Poll: Changing clinical study entry criteria to include terminal patients

When it comes to terminal disease, experimental therapies can be a patient’s last hope.

Should physicians try to bend the entry criteria of clinical studies to include these often desperate patients?

A recent study from the University of Massachusetts medical school revealed that 90 percent of physicians would ignore the entry guidelines for a study if they felt that it would benefit the patient.

The New York Times cited examples ranging from “altering medical records in order to get a patient into an HIV treatment trial, to downplaying a substance abuse history in order to help a patientenroll in a trial on depression.”

But not every clinical trial succeeds. Very few experimental medications are better than standard therapy, and sometimes they’re worse.

Patients who may otherwise not qualify for an experimental drug study can tarnish, or even negate, the findings. Nobody can then benefit from the potential of an investigational drug.

Doctors often have to make difficult choices between duty to the patient and a study’s integrity. Although the importance of adhering to strict entry criteria needs to be stressed, clinical investigators also should understand the difficult position doctors are often in, and design their clinical protocols clearly enough to minimize these dilemmas.

Likewise, we need to continue debating whether alternative approaches such as “compassionate use” and “off-protocol” treatments should have a place in clinical trials.

I encourage you to listen and vote in this week’s poll, located both below, and in the upper right column of the blog.