Applied Clinical Trials
Jill Wechsler discusses the importance of clinical trial participants and the challenges FDA faces in expanding patient engagement.
A main reason for high costs and delays in launching and conducting clinical trials are difficulties in enrolling sufficient numbers of patients in studies. Greater interest in testing new medical products on a broader range of age and ethnic subgroups adds to the challenges in launching and carrying out informative research studies.
Efforts by FDA to expand patient engagement in the many issues related to medical product development and oversight may help address these challenges in biomedical research. A new Patient Engagement Advisory Committee (PEAC) established by FDA’s Center for Devices and Radiological Health (CDRH) plans to examine factors that may deter patient participation in clinical trials as its first order of business. A panel of experienced patient advocates and disease group leaders will discuss patient concerns about clinical trial design and conduct involving medical devices at its inaugural meeting on October 11-12, 2017.
Last March, FDA launched a campaign to educate Hispanics and other minority groups about the importance of biomedical research and need for broad participation in clinical studies. A main aim is to encourage physicians and health centers to steer patients to appropriate trials or resources on clinical research. FDA has solicited formal comments from all stakeholders, including patients, caregivers and advocates, on whether the agency should establish a new Office of Patient Affairs, as part of efforts over the past five years to expand and strengthen patient involvement in FDA oversight of medical product development and review.
Analysts at FDA and health professional societies also are examining the lack of older adults in clinical trials, a serious shortcoming for diseases that heavily affect the elderly, such as cancer. The American Society of Clinical Oncology (ASCO) issued recommendations two years ago calling for more older adults to be included in more cancer studies, but officials at cancer centers find progress slow. Many seniors end up ineligible for clinical trials due to comorbidities and use of multiple medications.
One small positive note is that expanded health care coverage under Obamacare of the routine costs related to clinical trial participation appears to have increased clinical trial participation slightly in recent years. A study published in the journal Clinical Cancer Research July 20, 2017 indicates that the requirement to cover “standard of care” costs related to clinical trial participation, which went into effect in January 2014, speeded up the process for privately insured patients to gain approval for trial participation, and fast decisions are vitally important for patients with advanced disease states.