Clinical trial news

CEOs save time, money with clearer trial contracts

Maureen Martino — Fri, 10 Oct 2008 10:31:50 -0400

A group of CEOs is hoping to save companies time and money by improving the legal contracts required to initiate cancer trials. Founded in 2001, the CEO Roundtable on Cancer is a nonprofit group that seeks to eliminate cancer as a public health threat.

Research has shown that the clinical trial contract negotiation phase can take as many as 300 days, stretching out development time and wasting millions of dollars in legal fees and other expenses. The Round able worked with the National Cancer institute to study legal concepts and provision common in many trial contracts, and drafted a universal template based on the criteria most company use. "The group hopes to shorten the drug testing process by making available 'common language' for clinical trial contracts through a set of standardized contract templates for use by NCI-designated cancer centers and the pharmaceutical industry," the group said in a statement.

Use of the template is, of course, voluntary. But the group believes that the standardized contract can cut contract negotiation time down from a median of 172 day to just 30 days.

- see this release

Pipex acquires mid-stage RA program

John Carroll — Tue, 19 Aug 2008 12:15:27 -0400

Pipex Pharmaceuticals has acquired oral dnaJP1, a once-daily candidate for the treatment of rheumatoid arthritis which has completed a 160 patient Phase II clinical trial for the treatment of rheumatoid arthritis.

"Oral dnaJP1 certainly complements our existing clinical stage immunology programs which include TRIMESTA, our oral phase II/III clinical program in multiple sclerosis and our CD4 inhibitor technology," said Pipex CEO Nicholas Stergis. "We have been equally impressed with the rigor and quality of the scientific data, along with the level of grant funding this program has received over the years from the NIH. We look forward to reporting additional clinical data from this study later this year."

--read the Pipex release

Big Pharma pulls out of U.K. trials

Maureen Martino — Fri, 27 Jun 2008 09:27:44 -0400

There's more bad news today for the U.K.'s drug development industry. Pfizer, Roche and Merck Serono have all decided to cut back on clinical research there, according to the Financial Times. The problem, companies say, is that too few U.K. patients are receiving cutting-edge drugs like Avasin and Erbitux, making it difficult for experimental therapies to be tested against patients already on those drugs. Just yesterday the U.K.'s National Institute for Clinical Health and Excellence advised against the use of Avastin and Erbitux. The Association of the British Pharmaceutical Industry recently found that, 20 trials at just four companies didn't happen because of difficulty recruiting patients. "In the long-term there is a serious risk that if we get to the point where none of the new drugs are being used in the U.K., the trials won't be done here," said Harpal Kumar, head of Cancer Research UK.

- read the Financial Times article

EmergingMed matches patients with clinical trials

Wed, 14 May 2008 06:59:55 -0400

Recruiting the right number of the right patients for any clinical trial can be a tough prospect. Now there are a host of new efforts to match a patient with a clinical trial, including a service offered by the for-profit company EmergingMed. Analysts note that only about a quarter of the 200,000 eligible U.S. patients diagnosed with cancer participate in clinical trials each year. And while there are a number of reasons cited, the primary cause appears to be simple ignorance about what's going on.

The Wall Street Journal notes that there are a number of new outreach efforts that are being launched, but one of the most intriguing is operated by EmergingMed, which helps coordinate a patient's search for the right trial.

"We need to explain to the American public that the drugs we are benefiting from today did not come out of thin air," says Armin Weinberg, director of Baylor College of Medicine's Chronic Disease Prevention and Control Research Center in Houston. "Their participation in trials is the thing that is going to help us advance in all these battles against cancer, asthma, diabetes and hypertension."

- check out this release on the matching service
- read the article from the Wall Street Journal

Duke, FDA join forces to overhaul clinical trials

Wed, 21 Nov 2007 06:59:57 -0500

Drug developers typically plunk down about $500 million for a clinical outcomes trial, says Robert Calif, vice chancellor for clinical research at Duke University, and much of that money is simply wasted. So Duke and the FDA are collaborating on a sweeping review of the whole trial process, looking for ways to eliminate waste and increase efficiency. Everything is on the table, including a look at more efficient use of electronic records, an accreditation process for researchers and even the review boards charged with protecting patients.

- read the report from the Wall Street Journal's health blog

New tests planned after Parkinson's drug fails trial

Wed, 22 Aug 2007 06:59:58 -0400

Merck KGaA and its development partner, Newron, say that a late-stage study of their experimental therapy for Parkinson's failed to demonstrate any significant effect. But the two developers refuse to walk away from safinamide. Researchers are planning to mount new trials with lower doses to find the right formula.

"The primary endpoint, time to intervention, did not reach statistical significance when data from both safinamide dose groups were pooled," the companies said, after reviewing 18 months of combined data from patients taking the 50-100 mg and 120-200 mg doses. But researchers said that a lack of response among patients taking the highest dose could have skewed the data. Adding safinamide to dopamine agonist therapy at 50-100 mg daily could delay the time to therapeutic adjustment.

- see the release on the trial data
- read the AFX report

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Serono licenses Newron Parkinson's therapy. Report