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Compliance In Focus
Posted by Stephani Hulec on Tue, Jun 18, 2013

“Getting More” Clinical Trial Participants

In an article published last week in MedCity News, the author quoted a survey, stating thatGetting More Clinical Trial Participation clinical trials would get more participants if doctors informed their patients about them.

But what, exactly, is meant by doctors “informing” potential patients?  The survey referenced notes that 26% of the U.S. adults polled would be “very likely” participate in a clinical trial if their doctor found a trial and recommended the patient to join.  Furthermore, 46% of the same group polled with be “somewhat likely” to participate in a trial their doctor recommended for them.

However, the article's author notes that only 24% of the public surveyed acknowledged that their doctor or health care professional had ever discussed clinical trials with them, but that 41% agreed that doctors and health care providers have the greatest responsibility in educating the public about participating in such research.  Another observation made is that patients may be more willing to volunteer to participate in a clinical trial if they received the same “admiration” as an organ or blood donor, as clinical trial participants do not typically receive such praise.

From the sponsor’s perspective, much time, energy, and cost goes into training the sites on recruitment, providing materials to be distributed to potential subjects, coming up with site-specific strategies to increase enrollment, etc.  There is a fine line that sponsors and responsible investigators walk between actively recruiting subjects into clinical trials and using inappropriate coercion.  Furthermore, if a person participating in a clinical trial were publicly “admired” in the same way as a blood donor as the article suggests, the patient would be openly disclosing to the public that they have the particular disease or disorder being studied in that trial (aside from the obvious breaches in confidentiality, as noted in the HIPAA Privacy Rule).

As noted in ICH GCP, “the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society” and “freely given informed consent should be obtained from every subject prior to clinical trial participation”.  21 CFR Part 50 also states that “an investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence”.

What is concerning to me is the thought of patient’s physicians recommending that the patient participate in a particular clinical trial.  Of the countless patients throughout the U.S. and beyond, there are many that believe that anything their physician or health care provider recommends for them is the absolute best thing.  Unfortunately for these patients, their voluntary decision whether or not to participate in a clinical trial may be skewed, if their physician’s recommendation is an influence.

As a former research coordinator, I’ve witnessed firsthand when a patient’s respect and adoration for their physician possibly influenced their decision whether or not to participate in a clinical trial.  Yes, most physicians only want what is best for their patients; however, the decision whether or not to be a participant in clinical research should be the patient’s only.

 Let us know your thoughts, comment below!

Photo Credit: Metro Transportation Library and Archive

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Topics: Investigator, Clinical Trial Recruitment, MedCity News


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