Increasing Diversity in Trials Requires Understanding Special Populations
A new survey on diversity in clinical trials found that older people are more likely to be asked by their doctors to participate in a clinical trial than their younger counterparts. More than half of older patients were asked by their doctor to participate in a clinical trial compared to 30 percent of patients 34 years or younger.
There is also a correlation between age and interest in clinical trial participation, with 72 percent of people over the age of 65 wanting to be aware of clinical trials compared to 57 percent of those under the age of 34, according to the Center for Information and Study on Clinical Research Participation’s (CISCRP) September survey of 3,600 trial participants.
Sponsors should communicate with healthcare providers about the kinds of trials available and the populations they are looking for so doctors can match patients with trials. This is particularly important to older people, according to Jasmine Benger, CISCRP senior project manager for research, because “they value the relationships with their own doctors more.”
However, doctors are often leery of having their patients be involved in clinical trials because of their concerns about the safety of investigational drugs, says Annemarie Forrest, director of projects for the Clinical Trial Transformation Initiative. Benger and Forrest spoke last week at an Outsourcing Pharma webinar on the survey.
But there is a gap between the elderly and younger people on understanding what clinical research is about. Younger individuals scored lower than their older counterparts in their level of understanding of clinical trials. “Their lack of understanding can impact their willingness to take part in research,” said Benger. “This illustrates the need for more education for participants in clinical research.”
Younger people are more concerned about whether they will be compensated outside of work for their time, according to the survey. And younger people wanted to hear more about where the study would be published and any scientific findings that resulted.
“We want trial participants to make our trials represent real world populations,” said Forrest.
Men and women approach participation in clinical trials differently. Women were less trusting than men of regulatory authorities and sites, Benger said. Women were also less confident in their own ability to find a trial right for them. When it came to understanding informed consent, arguably the most important document in a clinical trial, women, especially younger ones, on average were better able to read and digest informed consent forms than men.
“It is important to note that willingness to participate does not always translate into participation,” said Benger. “It’s really important to focus on subgroups, these individuals need extra support and other areas to focus on as opposed to other populations.”
Increasing participation in clinical trials is also about making things easier for the special populations that you are seeking to include. Women are often the primary caretakers of a family and could be unable to make multiple site visits, so sites should make things easier for them by providing early morning hours and opening doors on weekends.
“Women felt that they were the primary caregivers at home and could not return for follow-up assessments,” said Christina Brennan, Northwell Health vice president of clinical research. “Little things like that kept them from participating.”
Sponsors can also do a better job of removing the need to go to the site by including aspects of hybrid decentralized trial models that mix in telehealth visits, nurse visits or at-home monitoring through bio-wearables.
“What the data really show is that people truly need options, because everyone’s circumstances are a little different,” said Benger.
Something that might sway participants who are on the fence as to whether to participate in a trial might be as simple as making sure participants get the results of the clinical trials.
“We know it is important to engage with patients after the trial ends,” said Benger. “People are left with limited information at the end of a trial.”
Older people, however, preferred to know the benefit-risk balance, to receive a printed summary of the results, whether they had received a placebo, and if there were any other studies that they were eligible for.
Women specifically wanted to know if they were given a placebo and whether the drug was eventually approved.
Read the survey here: https://bit.ly/2LL8Qk6.