Giving Patients Back Their Voice in Clinical Trials

October 28, 2019

When clinical trial participants talk about how they feel entering a study, three words stand out: vulnerable, overwhelmed, disconnected.

If sponsors want to commit fully to engaging patients in their trials, they need to focus on providing an experience that is the opposite of those three words, making patients feel safe, supported and included.

Clinical trial experts and patient advocates discussed ways to achieve that approach to the patient at the 2019 WCG Patient Advocacy Forum in Washington, D.C., last week.

The number one thing sponsors overlook, says trial veteran and author Mary Elizabeth Williams, is that once a patient is diagnosed with a disease, the patient’s whole world changes.

“No matter how much agency you have and confidence, when you become a patient, you instantly become vulnerable,” said Williams, a survivor of metastatic melanoma.

“You sit there in a paper gown with no shoes,” she said, “and the doctor will tell you what to do, and what you can’t and when.” Patients become passive vessels for testing drugs and have no voice: their only role is to take orders.

Patients need to feel they have made an active decision to participate in research, not just that a trial is their last and only chance. “We consent to clinical trials like we do to the updated terms of service” for the latest version of our smartphones, Williams said.

Many trial participants feel like they are not really informed about a clinical trial and what they are consenting to. Being swiftly baptized into a clinical trial can leave the patient with a whirlwind of paperwork and the feeling that they don’t understand the science involved.

Rather than handing a patient a 20-page informed consent document full of long paragraphs and giving them only two minutes to read and sign it, patients should be guided and educated. This is where the concept of a nurse navigator can be helpful.

“Nurse navigators make a difference,” said cancer survivor Amy Joosten-Butler, who has participated in five clinical trials and is about to start her sixth. Joosten-Butler said her nurse navigator walked her through the informed consent document, distilling the information for her page by page.

Not all patients have the benefit of a guide, however. “I had to become a nuclear physicist to become an ambassador” for patients, said Kimberly Richardson, head of patient-centered outcomes in cancer research at the University of Chicago. “What regular person would do that? That’s an inherent barrier right off the bat, ‘Become us to be like us.’ That won’t work in patient advocacy.”

Patient engagement should go beyond the trial, experts and patients agreed. Too few trials share their end results with the participants.

Too often, results are only shared if they are successful,” said Seth Rotberg, Huntington’s Disease advocate and partnerships manager for Inspire. “Share it with the people who took the risk first,” Rotberg urged.

“I was lucky,” Williams said, noting that she lived in Manhattan, had a flexible work schedule and was treated by a Nobel Prize-winning scientist at a great hospital. “I know how to ask questions as a journalist as well. I had all of that and it was the scariest, most nail-biting, traumatic thing in the world.”

By Colin Stoecker