Data that are derived from clinical trials help in the development of critical evidence that is necessary to guide patient care for people with cancer. Experts typically endorse this concept, and some practice guidelines have gone so far as to say that the management of patients with cancer can be optimized when conducted in a clinical trial setting.
“Research suggests that only about 3% to 5% of cancer patients in the United States participate in clinical trials, but more participation is needed,” says Matthew D. Galsky, MD. “With few patients participating in trials, the generalizability of the results become questionable.” Poor accrual to clinical trials may also impede the pace of progress when treating particular patients with cancer and could potentially have an impact on the cost of drug development.
Studies have identified several barriers to improving the enrollment of cancer patients into clinical trials, but Dr. Galsky says more research is needed to find interventions that are designed to overcome these hurdles. “Previous research has concentrated on patient awareness of trials and their willingness to participate in them,” he says. “We need to further explore geographic barriers to participation in clinical trials in order to assess availability and access.” He adds that recent survey results suggest that most patients with cancer are not willing to travel significant distances to participate in clinical trials.
A Look at Geographic Accessibility
In a research letter published in JAMA Internal Medicine, Dr. Galsky and colleagues conducted an analysis to estimate the geographic accessibility of clinical trials for advanced cancer in the U.S. Using data derived from ClinicalTrials.gov, the authors reviewed information regarding clinical trials and the associated sites of these trials. They identified all actively accruing trials that evaluated first-line treatments for metastatic breast, prostate, colorectal, and non–small cell lung cancers. The research was limited to these disease-specific sites because they rank among the most commonly diagnosed and most frequent causes of cancer-related mortality in the U.S.
“This is a challenging topic to study because many clinical trials are going simultaneously throughout the country at any given time, making it a moving target,” says Dr. Galsky. “Fortunately, the government has mandated registration of clinical trials on ClinicalTrials.gov. Therefore, we have a comprehensive registry of trials from which to analyze the clinical trial enterprise at large.”
Examining Drive Time
According to the results, about half of patients with metastatic breast, prostate, and colorectal cancer would need to drive more than 1 hour in one direction in order to access a clinical trial site in the U.S. For metastatic non–small cell lung cancer, the rate was slightly lower at about 38% (Table). Several regions were generally associated with the longest travel times, including:
- Mountain regions.
- West North Central regions.
- West South Central regions.
“Our findings support the notion that geographic barriers do exist when it comes to clinical trial participation among patients with cancer,” Dr. Galsky says.
In 2010, the Institute of Medicine released a report noting that clinical trial sites are often selected based on the geographic location of where investigators conducting the study are located. Dr. Galsky says clinical trial access for patients with advanced cancer can improve if it was extended to regions based on where patients live. “The further patients must travel, the more difficulties it creates in recruiting patients to participate,” he says. “Efforts are needed to ensure better access to trials based on geographic proximity.”
Dr. Galsky says that one approach to improve geographic access to clinical trials for patients with advanced cancer is telemedicine. “Research suggests that telemedicine can enhance outcomes among various groups of patients, such as those who present for care at ICUs that have limited capabilities,” he says. “It may be possible to apply this same model to clinical trials for cancer and other diseases.” Dr. Galsky and his team are currently conducting a pilot clinical trial replacing the vast majority of ‘in person’ study visits with telemedicine study visits to ease the burden of participation.
In future analyses, the study recommends that research be conducted to assess the minimum travel time that affects decisions made by patients with cancer regarding their medical care. It is possible that patients living in metropolitan areas have different values of traveling time than those who reside in rural areas. In addition, examining trial accessibility among patients with rarer forms of cancer may also be of benefit.
Galsky MD, Stensland KD, McBride RB, et al. Geographic accessibility to clinical trials for advanced cancer in the United States. JAMA Intern Med. 2015;175:293-295. Available at: http://archinte.jamanetwork.com/article.aspx?articleid=1936578.
Meropol NJ, Buzaglo JS, Millard J, et al. Barriers to clinical trial participation as perceived by oncologists and patients. J Natl Compr Canc Netw. 2007;5:655-664.
Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 2004;291:2720–2726.
Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database: update and key issues. N Engl J Med. 2011;364:852-860.