Patient-related challenges are among the top concerns of sponsors and CROs, according to a recent global survey of biopharmaceutical companies, CROs, consultants and others involved in the clinical research process.
Of 427 clinical trial professionals surveyed, 75% said “putting the patient at the heart of the clinical trial” is the top priority for their organization in 2015.
Their greatest challenges to conducting successful clinical trials included speed of enrollment (42%), narrowing patient eligibility criteria (23%) and patient retention (20%).
“Patient centricity is seen as a key factor in improving both the efficiency and the focus of clinical trials, although it also is perceived as being so important to the new pharma operating and commercial model that 21.24% of respondents reported it being a company-wide imperative,” according to eyeforpharma, which conducted the survey focusing on patient centricity, technology and data last fall. “That said, a worrying 16.52% of respondents reported that ‘no one is spearheading the concept.’”
Of those championing the patient-centricity concept, the survey showed nearly 20% are CEOs or other board-level executives and 14.75% are clinical operations, followed by the chief medical officer (7.6%), medical affairs (6.49%) and clinical design or clinical development organizations (5.6%).
“Patient centric means thinking differently about planning and conducting clinical trials,” said Helen Raff, eyeforpharma’s head of clinical, Europe, who commissioned the study, in part, for an upcoming London conference on patient-centric clinical trials. “This is not about a technology change, but rather a gradual process across the entire clinical trial continuum.”
The 10-question survey in part asked participants which tools would become more important for recruiting patients over the next two years. Their responses:
“Web-based portals stand out because that is one of the best forums for engaging patients now, versus the older style of educating patients with flyers and brochures,” said Ulrich Newman, eyeforpharma’s global director, who coordinates its clinical trial efforts. “These portals are perceived as innovative. They’re a channel for patients to engage with their study investigator. At the same time, there are compliance concerns over what pharma companies have to do to meet various regulations.”
Bonnie Brescia, founding principal of BBK Worldwide, who participated in the survey, questioned the use of patient advocacy groups in clinical trial recruitment, citing the more important need for these organizations to help set the research agenda and make sure the voice of the patient with a specific condition is heard.
“Their role in the early planning, design and study is less about recruitment support and more about setting up studies and being more conscious and respectful of patients’ experiences with the disease,” she said.
Brescia also was “pleasantly surprised” that only 17% of respondents said no one was spearheading the patient-centric concept, a rate lower than she expected.
“The question in the coming years is: how do we truly move to patient-centric study designs by setting priorities for research, and work with patients on how they are treated during trials, and how to best measure the speed of enrollment and retention.”
In a 2014 white paper on patient-centered trials, eyeforpharma called patient-centered clinical trials a new paradigm that engages patients and patient partners— including individual patient advocates, patient advocate groups, physicians, family, caregiver and virtual patient communities, starting in the early phase of study development. Patient recruitment involves the clinical trial team, patient advocates and the patient partners, with social media enabling patients and their physicians to learn about available clinical trials and match patients to the right trials.
Once enrollment is complete, the patient partners, site staff and support staff must provide the needed support at pain points thoughout the patient’s participation and be sensitized to look at relevant patient data and reactions early on and throughout the study.
“Patients—the industry’s ultimate customers—potentially are the big winners from the new course that the industry has embarked upon,” the survey concluded, “thanks to their new seat at the healthcare table of influence.”
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