SCOPE award salutes heroic innovation in clinical trial solutions

The finalists have been announced for the sixth annual Participant Engagement Award (PEA), an awards program that honors innovative clinical trial solutions. The judges will crown a winner at the 2022 Summit for Clinical Ops Executives (SCOPE), scheduled February 7-10 in Orlando, Florida.

SCOPE organizers established the PEA recognition program to recognize innovation aimed at improving clinical trial patient recruitment and retention. Organizers have dedicated the PEAs to Jerry Matczak, who passed away shortly after receiving the first PEA in 2017.

Submissions for the PEA come from various corners of clinical research, including sites, contract research organizations (CROs), e-patient advisors, agencies, startups, and sponsors. Candidates’ applications are reviewed by study participants, industry peers, and a panel of industry experts.

2022 Finalists

inVibe Labs​
TrialPulse: Integrating the Patient Voice to Optimize and Validate Throughout the Drug Development Process​

Built on inVibe’s Voice Research Platform, TrialPulse is intended to help clinical teams systematically and cost-effectively integrate patient insights into drug development processes in six areas:

• patient experience;
• burden of disease
• unmet needs
• trial design
• recruitment asset evaluation
• retention optimization.

It works by virtually recruiting a sample of real patients similar to a study's inclusion/exclusion criteria, providing them with relevant stimuli (e.g., protocol summaries, e-consent forms, recruitment materials), and prompting them to provide their specific thoughts/feedback via inVibe’s proprietary automated voice response (AVR) interview platform. Patient voice data is next collected and analyzed in an interactive, searchable, filterable online portal where sponsors can listen to the responses, share audio clips with other team members, and/or review the high-level executive summary created by inVibe analysts.

Merck​
Back to Virtual Reality: Getting Real about Patient Engagement​

Presented with a pediatric oncology protocol, their team looked to find reasons that would make participation hard, aside from the obvious (children and caregivers are already burdened with their disease). Special populations (i.e. children) in clinical research often bring unique enrollment barriers to operational execution, such as protocol requirements that translate into very long study visits; they aimed to consider how to put patients first and create engaging and age-appropriate activities that allow children and families to pass the time during study visits. Collaborating with a tech partner, they procured virtual reality headsets and used entertaining, calming content to give trial participants an activity to pass the time.

Guardant Health​
Guardant GAP Program: Closing the GAP for Oncology Patients​

Guardant established its GAP program to give patients access to a liquid biopsy (minimally invasive, NGS test) and be matched to clinical trials across sponsor companies, addressing an unmet medical need in the community and reducing time to treatment. The GAP program fulfills this need while helping sponsors identify potential patients and reduce trial timelines.

Infiuss Health​
Connecting Africans to Global Clinical Trials​

About 1.4b Africans (a highly genetically diverse population) are left out of clinical research and trials, which leads to efficacy variations in African patients when dosed with drugs tested on mostly white, European patients. Infiuss is aimed at helping pharma, health providers, and researchers identify new patients, participants, and sites for clinical research and trials across Africa. The company offers software designed to facilitate recruitment and engagement by sourcing eligible and diverse patients and participants for trials, reportedly in under 60 minutes with 98% accuracy.

Tryl​
Empathetic Patient Engagement System from Tryl​

Tryl’s Empathetic Patient Engagement System guides participants through a compliance-ready journey, increasing adherence while lowering dropouts. The engagement system responds to and anticipates the needs of trial participants and researchers. It reportedly goes beyond conventional ePRO, sCOA, and eDiary systems by combining consumer-grade UX, applied behavioral science, passive data collection, dynamic personalization, predictive analytics, and headless architecture.

Award judging

At SCOPE, each finalist will be given two minutes to deliver a presentation outlining their concepts, followed by a question-and-answer session with the judges. Submissions are reviewed for:

• improvement of access, awareness, and participation in clinical trials
• creativity, innovation, and regulatory and legal compliance
• ability to improve diversity, equity, and inclusion.

Additionally, judges are on the lookout for nominees that increase engagement from current, former, or new study participants. The 2022 PEA judges include:

• David Sall, president and CEO of Patient Enrollment Advisors (and co-creator of the PEA)
• Kelly McKee, vice president of patient recruitment and registries with Medidata (the other PEA co-creator)
• Micah Lieberman, executive director of conferences with the Cambridge Healthtech Institute (CHI)
• Kimberly Richardson, research advocate and founder of the Black Cancer Collaborative
• Michelle Crouthamel, head of digital science for AbbVie
• Irfan Khan, CEO of Circuit Clinical
• Gretchen Goller, senior director and head of patient recruitment/clinical development operations with Seagen
• Alicia Staley, vice president of patient engagement with Medidata (and trial volunteer/cancer survivor)

The 2022 Summit for Clinical Ops Executives is scheduled February 7-10, in Orlando, Florida, and online. For more information or to register, visit www.scopesummit.com​.​