From The Editor | November 18, 2011

Want To Increase Clinical Trial Participation?

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By Rob Wright, Chief Editor, Life Science Leader magazine

I recently read an article about drug companies paying hospitals to mine their databases for potential clinical trial participants. Apparently, drug companies, including Pfizer (NYSE: PFE), are willing to pay somewhere between $50,000 to $200,000 per list of patients qualifying for drugmaker clinical trials. At various conferences I have attended throughout the year, one of the challenges consistently raised by pharmaceutical and biotech companies has been patient enrollment in clinical trials. For example, at BIO International in Washington D.C., I attended the diversity summit and listened to experts discuss how clinical trials continue to underrepresent various races and ethnicity. According to August White, M.D., professor of orthopedic surgery at Harvard Medical School, certain groups continue to receive disparate care in the United States. This is but one of the reasons for less than desirable clinical trial enrollment numbers. So what are some of the solutions to this dilemma?

Solutions To Improve Clinical Trial Enrollment
Pharma companies demonstrating a willingness to pay for lists is just one of the recent solutions. This past year, I have heard several excellent, yet very simple ideas for improving enrollment in clinical trials. For example, one speaker discussed the importance of just thanking a patient after they have participated in the clinical trial and sharing the results with them directly via "lay summaries" rather than expecting them to go to medical journals they don't have access to and most wouldn't understand. By thanking and helping participants to understand the results, perhaps they will be more inclined to participate in a future study or convince friends and family members to do so. Another simple suggestion is for companies to partner with patient advocate organizations that target the various diseases pharma companies are focusing on for drug development. A more involved approach has been the evolution of virtual clinical trials which allows for patients to self-report information and decrease the frequency with which they need to physically visit a healthcare provider. One obvious solution, however, continues to receive minimal attention.

Self-Selection
A reader recently wrote to me about a patient recruitment business she stumbled upon (www.mytrus.com). The idea, which seems so commonsensical, is to have patients self-select which clinical trials in which they would like to enroll. The big idea, according to the Mytrus website, is to empower participants and physicians by making clinical trials more accessible and convenient; and by entrusting participants with their individual trial results. Steve Cummings, M.D., CEO and chairman of the board for Mytrus, believes people can safely participate in clinical trials from the convenience of their own homes. Other benefits include improving generalizability of results, better education of patients on details of study participation, and consistency of messaging to patients. Getting started involves four steps – find a trial that interests you, see if you qualify, agree to the study requirements, and participate. What a great, yet simple concept. Apparently, not so simple, as the method for conducting clinical trials over the Internet was patented by Boston University (BU) and purchased by Mytrus, which will have exclusive rights until the patent expires in 2017. Personally, I love this idea, and would like to thank Tim McAlindon and Karim Kabbara for their work in developing this intellectually property while working at BU. The only question I have is — did BU reward these researchers with a piece of the action — as details of the purchase price went undisclosed in the various press releases?