Providing patients with promising experimental therapy or ruining clinical trials?

Posted on October 31, 2009
Filed Under Bioethics, Drug & Device |

Ninety percent of clinicians in a recent online survey believed that ignoring certain entry criteria for clinical trials was acceptable if the clinician believes that the patient will benefit from the trial. A number of clinicians described under what circumstances they would bend the rules. Downplaying a substance abuse history, altering medical records, and artificially improving an otherwise poor kidney function test are all examples of protocol violations that some clinicians found acceptable under the right circumstances.

All of the protocol violations were presumably made because the doctors felt that they were acting in the best interests of their individual patients. However, the purpose of clinical trials is not to improve the outcomes of individual patients, they are to determine the safety and effectiveness of an experimental drug or treatment. (To learn more about clinical trials see clinicaltrials.gov)

What does this mean for clinical trials? Do researchers need to focus on improving clinical trial designs so that clinicians do not feel conflicted between their commitment to their patient and the research? If so many clinicians seem willing to break protocol, can the results of the trials even be trusted?

The New York Times, October 29, 2009.

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