By Deborah Borfitz

March 4, 2021 | At day two of the Summit for Clinical Ops Executives (SCOPE), a keynote presentation by Janssen’s Darren Weston explored how the COVID-19 pandemic effectively redoubled the company’s culture of innovation. Among the lessons learned were to accept risk, act with more urgency in implementing innovation, manage organizational fatigue, enable knowledge exchange across therapeutic areas, and embrace analytic risk-based monitoring. By being more “change agile” and “change resilient,” patient enrollment into Janssen-sponsored trials was 20% higher during the first half of 2020 than the same period a year earlier since only a fraction of studies had to be paused. The Trials2You (decentralized clinical trials) program will remain and continue to evolve post-pandemic, he says.

Bristol Myers Squibb’s Shwen Gwee, Aetna’s Lou Sanquini, and SalesForce’s Gary Gabriel tag-teamed for another keynote looking at the new players and innovators in clinical trials—specifically, CVS Health (which owns Aetna) and Salesforce. CVS Health has converted 1,300 MinuteClinic locations into HealthHUBs supporting clinical trials, virtual or otherwise, in addition to helping people manage chronic health conditions. As part of Operation Warp Speed, it also funneled individuals testing negative for COVID into vaccine trials and those testing positive into relevant treatment trials. Gabriel reports that Salesforce built a patient retention platform for Janssen to engage consumers before and long after their trial participation and a clinical ops platform for AbbVie that consolidates six pre-existing systems into one. Salesforce also plans to partner with next-generation cell and gene therapy developers while their drugs are in trials and after they hit the market. 

Xia Wang shared the experiences of AstraZeneca in deploying real-world evidence (RWE) in trials across broad therapeutic areas, noting rapid adoption of federated electronic health records to inform clinical study design and protocol optimization as well as a strong desire to link RWE with insights from other data sources to help identify new opportunities and targets. Interest is also high in piloting machine learning and artificial intelligence applications with RWE to identify diseases early and prevent their progression. The company most recently kicked off a DAPA-MI study in Sweden and the U.K that integrates traditional, pragmatic, and innovative study design elements with the goal of minimizing patient and investigator burden while producing RWE of efficacy beyond what has been generated by randomized controlled trials, she says.

Her colleagues Michele Teufel and Kevin Sooben separately presented on AstraZeneca’s newly launched Unify app that was co-developed with patients and walks them step by step through the study process. The co-creation process involved 119 patients as well as 110 healthcare professionals and 77 CRAs. After plotting out the highs and lows of patients’ journey, such as muddling through informed consent documents or anxiously waiting to learn if they passed clinical screening procedures for research eligibility, prototypes of the app were tested with end users. Thanks to their input, information on upcoming appointments is readily available on the home page and support is divided into sections specific to study and technical issues. 

Merck’s Rakesh Maniar and Bristol Myers Squibb’s Joe Dustin, co-leads of TransCelerate’s eSource workstream, teamed up for a presentation on a decentralized hybrid model for remote monitoring that makes use of the tools and tactics developed through that initiative. A preliminary analysis of the eSource regulatory environment identifying gaps, differences, and consensus across geographies was recently completed, and a site qualification questionnaire is also available for sites to self-assess where they fall on the eSource maturity continuum. This year, the eSource workstream team will be working on a lab implementation guide pilot project with the Society for Clinical Data Management for pulling data from electronic health records to pharma systems and converting the information to CDISC standards. It will also be collaborating on a multi-stakeholder Vulcan accelerator project, endeavoring to allow seamless information exchange of clinical research and healthcare data via the HL7 FHIR standard.