A new study examines why so few people are signing up to participate in medical trials.
Many, if not all, of the features we do on medical research are dependent on clinical trials. Testing the effectiveness of therapies is the way new drugs go to market and how new treatments are approved for patients.
But there are increasing concerns among researchers - and patient advocates - that the number of people enrolling in clinical trials in this country is not as high as it needs to be. The question is why - and it turns out that not a great deal of research has been done into public attitudes towards clinical trials.
Researcher Kathryn Flynn set out to change that by creating a study through the Medical College of Wisconsin's Center for Patient Care & Outcomes Research.
"We're trying to improve the quality and efficiency of trials, we're trying to improve how safety is reported, but what do patients think?" she says. "What do people who actually are going to participate in these trials think?"
Not understanding safeguards
Her study on people's perceptions of clinical trials appears in the latest edition of the journal Clinical Trials. She found that most of the people surveyed, regardless of whether they had participated in clinical research before, had a good understanding of the basis of clinical research.
But she says many of those polled didn't know about the safeguards in place to protect trial participants.
"There are lots of safeguards in place and when those things are followed, which we hope that they are and I think that they typically are, they do protect humans who are participating in research," Flynn says.
Flynn's study took participants through what happens in a typical clinical trial, including the institutional review boards, ethics committees and federal regulations that monitor such activities.
"People were comforted actually, they were glad to know that these things were there and that there were people looking into the conduct of trials and making sure people were protected," she says.
Concerns about regulations
That was especially important for participants worried about "adverse events," a side effect or a medical event that can happen during a trial.
"If you have a headache or you have a heart attack, it's not obvious whether that's because... you're predisposed to have a heart attack, or because it was a side effect of the drug," she says. "So there is a lot of regulation in place for what happens when those things occur."
Flynn says medical research in the United States hasn't always followed such procedures, creating a legacy of suspicion. For example, the infamous Tuskegee experiment left syphilis untreated in a group of African-American men without their consent.
"Often African-Americans will have less trust in the health care system and especially in research, and so we wanted people to feel comfortable in these groups talking about concerns they have," Flynn says.
But she says all four surveyed groups, regardless of race or previous clinical trial participation, expressed concerns over clinical trials' safety.
She says that's where patient advocates come in, helping doctors and researchers better consider the patient's perspective. For example, researchers might interpret vague language on a consent document much differently than a participating patient.
So as clinical trials get more advanced and tread into more ethically muddy waters, Flynn says it's important for researchers to take into account what participants are thinking and what they really understand.
"The way that we communicate with each other and regulate these trials to make sure that people are being treated the same in each of those different sites, it's essential that the entire enterprise moves along with the times," she says.