Tough Challenges for Clinical Trials

5/5/10

For those of you who, like me, wonder why the cost of getting a drug to market continues to grow each year, here’s what may be a piece of the puzzle: It’s getting harder to do clinical studies.

A report released this morning by the Tufts Center for the Study of Drug Development describes how clinical trials are getting more complex and harder to execute, and how it’s becoming more difficult to recruit and retain patients in these studies.

The report is a follow-up to a 2007 analysis performed by the center. The study looked at over 8,000 protocols from more than 75 pharmaceutical and biotechnology companies.

The report found, among other things, that the median number of procedures in a clinical trial increased by 49 percent, comparing the period of 2000-2003 with 2004-2007. Reflecting the rising complexity of trials, the number of eligibility criteria for entering patients into a study grew by 58 percent over that time, causing fewer patients to enroll in trials (enrollment rates fell 21 percent). Not only that, but it was harder to keep patients in studies because of the large number of procedures, the report said.

The Tufts researchers also found that between 2002 and 2007 trials in oncology, immunology, and central nervous systems indications saw the biggest rise in procedures per trial.

Kenneth Kaitin, director of the center, says the increasing complexity comes from a number of factors, chief among them that the types of products being developed today tend to be geared towards more chronic and challenging indications. “Therefore the trials tend to be more complex,” he says.

The report, however, did not correlate the rise in complexity with any cost figures. How much does an average phase II trial cost today compared to, say, five years ago? How have the costs of a phase III or phase IV study changed? Dr. Kaitin says that as far as he knows there are no studies out there with those kinds of figures. There is an explanation, though: Companies are not very eager to share these numbers. Still, he says he strongly believes the overall increase in complexity goes hand in hand with higher costs.

Sylvia Pagán Westphal is Xconomy's life sciences columnist. You can reach her at swestphal@xconomy.com or you can follow her on Twitter at http://twitter.com/sylviawestphal. Visit http://www.xconomy.com/author/swestphal/ for Sylvia's full bio and disclosures. Follow @

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