American College of Physicians: Internal Medicine — Doctors for Adults ®


Jury is out on truth in clinical trials

From the January ACP Internist, copyright 2009 by the American College of Physicians

Janet Colwell

When researchers announce that an experimental drug has proven so effective as to justify cutting short a clinical trial, headlines scream the news to hopeful patients, who in turn look for guidance from their physicians. The implication is that prolonging the trial is not only unfair to some participating patients but also delays getting a promising new drug to market. However, recent research throws that theory into question: is stopping a trial early for “benefit” good for patients or does it simply shorten the path to FDA approval?

This issue's front page story examines that question in light of studies suggesting that market forces may be at play when trials are stopped early. One review, published last year in Annals of Oncology, analyzed 25 randomized controlled trials and found that more than 85% of the trials stopped in a three-year period were used for FDA registration purposes, suggesting a commercial motivation. The authors point out that repeated interim analyses of data at short intervals should raise suspicion that researchers may be looking to document the statistical significance needed to stop a trial at the expense of valuable, long-term data. Physicians are advised to beware of truncated studies that may inflate a drug's benefits while leaving out other important data on such things as disease recurrence and progression, and adverse events.

Also featured is an update on colorectal cancer screening options. Despite numerous studies showing that colonoscopy is the most effective means of prevention, the test has been slow to catch on with patients. As Ryan DuBosar reports, that's largely due to squeamishness about the exam, which patients try to avoid and doctors often fail to champion. Although guidelines condone other less-uncomfortable options, such as flexible sigmoidoscopy, there are some fairly simple ways to get patients over the initial colonoscopy hurdle, experts advise, including piggybacking it onto other preventive screenings and stepping up patient education. Make sure you couch the bad news with the positive: yes, it does involve the dreaded bowel prep but for most people it happens only once every 10 years.

In other news of note, check out staff writer Stacey Butterfield's coverage of the Medical Group Management Association's annual conference, which includes a story about a family physician in Tucson, Ariz., who is experimenting with Web portals that allow patients to request appointments, refills, referrals or ask questions online.

Many of you have checked out ACP Internist's blog, which continues to gain loyal readers. Look for previews of the latest blog posts each week in our e-newsletter, ACP InternistWeekly. Popular features include live, onsite coverage of medical conferences by our writers; guest postings from other medical bloggers and our own columnists; and weekly humor with Medical News of the Obvious. Please post your comments and let us know what you think.

Janet Colwell


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