Reporter’s Notebook: Speakers Stress 'Patient-Centricity' During SCOPE 2020

Editors’ Note: Companies made several announcements on findings and partnerships during SCOPE. These announcements are reflected in the “News From The Summit” section of this article.

February 27, 2020Members of the clinical trial and research community recently convened in Orlando, Fla, for the 11th annual Summit for Clinical Ops Executives (SCOPE). For four days, pharmaceutical companies, trial sponsors, healthcare organizations, and patient advocacy groups discussed the latest advances and innovative solutions in all aspects of clinical trial planning, management, and operation. Here are some of the bits and pieces we collected during the summit. —The Editors 

Multiple educational sessions highlighted efforts of companies to improve the lives of patients and reduce the burden of clinical trial participation and use of unnecessary medical jargon. The stories shared were largely personal. In her keynote on the importance of health literacy for all, Merck’s Global Health Literacy Director Laurie Myers pointed to her son’s confusion over instructions on his “One-A-Day” vitamin bottle to chew two of the gummies daily. Myers’ own life was literally on the line when she cut a pill in half, mistakenly giving herself a bolus dose of medicine for shoulder pain. 

The career path of keynote Jessica Scott, head of R&D patient engagement at Takeda, was paved by the poor patient experience of her older sister who died at age 19 from osteosarcoma. Scott was drawn to family medicine because of its bio-psychosocial model of care, later went to law school to help fix the broken system it had become, and is now championing a two-way dialogue with patients during the drug development process to “discover what’s below the surface.” 

A small group of clinical trial veterans could be found on stage, and roaming the halls, sharing their first-hand study experiences—good and bad—to the nods of attentive conference-goers. They were eager to share, grateful for the trial opportunities despite the hardships and had concrete suggestions (more to come on this) for improving the situation. 

Such clinical trial participants included those who worked in the trial industry itself, allowing them a unique insight in how to improve the participant experience. Alicia Staley, Senior Director of Patient Engagement at Medidata and cancer survivor, described the stress her parents experienced while going through the consent process when she was diagnosed with cancer at 19. “[The night I was diagnosed], my journey as an advocate began,” Staley said. “I watched my parents—who are both dual-masters from a highly educated, upper middle-class family—struggle for hours trying to go through the binder of consent paperwork. I looked at my mom with tears in her eyes and saw the frustration in my dad’s face, and realized if my parents, with their background and education, can’t make their way through this information to make a decision on whether or not to enroll their child in a clinical trial, then there are a lot of people that are hurting out there.” 

Industry representatives talked a great deal about patients as the rightful owners of their data and the need to develop best practices around sharing results once a study has concluded. Patient-centricity has clearly become a focal point at every level of the clinical trial enterprise; it was notably the buzzword of the summit. 

Staley, in a session tackling patient-centricity by design, said the term is used too broadly to make any meaningful sense. “We have to go back to what the definition of ‘patient-centricity’ is, agree on it, and then figure out how we’re going to measure it.” Rather than seeing patient-centricity as putting patients at the “center” of research, Staley said the industry ought to put patients first

The value of recognizing and celebrating the altruism of trial participants was another significant theme. As reported in a breakfast presentation by Signant Health CEO Mike Nolte, the “backwards” perception in the U.S. is that organ, blood and financial donations all greatly outrank study volunteerism in terms of their contribution to human health. 

There’s often a disconnect between the industry and participants about the purpose of clinical research. Antidote recently surveyed 4,000 patients, asking them why they wouldn’t join trials. The simple answer, Antidote’s CEO Laurent Schockmel reported, is that patients don’t feel they are seen as true collaborators in the research process. “[As an industry,] we’ve operated under the assumption that ‘If we build it, they will come,’” Schockmel said. “But that’s not the case.” People want to participate, he said, so long as their motivators are addressed, which can vary by demographic. For more educated populations, the more information the better; this includes the risks and benefits of the particular trial, as well as what their participation means in the long run. For lower-income populations, transportation or even childcare may be crucial factors that determine whether someone participates in a clinical trial. 

Industry representatives have also made concerted efforts to mend relationships with communities, particularly minorities. 

Representatives from Janssen echoed similar sentiments when discussing ways to include diverse populations in clinical research. Pointing to recent guidance from the U.S. Food and Drug Administration (FDA) as a “game changer”, Janssen’s Associate Director of Diversity and Inclusion in Clinical Trials Lead, Cassandra Smith said broadening the criteria for enrollment to include patients with more diverse backgrounds is necessary both from an ethical and a scientific perspective. Developing strategies to ensure participant diversity from the outset of a trial goes a long way, she said. “If you’re thinking about diversity halfway through a trial, you’re too late.” 

Data is also key to achieving patient-centricity, several presenters argued, not just when discussing what kind of data we collect or from whom, but how and where data are collected is a key determiner in a trial’s success as well. 

Oftentimes resources given to potential participants can be a traffic jam of information, Mike Wenger, Vice President of Patient Engagement at TrialScope said. Patients match to too many trials, murky language in eligibility criteria posted on recruitment databases, and incorrect contact information leads to trial sites becoming overwhelmed with unqualified leads, sponsors potentially delaying trials, and patients never hearing back from sites. Wenger says the right data can remove these barriers for the sponsors, sites, and the patients.

News From The Summit

Several companies and organizations also took the opportunity to make announcements during the summit.

Greenphire teamed up with Roche to address the top hurdles patients face when participating in clinical trials. The companies co-presented findings from a recent global trial survey on patient convenience, highlighting the need to alleviate financial and logistical burdens from participants in order to maximize retention and engagement.

Greenphire and Roche’s collaborative research, which includes responses from 140 sponsors, CROs and sites worldwide, found that the top reasons why patients fail to enroll in studies or drop out prematurely are: time, transportation, visit complexity and expenses.

During a joint session, the companies highlighted findings from the study and explore how to eliminate trial-related expenses for patients, such as transportation, lodging, medications, lost wages, childcare, and more. Attendees learned about the tools available to modernize and streamline the payment process as well as simplify travel for patients, helping sites to better recruit and retain diverse populations around the globe.

Clinical Ink announced the addition of a new component to their Lumenis eSource Ecosystem. With the addition of eConsent, Clinical Ink’s Lumenis platform expands further, providing purpose-built solutions for your protocol and anytime, anywhere access to study data. 

eConsent will join existing clinical modules including direct data capture (DDC), electronic clinical outcome assessment (eCOA), and electronic patient-reported outcome (ePRO) to offer a single, unified data capture system that provides a clearer view of patient data in real time. Newly branded as Lumenis, the eSource Ecosystem captures data right at the point of inception—researchers are able to remotely monitor data and documents immediately, rather than waiting weeks for an on-site monitoring visit. Clinical Ink has integrated third-party eConsent tools for several years; the addition of this additional core capability allows the consent process to work seamlessly with the data capture solution.

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