NCBIO forum explores ways to improve recruitment and experience for patients in clinical trials
Patients and research organizations came together at the NCBIO Clinical Trials Forum to talk about ways to make recruiting and retaining patients easier for clinical trials. The forum was held Wednesday, Dec. 8 at the NC Biotechnology Center.
Matthew Roberts, practice group leader, health care and public policy practice groups, Nexsen Pruet served as moderator for a panel comprising
- Heather-Elizabeth Brown, a “long-haul" COVID-19 patient;
- LaQuinta Jernigan, executive vice president, North America for mdgroup;
- Renée Leverty, program lead, stakeholder engagement, Research Together, Duke Clinical Research Institute;
- Katie Shaw, senior director, global patient and site solutions, IQVIA; and
- Eric South, founder of the Gladiator Project and a glioblastoma multiforme patient.
Finding a trial when you’re sick
Roberts started by asking the patient representatives how they found their way to clinical trials and how their health conditions affect their ability to participate.
Heather-Elizabeth Brown is a COVID-19 survivor, a COVID long-hauler and a patient advocate. After being diagnosed with COVID in April, she came down with pneumonia and was placed on a ventilator for 31 days. She had a stroke while she was in her medical coma and has gone through extensive rehabilitation to recover, including learning to walk again.
Brown said she is involved in several trials, and she found out about all of them through the COVID long-hauler advocacy groups to which she belongs.
“Initially it was very challenging to deal with my health issues and concerns while at the same time navigate not only finding the opportunities for clinical trials but also evaluating their merit, understanding the details and intricate parts of the trial and understanding what my experience would be and what the benefit to me would be,” Brown said.
Eric South was diagnosed with stage four brain cancer in February and had a craniotomy to remove his glioblastoma multiforme tumor. He is a participant in a clinical trial with MD Anderson Cancer Center in Houston and founder of a nonprofit designed to support patients with glioblastoma and help find a cure.
“We had five to six weeks post surgery to make a decision on my treatment,” South said. “The success of the standard of care for GBM is not great. There is no cure.”
“We took a very proactive approach and interviewed neuro-oncologists at MD Anderson, Vanderbilt, St. Thomas and Sloane-Kettering to figure out who was the best option for us to work with.”
South said he had to rely on his wife and his network of family, friends and colleagues to navigate the process of finding a clinical trial that could accept him. “It was not easy. It took a lot of work,” South said.
Patients find trial documentation a challenge
It can be difficult to understand what kinds of patients a study is looking for, Brown said.
“Actually understanding the intricate details of the study was something that was challenging for me,” she said. “I’m educated, I have a master’s degree, but a lot of the terminology that was used was way over my head. I had to call friends who are physicians to ask them to explain it to me.”
She said that the jargon used to describe the kinds of patients the trials are seeking creates a barrier because a lay person has a hard time understanding what patients the clinicians are looking for.
South agreed and said, “My wife is an attorney. My cousin is a pediatric oncologist. And I still had no clue about half of the things we were reading.”
That’s why he and his wife focused on interviewing practitioners at different sites and trials, he said. There was no way that he could comprehend all the documentation he was given in the short timeframe he had, so his ability to trust the people who would be caring for him became central to his decision.
“Ultimately, I decided to trust the organization that I went with for my care,” South said.
The panelists representing the research organizations agreed that high quality informational materials were a priority for their organizations.
“A lot of dollars are spent on patient recruitment, a lot,” said LaQuinta Jernigan of mdgroup. “And yet we hear from patients who are desperate to find a clinical trial, and they had to make it a full-time job to find one.”
It’s incredibly important to have materials that reflect multiple cultures, education levels and socio-economic statuses, she said.
“If you don’t understand what you’re reading, any trust issues you have just become more prevalent,” Jernigan said.
The importance of diversity in clinical trials
Roberts asked panelist to talk about the importance of diversity in clinical trials and why it is important.
Renée Leverty from Duke said that historically clinical trials have enrolled people who were able to learn about the trials, who were available at the convenience of the trial and who were likely to trust the trial organization and process.
“We have to work deliberately to shift our outreach and build trust with the patients and communities we want to reach,” she said.
Katie Shaw of IQVIA agreed, saying, “At the end of the day, these treatment options will be available to all, and we want to make sure that the data we’re collecting is representative of the population that will receive the treatment.”
Jernigan shared her personal experience of having eczema but having never seen what the condition looks like in a person of color.
“Johnson & Johnson just release this ad, and I thought it was quite remarkable,” she said. “It said, ‘This is what eczema looks like on people of color.’ If you were trying to figure out if this is eczema and you googled and looked at images, as a black woman nothing looks like what I have. That’s a huge problem, and it can’t be fixed if we don’t diversify our clinical trials. People need to know that therapies work for them.”
We can thank COVID for bringing the issue of diversity in trials to the forefront, Jernigan said, adding that it remains to be seen whether we can maintain that momentum.
The role of the patient adviser
Leverty talked about how important it is for trial patients to have the assistance of someone with shared experience. Patient advisers may be in the clinical trial or they may have the lived experience that can help inform the study.
“I think it’s critical … to have patient and community advisers help us understand what it’s like for them and how we can best offer support, information and whatever types of incentives … to create ease so that they can participate,” she said.
Jernigan pointed out that a patient adviser has insight into the whole world of the patient who is navigating issues such as travel, lodging, time off from work and childcare that come with participating in a trial.
“Those are the types of insights [advisers] can bring to the table to help us consider every aspect of the clinical trial, not just what we’re reading in the protocol,” she said.
Brown is a patient adviser for two clinical trials. Brown said she received more information and a deeper explanation of the trial as an adviser than she did as a patient.
“As an adviser I feel like a have a more detailed and intimate understanding of the study,” she said. “I feel like a have a more personal relationship with the people who are putting the study together.
“Patients want to feel heard. We make sure that the people who are studying us understand that our experiences are valid.”
The importance of support groups
Support groups provide so much insight into the patient community and what their needs are and allow trial designers to tailor their program to the needs of the patients, Jernigan said.
“When designing a clinical trial, the most important question to ask is ‘Who are these patients?’” she said. “If you don’t have the same shared experiences, then it’s really hard to figure that out. That’s where the patient support organizations come in.”
Shaw said that working with support groups is very helpful when developing materials that share the message and purpose of the trial.
“Going to where patients are getting their information is finding the pathway that they’re walking so you can present the trial opportunity at the right time,” she said.
Brown raised the issue of trust, saying that trust is what determines where patients are most likely to go for information and from whom they will accept it. She said that patients are much more accepting of a recommendation that comes from members of their support group.
“It’s the people who are dealing with the lived experience just like you are,” she said. “It’s the people in the trenches with you who can speak to the validity of this trial or this group that is trying to recruit you.”
Managing distrust of clinical trials
Jernigan said that we have to invite practitioners from rural and inner-city communities who aren’t knowledgeable about clinical trials to participate in clinical research. Trial organizers also need to start involving community and faith-based leaders because they are people that others trust, she said.
“We have not been great at that,” Jernigan said. “People trust the people they know. People trust people who are like them. If we don’t invite those doctors who are often not included to participate, we’re not going to overcome that trust barrier.”
Trials should also provide a lot of information up front so that patients can get answers to their questions, she said.
“Having a clear patient-centric program developed before you start the recruitment initiative will help because patients can see that this is what’s expected of me but this is the support I’m going to have, and that can make a huge difference in their decision,” Jernigan said.
Shaw said she fights misinformation with correct information and materials that explain what clinical trials are and how they differ from standard care that patients are used to. She agreed with Jernigan the trial organizers need to do a better job of reaching out to and involving diverse practitioners and communities.
Leverty pointed participants to A Community Toolkit Addressing Health Misinformation produced by the Office of the Surgeon General.
South said, “You have to trust your doctors, and sometimes doctors are not the best communicators. It’s very important for organizations who are running these trials and having these difficult conversations with patients to make sure the person who is delivering the message is the person who should be delivering that message.”
He said that he decided not to participate in a certain trial because of how uncomfortable he was with the person who was recruiting him.
Brown said, “We want to be humanized and not ‘othered.’ I don’t want to feel like an animal in a zoo. There needs to be a level of compassion and empathy in these trials that goes a long way to establishing trust.”
How the COVID-19 pandemic affected trials
Jernigan said that before the pandemic decentralized trials were only be tried in a few places. Then, suddenly, everyone had to figure out how to implement decentralized trials.
“I think it opened the door to increased accessibility because it’s become the norm to have some of your visits happen in your home,” she said.
She also said she thought that COVID-19 showed us that people do not understand clinical trials and clinical research and that we need to do a better job at the policy level of educating the public.
“We need to get to a point where we are educating children in school about the benefits of clinical research. Start a slogan,” Jernigan said, pointing to the Stop Drop and Roll fire safety campaign.
Shaw said that she believed the pandemic has changed consumer expectations.
“COVID made it easy to order just about anything from your couch, and you drive and someone puts it in your trunk,” she said. “We have to really think about the consumer experience if we want to make that leap into clinical research as care.”
South pointed out that all the emergency waivers in place for the pandemic that allowed trials to see patients remotely were expiring, which reinstated the previous burdens of time and travel on patients. He lives in Nashville, Tenn.
“Now I have to fly to Houston every month just to see my doctor even if there is no major issue,” he said. “I can get blood drawn here. Now I have to go to Houston for that? It’s a major issue, and it’s going to hold us back.”