KO the KOLs? Involve ALL Stakeholders in the Recruitment Process

Patient recruitment remains a challenge for sponsors of clinical trials. Data suggest as many as 86% of clinical trials do not reach recruitment targets within their specified time frames, and low enrollment rates have potentially doubled study timelines beyond intended enrollment periods.¹

In the recent Citeline/Clinical Leader webinar, “Unlock Clinical Trial Enrollment ROI — Transforming Insights from Patients, Sites, Healthcare Professionals, and Partners into Action,” panelists discussed some challenges of patient recruitment as well as possible steps to overcome them.

Ted Trafford is director of business development, Probity Medical Research, a clinical trial consortium with 65 sites spread across five different countries. He says one key point impacting recruitment is development of study protocol, and that there is significant opportunity to improve it from a site perspective.

“So often sponsors will set up a protocol steering committee or an advisory board made up of key opinion leaders, KOLs, to provide them guidance on their protocol design,” he says. “The problem with this approach is that the KOLs may be disease area experts, but they’re not necessarily experts on the clinical operation of the protocol. They frequently come from low-recruiting sites and may be disconnected from some of the operational challenges that we have in conducting clinical trials and recruiting clinical trials. At the same time, the sponsor believes that they’re engaging sites by using this approach, but in reality they’re getting one small perspective on the clinical trial design.”

Trafford says he sees two problems with this strict KOL approach. “One is it’s a very historical-based type of approach where if you’re looking to see what other sponsors have done in the past or are currently doing with clinical trial design, they may be able to provide lots of really good feedback, but the challenge with that is that our current environment for clinical trials is rapidly changing.”

He says the second challenge with strictly engaging KOLs is they may not uncover potential operational or design issues that affect recruitment. “We all know that the vast majority of the work done in clinical trials is done by study coordinators, and especially the study coordinators at high-performing sites,” he says. “My recommendation would be to engage these key experienced performing coordinators and investigators and engage them at the beginning of a program, so starting before Phase II and then continuing that engagement through the life of Phase II and into Phase III.”

Trafford says in an ideal world, there would be an advisory board prior to Phase III that includes key experienced, high-performing sites as well as patient groups to discuss challenges for recruiting in a particular indication. And those meetings would continue through Phase III, he adds.

Including patient groups early on

Patient advocate Tina Aswani-Omprakash, who is living with Crohn’s disease, is executive director and co-founder of South Asian IBD Alliance (SAIA). SAIA is a patient-physician collaborative organization focused on creating resources and minimizing disparities for IBD patients and healthcare providers of South Asian origin.

Aswani-Omprakash, who also has experience as a research coordinator, says she agrees it is important to establish an advisory board with all stakeholders — including patient groups — earlier in the trial process.

“I often get called in as a patient advocacy group or as a patient advocate on my own pretty late into a trial, I would say when the drug’s getting ready to launch or when in the last year of that Phase III,” she says. “And I’m often alarmed at why I’m being called in at such a late stage. … So, I actually agree [with earlier involvement] having seen both sides of the coin really with regards to coordinators doing a lot of the work on the ground.

“In terms of site-specific needs, I think the KOLs, the patient advocacy groups, patient advocates even on their own, and even some of the executives within patient advocate groups who may not be patients themselves, may need to come in much earlier into the trial and advise on the trial design, whether or not it’s patient-centric, whether or not it’s going to attract patients. Also, there’s of course the piece of diversity, equity, inclusion … is this trial being open to different socioeconomic groups or people of color, the LGBTQ population? What is the language like? Is this being inclusive?”

Aswani-Omprakash also says some of the principal investigators (PIs) of the studies should be given a seat on any advisory panel that’s brought together. “I really think all stakeholders need to be at the table to bring forward real change,” she says. “Sort of siloing us and hearing from us in different capacities is not actually engineering the change that we need.” 

Taking the patient’s community into account

Aswani-Omprakash says one thing she’d like to see is industry approaching patient advocacy groups earlier in the trial process to help create awareness.

“We’ve put out a number of papers about how there is not enough access to trials outside of the United States, outside of Western, even Eastern Europe,” she says. “A whole chunk of the world is being forgotten, whether that’s Asia, which is 60% of the world, Africa, South America, there are massive chunks of the world that are not being included readily in clinical trials.”

Aswani-Omprakash says another mistake she sees made by industry is solely focusing on the physician piece and forgetting about patient and caregiver education.

“Why do I emphasize caregiver education?” she asks. “Because in our Asian communities, even Middle Eastern communities, there is this propensity towards the family making a decision. This is not just a shared decision between a patient and their provider. This is a family making a decision saying, ‘Hey, you know what? We are really concerned about this clinical trial and not knowing much about this medication for my child or for my spouse or for my sister’s disease. Why does this matter?’ And that’s one thing I want to make sure I emphasize is this is not just a one-person disease. This involves the family in some communities of color, and we need to recognize and respect that.”

Krystyna Chmura, clinical trial solutions senior advisor, life sciences data, Evernorth, partners with trial sponsors around their patient recruitment and study design strategies. She started her career working with patients in a one-to-one capacity as a clinical research coordinator at a local CRO in her home state of New Jersey.

When it comes to educating the public around clinical trials, Chmura says, the industry could do a lot better. “Dispelling myths around clinical trials really starts with patient education,” she says. “[There are] common misconceptions … I heard time and time again when I was a clinical research coordinator. And I’ll start with the first one, that trials are only for people with no other options. Another one I commonly heard was that if you enter into a trial, you’re only going to get a sugar pill or a placebo instead of a real drug. And if you enter a trial, you’re just going to be a guinea pig. All those sentiments are simply false.

“What we can do more of is provide appropriately tailored education around the trial to reduce both the real and the perceived burdens around the patient’s participation in a trial. We have to be mindful of a participant’s age, their gender, location, socioeconomic status, their education level, because we really understand now how that impacts the proficiency of health literacy, the trust in the healthcare system, and a patient’s readiness or willingness to make a well-informed decision around their trial participation.”