Wednesday, October 6, 2010

Clinical Trials: Is Full Disclosure Necessary?

Here’s a hypothetical: Your 85-year-old mother, who has Alzheimer’s, has the chance to enter into a clinical trial for a new Alzheimer's disease drug. Possible dilemma: The type of drug your mother will receive is similar to one that just failed in another trial – in fact, it caused harm. Do you want to know about that failed trial? Is the trial sponsor under any obligation to tell you about it?

The New York Times, which recently discussed the pros and cons concerning full disclosure in clinical trials, said Alzheimer's disease patients and their caregivers may be different than other patients. Cancer patients may want to know all details if a trial is stopped; Alzheimer's disease caregivers, too tired from the daily grind, may not. Certainly, we’re talking about different diseases here: People can survive some cancers. For Alzheimer's disease, there is no cure.

The basis for the article was Eli Lilly’s decision to stop its huge trial on semagacestat because patients showed worse cognitive functioning than those on placebo, and increased skin cancer risk. According to the article, Lilly's drug disrupted gamma secretase, but was an older generation of this drug class. The newer disrupters, the article said, may be safer.

Of course, trial participants sign consent forms. They acknowledge that the drug may not help; there may be side effects; they may not get better -- or even worse. But our point is that industry members could help themselves in the court of public opinion if they take a few more steps to notify trial participants about why a trial was canceled. Leaving this to the clinic that recruited the patient initially is one of its responsibilities, but it should not fall just on that clinic.We encourage industry to consider this approach as a way to invest in its depleted "trust" bank account with patients. 

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