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Compliance In Focus
Posted by John Lehmann on Thu, May 24, 2012

Why Good Clinical Practice is So Important

report from the Institute of Medicine (IOM) was based on a workshop held with this focus: “PublicTuskegee Syphilis study Engagement and Clinical Trials.” In this report, IOM draws attention to the fact that many clinical trials are slow to enroll patients, and some studies never reach their recruitment number goal.

Advances in the field of medicine are dependent on the quality of research that is conducted. As the report points out, “Clinical trails are the linking step that enables basic research findings to emerge at the patient’s bed-side and the physicians’ examining rooms. The questions clinical trials seek to answer change over time, depending on advances in basic research and the population health problems they are intended to address. Potential new treatments must be tested in humans in order to find out whether they succeed and whether they cause harm.”

Unfortunately, some of the public’s opinion of clinical trials, or “human research,” has been influenced by a haunting past. From the Tuskegee Syphilis study to the Ketek trial, these are examples of serious research misconduct. No person wants to be seen as a “means to an end.” Could these trials have a lingering effect on the public’s trust of the research industry as a whole?

This is why Good Clinical Practice is so important. Yes, most investigational treatments must go through clinical trials, but each study team should have a mind-set that is absolutely essential to protect patients’ rights and assure data integrity. Take the time to download and read IMARC’s whitepaper on GCP and better understand the process of Good Clinical Practice.

Please share your thoughts on steps our industry can take to engage the public in clinical trials.

 Photo Credit: Kheel

Topics: Good Clinical Practice, Tuskegee Syphilis Study, Ketek Trial

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