New Study: Location Limits Cancer Clinical Trial Participation

A new study published in the Journal of American Medical Association (JAMA) suggests that geographic location severely inhibits a cancer patient’s likelihood of participating in a clinical study, Reuters reports.

Andrew Schafer, president of Industry Standard Research, a consulting firm in North Carolina told NewsObserver, that the number one cause of delay in drug development is failure to recruit an adequate number of participants for clinical trials. Eighty percent of clinical trials fail to meet their targets, a growing concern of contract research organizations (CROs).

While phase 1 clinical trials can proceed with only a small number of participants, phase 2 clinical trials require hundreds and phase 3 requires thousands from multiple countries. Those participants must meet a very specific criteria as clinical trials become more complex and specific and FDA regulations become more strict, NewsObserver reports.

Despite this need, authors of the JAMA study note that only 2 to 7 percent of U.S. adult cancer patients participate in clinical trials.

The authors used data from ClinicalTrials.gov to see how many sites were conducting clinical trials for breast, prostate, colorectal, and non-small lung cancer treatments and found over 5,000 locations.

Using data from the CDC, they found which zip codes had the highest mortality rate for those specific cancers and estimated the time needed to drive to one of the clinical trial location sites. Their study found that half of patients suffering from colorectal would have to drive more than an hour to participate in a trial study; the same was found for non-small lung cancers.

The rarer and more specific the cancer, the more difficulty a patient would likely encounter trying to reach a testing facility.

Reuters cites another study from 2007, which indicates already reluctant patients are usually unwilling to make that kind of travel commitment, despite the possible advantages.

Matthew Glasky, lead author of the study from Mount Sinai, told Reuters, “Clinical trials are the basis for the vast majority of advances in cancer care, so, the only way to move the field forward is for patients to participate in clinical trials.”

Glasky goes on to explain several strategies for making clinical trials more feasible for more patients. “Regulatory and financial barriers to opening trials at multiple sites, including multiple community sites, need to be addressed to make this process much less burdensome,” he said.

According to NewsObserver, many CROs are investigating the possibilities of Big Data and clinical trial systems where patients upload their results into a data cloud accessible by multiple research facilities and would make patient location less of a factor in recruitment.

Both NewsObserver and Reuters report these design ideas are still in early development.