(Reuters Health) - Patients, their families and friends may see clinical trial research as important, yet they don’t know much about the research process and see trial participation as burdensome, a new study suggests.
About 85 percent of respondents in the new study said clinical research is important to developing new drugs, and 90 percent thought participating in a trial is generally safe. But only 18 percent had actually done so, researchers report in JAMA Network Open.
“Patient enrollment is one of the biggest causes of drug development delays, and one way to address that is by raising awareness among patients and educating them about research,” said study leader Annick Anderson, director of research services at the Center for Information and Study on Clinical Research Participation in Boston, Massachusetts.
“The end goal is to accelerate the drug development process and bring new treatments to patients faster,” she told Reuters Health by phone.
Anderson’s team surveyed more than 12,000 people, including about 2,200 who had participated in clinical research studies before, about their perceptions of clinical research, how they had received information about research studies and what barriers to joining a clinical trial they had experienced.
Although most participants saw clinical research as important to the discovery and development of new medicines, more than half were unable to name a place where studies occurred. In addition, 45 percent said these trials are rarely considered or discussed as an option when talking to their doctors.
Overall, the respondents saw clinical trial participation as inconvenient and burdensome. Among those who had participated in a trial, about half said it disrupted their daily routine.
“We want to involve patients and caregivers as we develop trial protocols and take a look at all of the procedures and assessments we require,” Anderson said. “We realize it’s a huge commitment to ask of someone, and we’re taking a second look at reducing that burden of participation.”
Previous studies have focused on researchers’ and clinicians’ perspectives of clinical trial research and barriers, often with little attention to patients’ priorities, said Susan Bartlett of McGill University in Montreal, who wasn’t involved in the study.
Even today, many drug trials include few patient-reported outcomes such as fatigue or gastrointestinal distress, she added.
“Fundamentally, we undertake clinical trials to improve the lives of patients,” she told Reuters Health by email. “Our ability to conduct trials is reliant on the altruism of patients and their trust that the trials we design are safe and essential to advancing scientific knowledge and clinical care.”
Bartlett and colleagues have held focus groups in the U.S., Canada and Australia for patients with inflammatory arthritis. They found that what doctors called “nuisance side effects” such as fatigue, diarrhea and gastrointestinal pain were common, persistent and disabling.
Even if a medication helps arthritis, the tradeoff may not matter if the patient feels tired or can’t think clearly, she said.
“Patient-centered research is still in the earliest stages,” Bartlett added. “Our work suggests that the cumulative effect of medication side effects can have a considerable impact on quality of life and often leads patients to reduce or discontinue medications.”
Federal groups are looking for ways to make drug development more patient-focused, which includes identifying the benefits, risks and day-to-day impact of treatments from the perspective of patients.
“Don’t hesitate to speak up,” Bartlett said. “Tell us what we’re doing well, and where there’s room for improvement from the patient perspective. We’ll all benefit.”
SOURCE: bit.ly/2OVdz5g JAMA Network Open, online October 5, 2018.