Bob Millham, Executive Vice President of Clinical Development and Head of Oncology Center of Excellence, Syneos Health™
Today is World Cancer Day and this year’s theme, “I Am and I Will” sends a strong message about personal empowerment. It is up to each and every one of us to support research and development of potential new cancer therapies that can change patients’ lives, whether we are involved in cancer research in some way or affected by cancer ourselves or through someone we love.
One crucial way we can do this is by working hard to improve the participation of patients in oncology clinical trials – and letting them know how important they are. According to TrialTrove, Informa’s Pharma Intelligence clinical trials database, right now there are over 65,000 oncology trials registered worldwide. Approximately 33,000 sponsors (including hospitals and other cancer research institutions) are investigating more than 5,000 different cancer therapies. That’s a lot of research! But it raises a critical question – where are the trial participants coming from to support all that research? Currently, less than 5% of patients treated for cancer participate in clinical trials – even as a vast majority of cancer patients report being very inclined or willing to participate.
Right now, there are currently 23,000 clinical trials ongoing for immuno-oncology drugs alone, an exciting area of research where some of the biggest advances are now being made. But those trials almost without exception take longer than expected and almost all of that delay can be attributed to challenges in patient recruitment.
Obstacles to participation are legion and well-documented. They include informational and logistical barriers, age (patients over 65 participate in clinical trials at well below the expected rate), and the availability of clinical trials appropriate to a patient’s own histology, stage, biomarker status and other individual characteristics. The latter is especially the case as targeted therapies are tailored to ever-smaller subsets of patients.
Other obstacles involve factors that better communication and engagement with patients could address. Patients often cite fear of adverse events and whether they will be assigned to the placebo or control group as barriers. They may not see potential benefits to their participation, whether for themselves (such as access to a potential new therapy or a research team dedicated to their care) or for the patients who will come after them.
As we recognize World Cancer Day this year, one sure way we can accelerate cancer research is to increase our focus on the pivotal role of the patient. We can collaborate with patient advocates to better educate patients, their families and the general public about options and opportunities for clinical trial participation, as well as the pros and cons. It is especially important that we help promote sources of credible information, so that patients and their loved ones can better navigate a complex research and treatment landscape and be their own best advocates.
In addition, we need to align with important initiatives underway to re-think the classic design of clinical trials (e.g. early markers of long-term benefit, such as relevant changes in the tumor microenvironment and circulating cytokines) and patient selection/eligibility criteria so more patients qualify for participation and our results are more meaningful.
Last but not least, reports from focus groups of cancer patients make clear that all of us involved in cancer research -- from sponsors and research organizations to investigators and site staff -- have work to do to help patients feel more comfortable with the clinical trial process, manage their expectations and communicate results – in other words, to engage them more fully as partners in our work. As a recent editorial in the journal Nature makes clear, one of the best solutions to this complex problem may also be one of the simplest – ensuring that patients and families who participate in oncology clinical trials always know how much their contribution is appreciated and valued by saying “thank you!” – not only on World Cancer Day, but every day.
For more perspective, tune in to my podcast, Episode 028: World Cancer Day, of the Syneos Health Podcast Series.
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