Merck Maintains Human Touch In AI-Assisted Patient Recruitment And Education

A conversation with Jen Sheller, senior vice president and head of global clinical trial operations, Merck

Everyone understands the plight of an Excel tracker: simple and streamlined execution in singularity, but an unwieldy monster in any scaled-up scenario. That was certainly a reality for one of Merck’s clinical operations teams grappling with study start-up. It was the perfect place to implement AI with a little human guidance, and it became one of many ways in which the pharma giant looks to automation to complement its employees’ expertise.

In this Q&A, Jen Sheller shares how Merck’s “Zero Gravity” program and human-enabled AI are streamlining clinical research while honoring the human insights essential for trial success. She also reflects on the company’s recognition for efforts in diversity, accessibility, and patient engagement — demonstrating that meaningful innovation in clinical trials is as much about the patients it serves as it is about the scientific breakthrough it’s trying to achieve.

Clinical Leader: What tools, technologies, and partnerships have you leveraged to build a more connected, site-focused clinical trial ecosystem?

Jen Sheller: One example is our clinical trial technology modernization program, “Zero Gravity.” Previously, we operated in a technology environment with heavily customized, siloed systems that required significant manual effort. Despite our clinical research progressing, these operations were tedious, and we saw an opportunity to increase efficiency and speed through innovation.

We’re now transitioning to an integrated platform across our trial ecosystem. This enables greater data transparency, removes redundancy (and, thus, the associated reconciliation efforts), and drives standardization to enable greater automation and AI.

As an example, one component of this platform is how we work in study start-up. Before, our teams managed with more than 50 country-specific Excel trackers and email updates to a workflow tool with the country specific requirements built in, with automation and transparency across functions.  Another component of the platform automates the collection of local lab normal ranges, which reduces manual labor at the site and alone is reducing data queries by 5%-10%. This type of shift enables clinical researchers to focus on what matters most — patients, not administrative tasks.

Through the Zero Gravity program, we’re modernizing our trials by moving from fragmented applications to an integrated platform, beginning with Phase 1 studies and now moving into late-stage trials. The goal is to simplify processes, remove manual steps, and ultimately accelerate the delivery of lifesaving medicines and vaccines.

Pick your favorite tool or tech mentioned above. What is it, and what gets you so excited for its potential?

Technology, when enabling an effective process (these must go hand in hand), can positively impact the clinical trials landscape and the patient experience. We initially highlighted Zero Gravity, but I also want to highlight how we’re utilizing human-enabled AI to better inform site selection and patient matching for clinical trials.

Currently, we’re working with partners to integrate AI into EHRs at clinical trial sites. This integration will help match potential patients to complex trial eligibility criteria — something that traditionally takes hours for site staff to do manually. By leveraging AI, we are focused on accelerating trial enrollment, reducing the burden on site professionals, and helping reach the right patients faster. It’s a powerful example of how technology can drive both efficiency and equity in clinical research.

What advice would you give to sponsors looking into this or a similar approach? What should they know about the research, selection, and rollout?

Tools, including AI and automation, only work when they fit seamlessly into existing and appropriate workflows, making life easier for sites, staff, and patients rather than adding complexity. Our philosophy is to evaluate whether existing workflows are fit for purpose and proportionate to risk (as highlighted in ICH E6 R3) and then assess how to leverage technology for efficiency and effectiveness. We use AI and automation to complement human expertise, allowing our researchers to deliver faster insights without sacrificing the quality or safety of the research process. It’s crucial to bring sites and partners into the process early to design with the user experience as a priority. The best solutions come from collaboration, not top-down planning.

Earlier this year, Merck was awarded the 2024 Sponsor of the Year award at the 2nd Annual Black Women In Clinical Research. Understanding your desire to make trials inclusive for all, how did it feel to earn this award, and what efforts do you think contributed to the acknowledgment?

We were honored to receive the 2024 Sponsor of the Year award at the annual BWICR conference, and we recognize that more work is needed to help create a future of healthcare that is inclusive and representative of all communities.

Our company has taken concrete steps to improve representation in our research by working with community-based organizations, institutions of higher education, and professional groups to expand our outreach to meet and engage with volunteer participants. We also apply insights from a community advisory board to incorporate the voice of the patient in our site and patient engagement methods.

We focus on the future of the clinical trial workforce and STEM education to ensure a steady pipeline of talent to cultivate the next generation of scientists and clinical researchers. At Merck, we are part of OneTen — a program focused on driving a skills-first movement to unlock career opportunities for talented individuals who have not completed a four-year degree. About 50 companies formed a coalition dedicated to create 1 million careers for Black talent in America over 10 years. Merck’s Global Clinical Trial Operations organization is an active participant and has hired nearly 50 employees to support data management and clinical operations activities. It is imperative to have a workforce that is diverse in thought, experience, and perspective — and to take a concerted effort to unlock hidden talent that is often overlooked due to systemic biases. Such diversity is how we'll drive the best science and how we'll work to understand how medicines are impacting all patients.

We also recognize that including participants from across communities is one step, but there are other challenges to participation they may face. Things many people take for granted, such as the cost of a bus fare, can hinder access to clinical trials. This is why we have implemented options to help people overcome barriers. As an example, we work with Suvoda (formerly known as Greenphire), an organization that helps ease transportation barriers for some of our trial participants. We have also implemented health screening opportunities in underserved communities to help ensure equitable access to clinical trials.

Merck also won a platinum award for Best Overall Internet Site and a silver award for Best Mobile Website at the Healthcare Internet Conference. What role does a sponsor company website have in executing a patient-centric approach? How important is a website and mobile website to raising brand and clinical trial awareness, as well as trial enrollment?

It’s a sponsor’s responsibility to ensure the website is accessible and informative for patients, care partners, and HCPs. People may be hesitant about participating in clinical trials; empowering them with information can help dispel myths and encourage informed decision-making. The website provides additional information that may answer questions about safety and help build confidence in the clinical trial process. As we partner with organizations, such as BlackDoctor.org, we connect our website with clinical trial educational sessions to empower patients to identify a clinical trial near them. For patients who do participate in our studies, our website also provides them with plain language summary results.

Our goal is to provide information that will help patients make an informed decision on a clinical trial and to support HCPs in being a trusted source of clinical trial information.

What information, design, or other component of the sites makes them patient-friendly?

We built our website with a patient-first approach. The mobile-first design is intended to make it simple for people to search for information on their phones. Information should be easy to find and to understand, as navigating the clinical trial process can be challenging enough for a patient, care partner, or HCP.

Our content is developed in partnership with a health literacy media team to help ensure the information and resources we provide are accessible to patients and their loved ones broadly.

What recommendations do you have for sponsor companies wanting to make their patient-facing digital assets as useful and valuable as possible?

We recommend listening to patient insights directly to inform the design of digital assets. We regularly meet with patient and community advisory boards to gather feedback and evaluate digital assets with their input to ensure the content and user experience are understandable and accessible.

We also recommend integrating user experience (UX) design experts into any digital tool. This was a core foundation in our Zero Gravity trial modernization program. It is especially important for patient-facing digital assets, as UX design helps make technology accessible across age groups, literacy levels, and cultural backgrounds.

About The Author:

Jennifer Sheller is the senior vice president and head of global clinical trial operations (GCTO) at Merck. Since joining Merck in 2017, Jennifer has held various leadership roles within R&D, including overseeing quality, data management, site monitoring, diversity & inclusion, and North America country operations. She has led R&D integrations for key biotech acquisitions, which led to effective transitions and timely approvals for new innovative medicines. Jennifer has over 25 years of experience in pharma, biotech, and CRO companies. She began her career as a CRA and has taken on roles of increasing responsibilities over the years, including leadership of pivotal R&D programs and defending regulatory inspections for market-approved products. Jennifer has a bachelor’s degree in molecular biology, a Master of Public Health in epidemiology, and has been an Association of Clinical Research Professionals (ACRP) certified professional since 2021.