Clinical Trials — hope and frustration as barriers to enrollment persist

Since I began working in Oncology over 20 years ago, we have been discussing the challenges around recruiting adult patients into cancer clinical trials. Even after numerous efforts and multi-million dollar investments, the rate of enrollment has remained flat — around 3–5%. As we are witnessing exponential progress in the treatment of cancer, increasing enrollment in trials is more important than ever. Yet, many of the same barriers still remain.

A couple weeks ago, I was privileged to attend an advisory board of lung cancer patients sharing their experiences, challenges and insights. Part of the discussion centered around clinical trials. When asked — “Before being diagnosed with cancer, how many of you thought all cancer clinical treatment trials included a placebo?” — almost every hand in the room shot up. This is a common misconception among cancer patients. Patients also believe that one should not consider a trial until all other treatment options have failed — which is also untrue. It is imperative that we continue to educate patients about clinical trials as treatment options and help with myth busting so that patients understand the facts and are raising questions with their doctors about trials.

At the Cancer Support Community, we have developed a series of award-winning tools and educational materials called Frankly Speaking About Cancer Clinical Trials in both English and Spanish to help patients better understand trials and prepare for a discussion with their doctor.

And it is critical that we address the availability of trials in the community setting. While more than 80% of cancer patients are being treated for cancer in the community, there continues to be limited availability of trials in community hospitals and practices. The majority of trials are still offered only in large academic institutions.

All of this got me thinking — how can we learn more about what some community practices are doing well and then use those lessons to design clinical trial programs that recruit and retain a higher percentage of patients? I had the chance to talk to practices in Pennsylvania, South Dakota, and Texas that have well-above average enrollment in clinical trials and have done so through a combination of efforts including:

• Making clinical trials a priority across the organization
• Identifying a site champion or champions to beat the drum about trials
• Educating patients about trials and holding their hands through what can be an overwhelming and scary process
• Investing in training clinical and other staff — especially nurses — and elevating them as core members of the clinical trials teams
• Focusing on trial designs that are more patient-friendly
• Utilizing technology to remotely monitor and check in with patients

The stakes couldn’t be higher as potentially game-changing treatments are being developed. Clinical trials are a critical part of the drug-development process, moving exciting new treatments from the laboratory to testing their safety and efficacy in people. According to an article published in Contemporary Clinical Trials Communications in which patient enrollment is discussed, 25% of cancer trials were unable to enroll enough patients and a total of 20% of trials did not reach completion between 2005 and 2011. Furthermore, the article reports that 40% of trials sponsored by the National Cancer Institute failed to be completed.

There are multiple factors that might result in closing a clinical trial prematurely, including how patients are invited to participate, patient enrollment, and retention. When a clinical trial is closed early for reasons other than poor safety or efficacy, patients lose the opportunity of access to possibly life-saving treatments.

Instead of saying we can’t do this — it’s too hard, it’s too expensive, it’s too demanding — I believe we need to take a page out of the book of some of the more successful practices and determine what can be replicated in other practices and other parts of the country. There is much to learn — and much to do — and the issue is too important not take a harder look and learn from others in the field.