By Deborah Borfitz 

March 3, 2021 | For the opening plenary session of this year’s Summit for Clinical Ops Executives (SCOPE), Pfizer’s Demetris Zambas, Nicholas Kitchin, Helen Smith, Beth Paulukonis, Darren Cowan, Brett Wilson, Ralph Russo, and Liping Zhang offered specifics on the one-team mindset and “removal of white space” that helped bring a COVID-19 vaccine to market in record time without cutting corners. An emotionally stirring video paid tribute to the nearly 44,000 trial volunteers whose courage exemplified the company’s Science Will Win mantra. A trusted partner model co-designed with investigative sites, agile approach to database builds, and leveraging of geographic capabilities were on the list of repeatable strategies that were flawlessly executed for the mRNA vaccine in under a year. 

Yet two more Pfizer executives, Oriol Serra Ortiz and Sandra Amaro, homed in on the company’s “layered intelligence” approach to recruiting the right sites with the right attributes. Site intelligence profiles integrate historical KPIs, competitive intel, real-world data, and local know-how so study teams pick well the first time—and trial participation opportunities extend to communities where minority populations live. Meeting people where they are at, building culturally sensitive materials and content, and being transparent about expectations and roles are key considerations at the execution phase. 

GSK’s Luis Garcia-Gancedo presented on a pair of published use cases where digital biomarkers were implemented in rheumatoid arthritis (RA) and (ALS) studies, the learnings from which have informed their use in more recent trials. For the ALS study, actigraphy data from a chest sensor worn by participants an average of 18 hours daily over three days showed moderate correlation to a standard functional rating scale, but no robust conclusions were possible due to the small sample size and variable patient compliance with the protocol. Patients in the RA study used a smartphone app measuring functional outcomes based on their performance of wrist rotations and a walking test, which associated with their self-reported level of pain.

A patient burden algorithm designed to capture how a participant perceives, interprets, and experiences a clinical trial was the focus of a talk by AbbVie’s Allam Fakhoury. The scoring system was developed in collaboration with Inspire and ZS, with input from hundreds of patients, and revealed the importance of limiting the time required to complete questionnaires, providing transportation to study sites and reimbursement for parking costs, offering food and drink during study visits, making trial data available once a study is completed, and expressing gratitude for their contribution to science. 

During a live panel discussion on integrating data and patient insights into early trial design, Bayer Healthcare’s Michelle Shogren highlighted the importance of listening to the patient voice throughout the life cycle of a study. Appian’s Evi Cohen stressed the need to connect technology to the way people work, while Pfizer’s Melanie Goodwin talked about the value of combining protocol simulation with patient insights. Daniela Franschman reports that Bayer Pharmaceuticals will more often be conducting participant exit interviews, and Kafayat Babajide says Janssen has developed a portal where it receives feedback from patients in real time. Fakhoury notes that AbbVie is looking at how to automatically capture data from electronic health records once a trial ends in a “tokenized” fashion to protect patient confidentiality. 

A presentation by GSK’s Eddie Dukes and Stephen Gardiner covered fast-tracked development of a COVID Control Tower providing a “single source of truth” across the clinical ops portfolio so trial leaders could see how studies were progressing and where mitigation was required due to pandemic-related disruptions. The platform answers five critical questions in one location and is now an enterprise solution for reporting and analytics, risk management and portfolio-wide decision-making. It became a minimum viable product in just three weeks and reached full maturity last October. 

Hugo Health Co-founder Harlan Krumholz, M.D., spoke about how remote methodologies and engaging participants as partners can add efficiency, speed, and new sources of information to the research ecosystem as well as make the study experience relational and delightful. He imagines the creation of “virtuous partnerships” where the exemplary nature of technology improves over time, innovation is viewed as a competitive advantage, and study sponsors have proven worthy of the trust of participants because they have aligned along areas of mutual interest.   

Historical trial data (HTD) can be leveraged to accelerate the development of life-saving treatments, justify proposed endpoints, enhance safety signal interpretation, and reduce participants’ exposure to a placebo versus active treatment, according to Amgen’s Matthew Gribbin, in a session made possible by TransCelerate. In addition to its HTD-sharing initiative promoting reuse of clinical trial data, TransCelerate has been working closely with regulatory agencies in delineating the benefits and risks of the innovative methodology, and the appropriate selection of historical data to minimize the potential for bias or inflated type 1 errors. Two use cases were shared, including one where HTD was used to explore a new disease state and power the control group and another that provided support for a clinical program and generated $1 million in savings. 

At an end-of-day discussion on outsourcing strategies and processes, panelists shared their struggles in reconciling study financials with sites while maintaining those important relationships, as well as how to handle pandemic-associated costs related to patient stipends, PPE, and home care visits with unknown fair market value. Geri Masessa reports that Bayer Healthcare competitively selected DrugDev (an IQVIA company) to automate payments to sites, replacing a crisscross of Excel spreadsheets with the simplicity of a one-stop portal tracking what’s owed and paid on studies.