Q&A with the NCBIO Clinical Research Forum panel explores clinical trial barriers
An expert panel explored the current state of clinical trial participation at the NCBIO Clinical Research Forum held Tuesday, Nov. 29. The panel was moderated by Abby Emanuelson, executive director of Care4Carolina, and comprised
- Rose Blackburne, M.D., vice president, global product development, PPD, part of Thermo Fisher Scientific;
- Erin Finot, vice president, immuno-oncology and cell and gene therapy, IQVIA Biotech; and
- Julie Harrell, director, patient enrollment liaisons, Ultragenyx.
Panelists talked about ways to lower the barriers that stop patients from participating in clinical trials and discussed strategies for achieving diversity. They also explored the role of patient advocates and gave special consideration to efforts focused on rare diseases.
What have been the most significant changes in the way you promote clinical trials to get patients involved?
Blackburn: “I think keeping the patient's point of view in mind across the spectrum of drug development is kind of new but should not be. Making that a focus so that trials are accessible to all patients. Whether we're talking about diversity or rare diseases, making sure that patients understand what clinical trials are about. We saw a lot of confusion and concerns during the vaccine development these past few years with COVID.”
Finot: “Having avenues to capture more patients and increase patient access is something that we very much have to do to deliberately recruit patients, especially patients with rare and ultra-rare diseases.”
IQVIA continues to use traditional channels like radio to reach patients but is now mixing it up it up with social media and other advertising, such as a bus-stop ad campaign in the Washington, D.C. area, she said.
“It's really becoming a multichannel, multitier approach because we know that one size, in fact doesn't fit all patients."
Harrell: “Instead of taking an overall general approach, we're trying to be really specific and really dive in. So for example, looking at one of our trials, we're looking at 20-something-year-olds. They don't use Facebook, they’re on TikTok. They're already discussing what their disease state is. They're bringing in more people around the world. So how can we join in that platform?”
Blackburn: “One of the other strategies that we're using is using epidemiologic data. We can drill down to the zip code to look at disease prevalence and then overlay that with potential investigator sites. So instead of having patients come from afar to go to an academic center like Duke or Carolina, there may be a community physician or a smaller, less experienced site closer to the community where there's high disease prevalence.”
Blackburn said that Thermo-Fisher checks to see if community practitioners are interested in becoming clinical trial investigators. "We have a tool which we call Site Coach where we will train a site, a practice, in GCP and give them all the tools they need to become a high quality, impactful investigator site.”
Finot: “An additional way in which we're kind of revolutionizing the trials space is bringing trials to patients, rather than bringing patients to trials. COVID has been a really great catalyst to truly innovate and transform the clinical trial space. A lot of what we talked about when I got in the industry 20 years ago about being bringing trials to patients is actually true today so that has been great.
What intangible barriers to clinical trial participation are out there?
Blackburne: One of the challenges that we face in clinical research is envisioning what trials are going to look like five years from now 10 years from now, and what technologies we haven't even thought about.”
“We have a lot of tools. we have a site mobile van, but not every community and every patient wants the van to pull up in their neighborhood and they hop on because of privacy, but some patients like that. Everybody does not want a home nurse coming into their home. Some patients love it, but everybody does not like that. We can deploy tablets for telehealth, but we also need to be mindful that every patient doesn't have reliable internet. So as we think about these wonderful tools, we have to really talk to patients to see what works for them what they think, what they want.”
Harrell: “COVID took not just every restaurant worker but every nurse, every study coordinator. I don't know where COVID put these people, but they haven't come back. Imagine your patients out there trying to get in to a clinic period, much less a clinical trial, and they can't get through. Everyone's too busy. And now guess what? We have RSV [respiratory syncytial virus]. So we have clinical trials sites that are in children's hospitals that have just shut down. We can't get our clinical trial patients in.”
How do you work with patient groups to design and conduct clinical trials and research?
Blackburne: “I think it's another example of there's no one size fits all approach because patient advocacy groups are very different. What kind of partnership and value can we bring and what value can their patient groups bring to the protocol or to the development process? I think it has to be, again, iterative but really talking and understanding where we can partner and ally.
Harrell: “Because our disease states are ultra rare, advocacy groups are very important to us. We have some disease states where there's only one advocacy group that has representation in the EU, UK, as well as in the US. So, we work very closely collaborate with them. We get their buy-in on our patient materials.”
Ultragenyx has a team of physical and occupational therapists who work with patients on protocol development for trials
“An example is a standard of movement is a six-minute walk test. It's in every protocol, right? Well, some of our diseases are neurodegenerative, they can't walk six minutes. They can't walk at all. So we have to rethink the standard and how that standard going to be accepted globally.”
Finot: “Those same patient advocacy groups also become advisors to my typical biotech customer. Oftentimes, these groups will provide insights so that the biotech customer makes their protocol a little bit leaner.
“Do we really need six serial biopsies? That's the oncology equivalent of a six-minute walk test. Do we really need 36 hours of PK samples? How can we operationalize this trial allow patients to participate still enrich the science and the information that you're getting as an outcome you the biotech sponsor are getting as an outcome but allow patients to participate?”
“I do see patient advocacy groups having a really strong role in protocol design and also, on occasion, being advisers to my biotech customers to help optimize their own drug development.”