FDA Efforts to Increase the Number of Clinical Trial Participants

FDA Efforts to Increase the Number of Clinical Trial Participants


Difficulties with patient recruitment in a timely manner and in sufficient amounts are one of the major reasons which make new drug development costs go high, causing delays and otherwise making new products' launch even more challenging. The conduct of clinical studies is dramatically complicated by the growing demand for the new medications to be tested on a broader range of ethnic subgroups of different ages.

FDA’s ample efforts to expand patient engagement may prove helpful in addressing product development and oversight challenges in biomedical research. One of such efforts is the PEAC (Patient Engagement Advisory Committee) created with the aim to examine factors that are likely to deter patient participation in clinical trials. At the committee’s inaugural meeting planned for October 11–12, 2017, its experienced disease group leaders and patient advocates will discuss patient concerns regarding clinical trial design and conduct involving both medical devices and drugs.

In spring of 2016, a campaign launched by FDA was aimed at educating ethnic minority groups about the importance of biomedical research, emphasizing the importance of broader participation in clinical trials. The objective of the campaign was to encourage health centers and physicians to guide patients to appropriate clinical studies or resources. The Agency solicited comments from patients, advocates, caregivers and all other stakeholders regarding the establishment of a new Office of Patient Affairs. This body is planned as yet another one of FDA’s five-year-long efforts to strengthen and expand patient involvement in its oversight of drug and medical device development and review.

Lack of older adults is another difficulty clinical trials have to deal with. This problem is being analyzed by FDA as well as other health professional societies due to the considerable limitations to clinical trials of such medical products as cancer drugs which are developed for this category of patients. And even despite the two-year-old recommendation issued by ASCO (American Society of Clinical Oncology), calling for older adults to participate in more cancer studies, the progress at cancer centers is still slow. The process is affected further by the fact that many seniors become ineligible for clinical trials because of using multiple medications or due to comorbidities.

However, there is a positive feature, too: a slight growth of clinical trial participation in the past few years. This became possible due to the expanded health care coverage provided by Obamacare for the routine expenses incurred by clinical trial participation.  Gone into effect in January 2014, this coverage speeded up the process of trial participation approval granted to privately insured patients – a crucial thing especially for patients with advanced states of lethal diseases.