Moving the needle on clinical trial recruitment

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Our understanding of disease continues to expand but big hurdles remain to biopharmaceutical development. Among them is the chronic shortage of patient volunteers. There are more than 6,500 cancer clinical trials available yet only 3% of adult patients are participating. The reasons include oncologists not wanting to refer patients away from their practices, reimbursement headaches, and record-keeping and staff requirements.

Then, there's fear. Unfortunately, the tragedies of the past provide some validation. The Tuskegee study (looking at long-term effects of untreated syphilis in African-American men) and the Atomic Energy Commission study (that gave pregnant women radioactive iron but were told it was a “vitamin cocktail”) continued into the 1970s. That's recent history for some of us.

Another barrier is a plain lack of information. It's been reported that 85% of patients and 31% of physicians lack sufficient information about available studies.

For those who were aware of trials, the top reason for refusing to participate was concern over privacy and confidentiality (according to the IOM). A Harris Interactive survey, however, showed that a substantial majority of respondents (70%) agreed that they are “generally satisfied with how their personal health information is handled with regards to privacy protections and security.”

So, where are the gaps?
  1. Clearly, we must keep communicating and educating. Investments must be made in engaging patients and families in a targeted manner.
  2. The process must be made as simple as possible—simple to understand for the patients and simple to administer for the study coordinators. Not slackened, simplified. I have consulted on a number of patient recruitment projects and have told the sponsors on a number of occasions that their study was just too complicated, just too onerous
  3. The “what's in it for me” question must be addressed. What would it take to get more physicians to refer their patients? What incentives need to be changed or created? What can be said to patients so that they better understand their contribution, and feel more connected to the study and its outcome?
We need to look at these issues —including privacy—together to really move the needle.

Paul Oestreicher, PhD, is president, Oestreicher Communications, LLC  Pharmaceuticals

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