With any clinical trial, Jacqueline Corrigan-Curay, director, Office of Medical Policy at the US Food and Drug Administration (FDA), said researchers must carefully assess if the benefits of enrolling a particular participant in a study outweigh the potential risks.
In geriatric trials, however, there may be additional risks due to comorbidities and concomitant medications that tend to increase with age, Corrigan-Curay told us.
“As older participants may also suffer from diseases that limit mobility, the ability to travel to clinical trial sites may also be more challenging,” she explained.
To help reduce the burden of travel, Corrigan-Curay said strategies using innovations such as telehealth approaches may help reduce the number of in-person visits required for a study.
Several contract research organization (CROs) also have established partnerships to provide travel assistance. Earlier this year, the transportation service company Uber launched a new health care offering – Uber Health – to expedite patient transportation.
Such logistical and financial support may be helpful to facilitate participation, Corrigan-Curay said.
As part of this, the FDA recently updated its guidance on payment and reimbursement of research participants to clarify that reimbursement for travel expenses and associated costs, such as airfare, parking, and lodging, are not considered “undue influence” and are “generally acceptable.”
“In addition, engaging caregivers for elderly participants may enhance patient adherence to the clinical trial protocol and provide additional support,” explained Corrigan-Curay.
Guidance
Though enrollment of geriatric populations remains a challenge, the FDA has been leading efforts to include older adults in trials since 1983.
FDA guidelines establish common principles to encourage the inclusion of elderly in clinical trials to support drug development and approval, said Corrigan-Curay. The agency finalized guidance in 1989 on including the elderly patients over the age of 65 in clinical trials. More recently, an amendment to the ICH-E7 guidance encourages the inclusion of patients over 75.
Additionally, the FDA’s internal guidance for its staff who review protocols states that “arbitrary upper age limits for trial entry are almost never justified and should be discouraged,” explained Corrigan-Curay.
“There have been renewed efforts by the FDA and NIH to include older adults in clinical trials,” she added. Specifically, the 21st Century Cures Act requires the National Institutes of Health (NIH) to examine the barriers to including older adults in trials and identify ways to include “a spectrum of ages.”
AS Corrigan-Curay explained, applications to NIH for research must describe plans for including individuals “across the lifespan, with scientific justifications for both the age range specified in the context of the study and any exclusions” beginning in 2019.
Workshops
In June 2017, NIH organized a workshop, which Corrigan-Curay said highlighted “the desire from all stakeholders to avoid unnecessary exclusions of all kinds, including those based on age.”
More recently, and as a part of FDA’s efforts required under Section 610 of the Food and Drug Administration Reauthorization Act (FDARA) of 2017, the Agency held a public meeting to discuss clinical trial eligibility criteria to inform a guidance on the subject.
The workshop – Evaluating Inclusion and Exclusion Criteria in Clinical Trials – emphasized that exclusions should be based “on a careful assessment of the need for such exclusion to avoid arbitrary exclusion of patients from participating in clinical trials.”
“The conclusion from the workshop was that enhancing inclusion and encouraging greater diversity in clinical trial populations is a priority for regulators, sponsors, investigators, and patient advocates,” said Corrigan-Curay. “This workshop represents another important step in ongoing efforts by the FDA to move towards more inclusionary clinical research.”