Blog Entry: August 5, 2009

The recent article, "Lack of Study Volunteers May Hobble Cancer Fight" by Gina Kolata, discusses the challenge of making progress against cancer in the face of low participation rates among adult cancer patients. However, there are important aspects of this issue that were not sufficiently addressed.

First, the notion that patients are not interested in clinical trials has been refuted. In fact, a 2003 study of American adults by Comis and colleagues in the Journal of Clinical Oncology found that 32% of respondents indicated that they would be very willing to participate in a cancer clinical trial if asked to do so. An earlier study by Comis and colleagues in 2000 highlighted the importance of patient awareness; eighty-five percent of cancer patients surveyed were unaware that clinical trials were a treatment option. Secondly, while trial participation rates are lower among medically underserved populations, this, too, cannot be attributed primarily to disinterest. A recent analysis (Wendler et al) of research studies indicated that minorities may be as willing to participate in research, but are less likely to be asked.

We believe that the principles of social justice demand that all eligible individuals be offered the opportunity to participate in clinical research, ensuring that both the potential benefit and burdens of research participation are shared among all groups. In ENACCT's experience, one way to address this is through ongoing community based education about cancer clinical trials. Enhanced public awareness--before the point of diagnosis and especially among minority communities--may translate to greater acceptability of a clinical trial when it is presented to a patient as an option. We must also help primary care providers understand more about cancer clinical trials, as they can play a valuable role in proactively making early referrals to oncologists that offer cancer clinical trials.

Ms. Kolata also leaves the impression that clinical trials are most appropriate for those who choose it as a last resort. While some cancer patients may be open to joining a trial when other options are no longer feasible, these should not and need not be the only patients who should be the focus of recruitment efforts. Since all patients in phase III trials receive at least standard treatment, cancer clinical trials can be a quality treatment option to many different kinds of patients-even for those receiving their first treatment. 

Finally, the article describes two main options for addressing the challenge of low participation-either offering more incentives for doctors and patients or streamlining studies to result in smaller sample sizes. While we certainly support these ideas, in the communities in which ENACCT has worked, we have found that improving the quality of the patient-provider encounter when discussing the possibility of clinical trial participation is paramount. Clinical trial staff that is well trained in providing culturally competent, patient-centered care can more successfully recruit patients of all backgrounds by adequately addressing the cultural, linguistic, psychosocial and resource needs of the patient as they consider their treatment options. As for the second solution offered, utilization of smaller, later-stage study samples may in fact provide a more efficient means of completing a study, but should nevertheless be considered carefully. Sacrificing more diverse research participation in the name of expediency may result in limited generalizability for the population as a whole.

With recent reports estimating that approximately 40% of NCI's Phase III treatment trials are closing early due to poor accrual, something must be done to change the current paradigm. Improving rates of participation is no doubt a demanding goal, but with greater community engagement, improved health care system infrastructure and sustained commitment by researchers to enhance recruitment strategies, accelerated progress against cancer can be achieved.