Without clinical trials, cancer treatment would always remain the same. In contrast to the situation for children with cancer, for whom clinical trial participation is a de facto standard of care, only three to five percent of adults with cancer ever participate in a clinical trial. Never have we had more therapeutic targets and more ideas emerging from the laboratories. This bounty will grow even faster as data from large-scale projects, such as the Cancer Genome Atlas project, become available. But if we don't improve our ability to attract volunteers to participate in clinical trials, we will have the knowledge but not the means to create a new reality for cancer patients.
The emerging era of genomically driven, personalized medicine amplifies the need to focus on clinical trial participation. As we recognize the heterogeneity of human cancer, clinical trials are increasingly likely to seek volunteers who not only have a particular cancer at a particular point in the course of the disease, but they will also need to have a particular molecular defect that drives the cancer. That is good news. Therapies will get more specific, more targeted, more personalized, and as a result, more effective. But at the same time, we will struggle to advance these trials if we start with only three percent of patients and then subdivide them by tumor genotype into many subsets. To succeed in the emerging era of personalized oncology, we will need to engage a greater proportion of cancer patients in research-driven care.
As individual oncologists, we can't solve this problem on our own, but there is much we can do. So why is participation of adults with cancer in clinical trials so low?
Let's start with reflecting on physician-specific barriers. The NCI tells us that there are significant physician barriers including: lack of awareness of appropriate clinical trials, unwillingness to “lose control” of a patient's care, belief that standard therapy is best, belief that referring and/or participating in a clinical trial adds an administrative burden, and concerns about the person's care or how the person will react to the suggestion of clinical trial participation.
While these concerns can be valid in some situations, often they can be overcome and physician barriers to clinical trial participation can be lowered substantially. We would do well to reflect on where each of us stands on this issue.
Many barriers also reside with the patient. According to the NCI, the main barriers on the patient side include: lack of awareness of clinical trials, lack of access to trials, fear, distrust, suspicions of research, practical or personal obstacles, perceived or actual insurance or cost challenges, and unwillingness to go against a personal physician's wishes. Additional barriers exist for underserved populations.
A survey of nearly 6,000 people with cancer conducted in 2000 illustrated some of these barriers and also pointed to opportunities. About 85 percent of people with cancer were either unaware or unsure that participation in clinical trials was an option, though about 75 percent of these people said they would have been willing to enroll had they known it was possible. Of those who were aware of the clinical trial option, most declined to participate partly because they believed common myths about clinical trials.
There was good news as well. People who chose to participate in clinical trials found the experience to be quite positive. A total of 97 percent indicated that they were treated with dignity and respect and that the quality of care they received was “excellent” or “good,” and 86 percent indicated that their care was covered by insurance.
Since the survey was conducted, many states have passed laws requiring that routine costs of care for participants in clinical trials be covered, and Medicare has continued to support such costs.
With most of the patient-side barriers centered on deficits in knowledge and misconceptions, this oncologist is trying to do something about it. I've had the opportunity to team up with a cancer survivor and clinical trial participant to author a book entitled Cancer Clinical Trials, A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials. Written for people living with cancer and their friends and families, the book demystifies the clinical research process, helps cancer patients decide if clinical trials might be right for them, find and choose a clinical trial, and navigate and understand the experience of being a participant in clinical research.
As is fitting for the modern era, authors are now expected to do more than just write the book. The book must now be accompanied by a blog and a presence in social media outlets. So what started as a book has grown into an ongoing effort to spread knowledge and help folks gain comfort with clinical trials using printed media, a blog, Facebook, Twitter, Google+ and other social media.
Our blog is at www.cancer-clinical-trials.com. It's been a great experience and even allowed us to have some fun with the serious issues, thanks to my writing partner's talent for cartooning—for example, shown here is his take on clinical trial participation.
While taking a sabbatical to write a book is a luxury (for which I am very grateful to my colleagues who made it possible) that most of us don't have, all of us oncologists can do something reduce our patients' anxiety and increase their knowledge about clinical trials.