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.


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  • http://www.MDWhistleblower.blogspot.com Michael Kirsch, M.D.

    I don’t give the doctor a free pass on gaming the system, despite intentions to help an individual patient. First, by compromising the study, it hurts many patients. The practice would also lessen trust between us and the public. Finally, if we begin to sacrifice our personal integrity, then this will lead to other practices of questionable propriety that we will justify to assist a particular patient. It would be a short leap to start engaging in ‘creative coding’ or stretching some diagnoses so that insurance would cover a condition or test. Every day we physicians face ethical challenges. Sure, it can be a struggle at times, and we may not prevail every time. But, we should not surrender what sets us apart from many other stakeholders in the system.

  • http://www.spineatopia.com Dr. Jason

    Wow… The topic of ethics? That’s a tough one since so many people and doctors alike have a very wide range of what they think is ethical.

    I am not an MD and don’t prescribe medications, but the one thing that has always bothered me was using medications off-label. Many psychotropic drugs are used on age groups they were never intended for, or tested for. Many medications are used off-label because it was found to have some therapeutic value to it.

    Using medications off-label seems to be a risky practice considering we don’t now the full consequence of the side effects. Simply put, it a medication is going to be tested on a certain age group and demographic then it should be used on that demographic only.

    Medications aren’t benign chemicals we inject into the body and should be given with more precaution.

    Thanks for the great post Doc.

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