Study Conduct

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.

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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.

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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.

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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.

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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.

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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.

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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.

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Study shows value in social media

Monday, April 25, 2011 12:23 PM

A clinical trial of 596 patients testing whether lithium would slow the progression of Lou Gehrig's disease, also known as amyotrophic lateral sclerosis (ALS), did not have positive results.  However, the findings did show that the use of a social network to enroll patients and report and collect data may be useful for future studies, according to The Wall Street Journal.

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China: a quick and cost-efficient direction for drug development

Monday, April 25, 2011 12:12 PM

U.S. companies seeking to conduct clinical trials of new drugs and medical devices, Dr. R. Stephen Porter of Tennessee says China provides a lower-cost setting in which jobs can be accomplished more quickly, according to The Tennessean.

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Streamlining IRB approval process yields dramatic results in turnaround time for University of Maryland

Monday, April 25, 2011 08:02 AM

Last March it took 35 days for a full Institutional Review Board (IRB) approval for a clinical trial from the University of Maryland’s School of Medicine, which reviews more than 1,000 applications annually. This March, IRB approval time dropped to 21 days, and just 13 days in February.

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