Two of the pharmaceutical industry’s most important priorities are improving patient access to clinical trials and improving the diversity of patients who participate in trials. To make progress on these priorities, trial sponsors have attempted different patient recruitment and retention strategies with varying degrees of success.

Making better use of community-based clinical research sites can help pharma companies achieve both goals while also shortening trial timelines, reducing costs, and ensuring regulatory compliance—which is an optimal scenario for all stakeholders involved.

The panelists discussed how tapping into community-based research approaches can improve enrollment of the right patient populations, enhance dataset quality, strengthen study relevance, support patient engagement, reduce costs, and incorporate regulatory compliance from the onset.

The panelists included:

  • Jeff Huntsman, Chief Commercial Officer, EmVenio Clinical Research
  • Zhanna Jumadilova, Clinical Lead, Pragmatic Clinical Trials, Pfizer
  • Matthew Kratz, Principal Lead, Patient Strategy and Insights, Parexel
  • Melissa Penn, Director of Patient Engagement R&D, Bayer Pharmaceuticals
  • Meenakshi Valadi, Director of Engagement, Clinical Research Justice League
  • Thad Wolfram, Chief Strategy Officer, EmVenio Clinical Research

Ensuring trial diversity starts with going where diverse patient populations are, in the communities

Clinical research models are evolving from the traditional approach, where a handful of trial sites—often situated in large academic medical centers—would serve as sponsors’ go-to patient recruitment locations, regardless of the target patient profiles or socioeconomic backgrounds of potential trial participants.

In the quest to enroll diverse patient populations into clinical trials, pharma companies are increasingly complementing the traditional approach with community-based models. The reason: the traditional, limited enrollment approach was not as efficient or effective as pharma companies once thought.

“To allow broader patient access to trials, you have to go where the patients are—and patients are in the community setting because that’s where they get care delivered. So it makes sense, from both business and medical perspectives, to reach patients where they are,” explained Zhanna Jumadilova, Clinical Lead, Pragmatic Clinical Trials, Pfizer.

But with sponsors broadening their horizons in terms of where to look for more diverse and targeted patient populations, they need to update their recruitment and retention methodology.

“Traditional sites have been engaging the same patient population in the same way for decades,” pointed out Thad Wolfram, Chief Strategy Officer, EmVenio Clinical Research. “In going out into the community, you have to completely rethink how you’re going to engage, recruit, and retain this broader patient population, which is both the biggest challenge and the biggest opportunity.”

For example, in community settings, improving retention is mainly a result of earning trial participants’ trust. In traditional research settings, on the other hand, high retention rates may be more a function of trial protocol or optimizing logistics.

Meenakshi Valadi, Director of Engagement, Clinical Research Justice League, stated: “At Clinical Research Justice League, we believe that improving patient access [through retention] follows trust. We are focused on earning community trust through engagement, education, and collaboration with sites, sponsors, and CROs.”

To build this trust, pharma companies would benefit by considering ways to become more involved in communities beyond just conducting trials; for example, by hiring locally or giving back to the community in various ways.

Valadi added: “Sponsors should be able to do something for building the communities rather than just extracting data from sites. It’s about being present, staying present, and building true, ongoing partnerships with communities.”

“You have to be a part of the community first before you start talking to people about clinical trials,” said Wolfram. “Adding value to a community that doesn’t have anything to do with clinical trials is a really good way to help earn trust.”

“We need to make medicines with the community, not for the community,” stated Melissa Penn, Director of Patient Engagement R&D, Bayer Pharmaceuticals.

In addition, improving trust in communities in order to recruit new patients into clinical trials requires new forms of outreach. Patients don’t just need more information about a trial or their condition—they need guidance conveyed in plain language.

“We have the internet, and we have information, but we don’t have guidance. We don’t have, ‘What’s best for me? What’s focused on me?’ [Patients] can google their condition and get a million hits, but that doesn’t really help them. They need information that’s actionable, that takes them to a site, and that [connects them with] a community group with fellow patients who are dealing with the same issue and are knowledgeable,” said Matthew Kratz, Principal Lead, Patient Strategy and Insights, Parexel.

Once participants are recruited into a trial, improving retention also depends on How supported they feel throughout the trial, Meenakshi Valadi added. “If patients don’t feel supported or if they are not given the right kind of attention when they participate in trials, there will be a lot of dropouts, and retention will become a real challenge. Inclusive research equals higher retention, better data, and global relevance,” Valadi said.

Practical strategies for community-based research must meet the needs of both site staff and patients

To incorporate community-based research into clinical operations, sponsors must consider the unique training needs of community sites, which often lack the expansive resources, capabilities, and knowhow of larger academic medical centers with extensive research experience.

“It’s about listening to what the needs of principal investigators and research staff are and giving them support, not just telling them what to do, so they can go within their communities and broaden the reach of the trials. That requires a long-term investment,” said Kratz.

To bring community-based investigators into its clinical research network, who in turn can bring new patient populations into trials, Parexel has a site scholarship program and an emerging site network. “Building these networks, training them up, and giving them the support that they need is a long-term investment,” Kratz said.

Another practical strategy for facilitating community-based research is simplifying trial protocols so that participating in trials does not place excessive burden on patients’ time and effort. To achieve this, it is critical that sponsors seek patient input into protocol design early on to ensure that trial requirements are reasonable and that trial endpoints align with patients’ functional health objectives.

Equally important as making sure trial protocols are simplified and aligned with patients’ needs is ensuring that they also work for sites. “The protocols that we build have to be fit for purpose and manageable by sites in community settings,” Jumadilova said.

“In academic centers, many of our protocols’ schedule of activities and eligibility criteria go up to 50 bullet points,” explained Jumadilova. “There are blood draws after blood draws every two weeks… so it’s hard not only for research staff to administer that protocol, but also for patients to be part of the trial long term.”

Bayer’s Melissa Penn emphasized the criticality of co-creating trial protocols and outcome measures with patients—an approach she summed up as “nothing about us without us.” That approach improves the chances of patients enrolling and staying in a trial.

To bring further flexibility to sometimes burdensome trial protocols, pharma companies should also consider whether trial visits can be timed and aligned with patients’ normal clinical visits. “It’s not applicable in every situation, but in situations where it is, we need to try to do that,” Jumadilova said. “It’s a cultural shift for pharma companies because we are built to do science, so with every opportunity, we’re trying to get more data through every protocol. But we have to be able to sit back and think, ‘For this particular research product, do I need patients to come to the site every two weeks?’”

Not approaching community-based research from the perspective of making it easy for patients to participate in trials would inevitably clash with reality. “In the communities, it’s a whole different ball game because [people are dealing with] transportation challenges, food challenges, whether or not they have childcare,” Jeff Huntsman, chief commercial officer at EmVenio Clinical Research, said.

“The industry is very good at using big buzzwords such as ‘patient centricity’ without really saying, ‘What does that actually mean?’ As the industry evolves, we have to [start asking the question of] how do we make it easy for people to participate in trials and what’s the benefit for them,” he added.

In a similar vein, Thad Wolfram highlighted another contradiction in the pharma industry when it comes to partnering with community-based sites. “You hear so much about, ‘We want [to work with] new PIs, we want new sites. But when a study comes up, it’s, ‘I want a PI with lots of experience.’ So immediately these sites get filtered out very quickly.”

Engaging patients in community research improves the quality and relevance of trial data

The key data advantage of conducting community-based research is that as the swath of trial participants broadens, sponsors obtain more representative data of the target patient population that will eventually use the drug.

For sponsors to benefit from this data advantage, though, they have to believe that trial data captured in community settings is of equal quality to data captured in large academic medical centers. This is an assumption the industry often still refuses to fully accept.

“We have research units that look like mobile homes, whose advantage is that you can embed them next to a YMCA or in a Home Depot parking lot because that is the central point in a community. It’s a clinical research site, but because it’s not in a hospital setting, you have to spend all this time justifying that you run clinical research the exact same way that is done in a brick-and-mortar site,” explained Huntsman.

In fact, there is a view by some in the industry that research data captured in community settings can be of even higher quality than data obtained in the tightly controlled environments of academically supervised research. This is because community-captured data is real-world data whose importance is continuously being highlighted by regulators, industry, and patient advocacy groups.

“When you’re able to be more flexible with where data is being captured, that’s more real-world capture of data than when somebody has to go into an academic medical center. So data quality can be better in that [community] scenario,” added Huntsman.

“Not every situation will allow for that,” noted Jumadilova, “but there are many instances where the use of real-world data to generate real-world evidence should be enhanced and driven by sponsors.”

One aspect that should alleviate concerns about the quality of community-based data collection is that much of the relevant real-world data for researchers is already being captured in community clinics’ electronic health record (EHR) systems. Thus, the main issue is not one of data availability or data capture, but of the technology necessary to transfer that data from the EHR to research databases.

“There is EHR-to-ADC technology that exists to do that, but it’s not utilized enough, and there’s technical complexity to it. So the technology still needs to be worked out, but I think that’s the future,” Jumadilova said, referring to automatic data capture (ADC) technology.

Measuring ROI for adopting community research requires starting with the end goal in mind

To measure return on investment (ROI) in community-based research, sponsors need to compare it to the ROI from conducting studies in traditional research sites, such as academic medical centers. Companies also need to employ different financial models to accurately capture the ROI on localized research. Under conventional financial modeling, operators assess ROI through the prism of cost per line item as the study progresses rather than by looking backward from the desired outcome and assessing whether that outcome has been achieved and at what cost.

“There has to be this desire to start looking backward from the endpoint back to the study design,” Huntsman said. In traditional modeling, he noted, “Nobody worries about a 18% dropout rate” due to suboptimal study design, yet such high levels of patient loss can significantly delay trials or even lead to trial cancellation—a negative ROI.

“The real return on investment is, Was that asset able to move faster?” noted Huntsman. “Was the trial able to get more patients enrolled sooner or more patients retained? And were we able to do a health authority submission sooner?”

Valadi added: “Return on investment… we believe in return on community trust, rather than looking at something in the form of dollars. We track that through community referrals across studies, repeat participation, and retention-based strategies that are not relevant to just one protocol, but across studies.”

Conclusion

The benefits of community-based research for patients, trial sponsors, and healthcare at large are undeniable. However, to make such research a standard part of pharma companies’ trial design strategies—in essence, a must-have and not just a nice-to-have component—sponsors need to have a long-term commitment to community-based research and must make long-term investments.

Kratz stated: “You have to build trust and engagement in the community and that takes time. It takes multiple studies, not just, ‘We’re going to use you for this one study and then we’re going to forget about you tomorrow.’ It has to be ingrained in
what you do and how you approach every study.”

“Once we have a more general understanding that the greatest value is right in front of us—in the community and with the community—the business value [of long-term commitment and investment] will become foundational,” added Jumadilova.

“Partnering with communities to reduce the burdens and raise awareness of clinical study participation is fundamental to building trust, achieving representation, facilitating comprehensive recruitment, and ultimately ensuring that scientific advancements are accessible and impactful in real-world settings,” concluded Penn.

This roundtable was hosted by Citeline in partnership with EmVenio Clinical Research and moderated by Derrick Gingery, Executive Editor at Pink Sheet.