 23, 2011 08:44 AM

Christine Pierre, president of the investigator site group and consultancy RxTrials, shocked parts of the industry this month when she hired Adam Chasse away from global CRO Quintiles and Dan Milam from Sanofi Pasteur, the largest company in the world devoted to vaccines.

More... »

Perceptive survey shows most CRAs use a CTMS

Friday, May 20, 2011 11:00 AM

Perceptive Informatics, an eClinical solutions provider and a subsidiary of Parexel, has results of a global survey conducted during its webinar entitled "Critical Tasks of Site Monitors: Using a CTMS to Improve Efficiency."

More... »

Leukemia charity invests $3.7 million for trial network

Thursday, May 19, 2011 10:42 AM

Leukemia & Lymphoma Research, a U.K. charity, is investing $3.7 million in a national network of clinical trial centers to improve chances of survival for people suffering from leukaemia, lymphoma and myeloma.

More... »

Trend shifts from phase I ‘healthy volunteers’

Tuesday, May 17, 2011 11:23 AM

Looking to stretch their research dollars beyond phase I safety determination and catch early glimpses of efficacy, sponsors and CROs are pursuing patient populations to provide those first signs, rather than depending on “healthy volunteers” for safety and then launching phase II trials.

More... »

Trend shifts away from phase I ‘healthy volunteers’

Monday, May 16, 2011 09:35 AM

Looking to stretch their research dollars beyond phase I safety determination and catch early glimpses of efficacy, sponsors and CROs are pursuing patient populations to provide those first signs, rather than depending on “healthy volunteers” for safety and then launching phase II trials.

More... »

CMR analysis finds low phase II success rates

Friday, May 13, 2011 11:30 AM

Within the clinical trial industry, phase II success rates are lower than other stages of drug development and are getting worse, reports an analysis by the U.K.’s Center for Medicines Research (CMR), according to Pharma Times.

More... »

RxTrials hires Adam Chasse as vice president of business development

Wednesday, May 11, 2011 10:17 AM

RxTrials president, Christine Pierre, has named Adam Chasse vice president of business development. Chasse, who has been head of prime sites for Quintiles, will begin immediately and be based in Triangle Park, N.C.

More... »

The economics of off-shoring clinical trials

Monday, May 9, 2011 01:11 PM

The drugs industry insists that the same strict standards apply to foreign trials as to those conducted domestically, according to a Reuters report.

"We have exactly the same protocol and exactly the same standards for our trials around the world,'' says Roche Holding chief executive Severin Schwan.  "Some years ago quality might have been a real concern. Today the situation is different. This is a reason why more trials are being conducted in emerging markets.''

Switzerland-based Roche, the world's largest maker of cancer drugs, is also conducting more trials overseas because the healthcare authorities in certain countries to see data collected from their own populations.

"I see this as an opportunity. A broader range of patients can take part in our trials and the patient population of our trials becomes ethnically more diverse ... If we do not include a certain portion of patients in our global trials, some countries might delay the approval of certain drugs,'' Schwan says.

However, for drug companies looking to globalize clinical trials, two factors are considered: time and money. The clock is always ticking down to the next drug patent expiration, and taking six months off drug development timelines can spell hundreds of millions of dollars of extra sales.

So, many in the industry are still working out just how much cheaper it really is to do clinical research in internationally.

In 2008, former GlaxoSmithKline chief executive Jean-Pierre Garnier published estimates in an article for the Harvard Business Review, stating a midsize company with 60,000 patients in clinical trials could save $600 million a year by switching 50% of its trials to low-cost places such as India and Latin America.

More... »

Point-of-care clinical trials integrate standard trial procedures into routine clinical care

Monday, May 2, 2011 08:00 AM

Doctors at the Veterans Affairs Boston Healthcare System are testing a new clinical trials method that allows researchers to compare the effectiveness of two standard diabetes treatments without spending the cost and time needed to conduct a traditional double-blind, placebo-controlled trial.

More... »

Perceptive’s survey shows increasing interest in adaptive trial designs

Monday, April 25, 2011 12:55 PM

Perceptive Informatics, an eClinical solutions provider and a subsidiary of the Boston-based company Parexel, has results of a global survey conducted during its recent webinar entitled "Implementing Bayesian Response Adaptive Trials." The webinar was attended by over 300 professionals from the biopharmaceutical industry across a broad range of clinical, statistical and regulatory functions. Perceptive polled these professionals about their plans for the implementation of adaptive clinical trial designs.

More... »