Responses from 30 participants in a recent roundtable as part of the Tufts Center for the Study of Drug Development (CSDD) Executive Forum indicated that 48 percent of their phase II and III trial sites missed enrollment targets in 2015 and 11 percent failed to recruit a single patient. Fewer than half of patients screened for these trials actually completed them, according to the newly released R&D Management Report from the Tufts CSDD.

The findings were all the more compelling considering that input came from a broad cross-section of stakeholders, including big pharma and biotech companies, contract research organizations (CRO), patient recruitment firms, information technology specialists and representatives from academic investigative sites.

R&D executives have awakened to the bruising reality that improving patient recruitment and retention is "mission critical," according to Ken Getz, associate professor and director of sponsored research at Tufts CSDD. The need to improve patient enrollment and retention has become even more urgent with the emergence of precision medicine, which requires investigators to recruit volunteers from more narrowly defined and limited subpopulations.

Challenges in managing the efficiency of drug trials also come amid growing pressure from patients, physicians and politicians to accelerate the pace of drug development and to cut the cost of end products.

Biopharmas are experimenting with a variety of approaches, including the use of big data to identify and understand patient populations and of outreach mechanisms such as social media to interact with and engage patients. But the same old problems persist. How do biopharmas connect with patients on a personal level? How do they develop a relationship of trust? And how do they convey the value of participating in clinical trials?

The answers to those questions start with local physicians, Getz said, noting that drug developers must work harder to form collaborative relationships in the community.

Engaging health care providers "is one of the major new frontiers where research needs to go if it hopes to see major improvements in recruitment and retention effectiveness and in the overall speed and efficiency of drug development innovation," Getz told BioWorld Today. "It's critical that companies and research centers find ways to partner or to engage the broader health care provider community."

'THE CHALLENGE IS HOW TO CUT THROUGH THE NOISE'

The Tufts CSDD data suggest some simple fixes, including better communication and even common courtesy, to improve the dialogue. More than half (53 percent) of doctors who responded to a recent Tufts CSDD survey said they were somewhat or not at all familiar with clinical trials. Of those who were aware of trials, only 7 percent expressed fear of losing patients as a reason for not referring. Most – 54 percent – said they simply lacked access to trial information, and 48 percent were unsure where to refer patients.

In terms of engagement, 29 percent of physicians who had participated in a trial said they never received updates during the trial, and 42 percent said they didn't receive a call from the principal investigator following the trial. In a telling statistic, 82 percent of physicians said they'd be more willing to refer patients if they developed a working relationship with a clinical trial investigator.

Most physicians want their patients to have access to the most effective therapies, and most patients trust the recommendations of their physicians, Getz maintained. But in the context of delivering patient care in the broader health care system, "the challenge is how to cut through the noise and make information accessible at the time that patients and physicians need it," he said.

The typical approach to clinical trial recruitment is to "throw more information at the health care provider," but this tactic "plays into an already stressed and overstimulated community," Getz said. "It hasn't really worked."

The patient-centric movement has the opportunity to be a mobilizing force in trial recruitment, allowing patients "to drive the engagement of their support network," including physicians and payers, he pointed out. When a patient community has a vested interest in the outcome of a clinical trial and sees a genuine opportunity to address an unmet medical need, "that will start to drive some real improvement in this problem," Getz said.

But to improve trial efficiency, drug developers, academic centers and CROs still must work together to put the right pieces in place. According to the Tufts CSDD report, some important components include:

• Site timeline: Everyone on the team must be on the same page about the definition of "site ready," which often is not the case. Achieving site readiness ahead of enrollment increases site months, provides a larger enrollment data set and enables course corrections.

• Investigator meetings: Members of the study team should agree on the importance of patient recruitment and engagement as keys to a study's success. Site adoption rates are 49 percent greater when the recruitment program is introduced prior to the first patient's enrollment, according to Getz.

• Number of patients screened: To ensure that the right patients are available at the right time, trials should monitor last-patient-in projections based on actual screening and consent rates and have vetted and approved contingency plans and budgets in place.

Given the ineffectiveness of traditional recruitment methods, such as advertising, drug developers also have increased their use of social media, which already supports communication within patient communities. More than 70 percent of U.S. adults are on Facebook, for example, raising its potential value as a recruitment tool, according to the CSDD report, which noted that the Discovery Clinical Trials site on Facebook helped to increase awareness of trials among target populations more cost-effectively than ads, posters and broadcast media.

Google Adwords can enable investigators to gain greater access into target populations at the same cost or less than other paid media. And Twitter, while not used directly in patient recruitment, can direct readers to additional information, such as blog posts, that address the needs of specific patient populations and raise awareness of relevant clinical trials.

But social media has a serious downside, Getz said, warning that solutions seeking to offer "broad reach at lower cost" remain less effective than classic relationship-building among the research center staff, the patient community and the referring physician.

"At the end of the day, a patient's willingness to participate in a trial is predicated on the sense that they're being cared for, and that's a very personal experience," Getz said. "I think we're going to see a movement away from the purely high-tech approach toward a blending of technology solutions and personal relationships."