Summaries of research studies of the clinical trials process. These studies inform the design and development of clinical trials.
On this page:
Trial Development Process
Cost Issues
Barriers to Participation
Trial Development Process
- Mayo Clinic Streamlines Development Process for Cancer Trial Protocols
By streamlining the development process for clinical trial protocols, the Mayo Clinic Cancer Center reduced by approximately 40 percent the time from the initiation of protocol to submission of the document to an institutional review board (IRB) for approval. - A Sense of Urgency: Rethinking the Clinical Trial Development Process
Can lessons in efficiency from private industry reduce delays in opening clinical trials?
Cost Issues
- Cost of Treating Cancer Patients in Clinical Trials Just Slightly Higher
The most comprehensive study yet on the issue confirms that there are only slightly higher patient-care costs associated with treating patients in cancer clinical trials compared to treating similar patients outside of trials, according to the June 11, 2003, issue of the Journal of the American Medical Association. - Clinical Trials Appear Not to Drive Up Cost of Cancer Treatment
Some health insurers, concerned that participation in a clinical trial drives up the cost of cancer care, decline coverage to patients enrolled in cancer trials. However, the results of an April 2001 study by Thomas N. Chirikos, Ph.D. and others at the H. Lee Moffitt Cancer Center in Tampa, Florida, offer no basis for such a policy.
Barriers to Participation
- Study Identifies Cancer Patients' Concerns About Joining a Trial
In one of the only studies to systematically assess cancer patients' feelings about taking part in clinical trials, researchers have identified a number of barriers to enrollment. Two of the main barriers are patients' concern that joining a trial might reduce their quality of life and that they would receive a placebo, according to the February 2006 issue of the Lancet Oncology. - Minorities Just as Willing to Participate in Health Research
Americans from ethnic and racial minority groups are as willing to take part in health research studies, when invited to do so, as other groups of Americans, a new study finds. - Electronic Alert System Increases Patient Referral and Enrollment in a Clinical Trial
Doctors at an academic medical center referred 10 times as many patients to a clinical trial, and enrolled twice as many, when they were alerted by means of a computerized medical record system that their patients might be eligible to take part in the trial. - What Barriers Keep Older Patients Out of Cancer Clinical Trials?
The authors of this report from the May 1, 2005, issue of the Journal of Clinical Oncology systematically review what's known about the barriers preventing older patients from taking part in cancer clinical trials. - Age Alone Should Not Prevent Older Patients from Enrolling in Clinical Trials
Evidence is mounting that persons over the age of 65 who are reasonably fit tolerate the aggressive chemotherapy treatments often given in cancer clinical trials as well as younger persons do. According to these studies, age alone should not be a barrier to participation in clinical trials of new cancer treatments. - Removing Insurance Barriers Not Enough to Improve Clinical Trial Participation
In two studies, researchers from Yale University School of Medicine conclude that the removal of insurance coverage barriers is not enough by itself to improve enrollment in cancer clinical trials. - FDA Study Shows Older People Are Underrepresented in Cancer Clinical Trials
A large study by the U.S. Food and Drug Administration (FDA) reinforces earlier findings that, although most patients diagnosed with cancer are aged 65 or older, relatively few older patients with cancer are enrolled in clinical trials of new cancer treatments in the United States. - Doctors, Patients Face Different Barriers to Clinical Trials
As suggested by two surveys and a series of focus groups, the vast majority of cancer patients are unaware of clinical trials and physicians aren't enrolling patients because they don't have the time, staff, or funding to do so.