Contributed Commentary by Mark Brown, IQVIA

February 4, 2022 | It is no surprise that the global pandemic has created challenges in allowing trial sites to conduct research focusing on efficiency and quality care. However, it has also brought to the forefront the long-established systemic issues that site teams face in trial operations and related patient care and staff burdens. Ongoing issues such as increasing administrative responsibilities and timely patient onboarding make it difficult for site teams to focus more of their time on the bigger picture of high-quality patient care.

With the urgency of maintaining trial continuity through COVID-19, the industry had an opportunity to dive deep into out-of-the-box thinking. With speed and agility to elevate innovation in site support, startup, and management strategies and execution, the sponsors, clinical research organizations (CROs), and sites made a tangible difference in day-to-day efforts of the site teams to ultimately ensure that research, discovery, and high-quality patient care were on track with increased efficiencies and shortened timelines.

Now, the industry has a chance to look back, reflect, and integrate what worked well in site startup and management into future trial programs, especially as site operating models are shifting.

Building Ongoing Relationships

As sponsors consider how to plan and execute effective and agile site strategies to maintain quality research and ensure patient care is always the number one priority, the first step is for sponsors to see trial sites and teams as valued partners in the trial process. If sites are viewed as one-off or single-project teams, it can be difficult to quickly adapt to evolving roadblocks with innovative (and practical) solutions. Strong and ongoing relationships with sites and related patient groups were critical during the pandemic and for future unanticipated challenges.

During the initial months of the pandemic, having a bird’s eye view of sites and knowing their existing capabilities through ongoing discussions was key to ensuring trials remained on track where possible. These would be the “go-to” sites to maintain trial continuity for patients in need, including efficient patient enrollment and engagement management. Going one step further (and quickly), it was vital to know and understand what staffing and resource concerns sites needed support with at the time and potentially for the long haul.

Offering a Helping Administrative Hand

During the pandemic, as sites re-opened and as patient interest in trial participation increased, site staff were faced with an influx of trial onboarding. This is a great "problem" to have, but staff numbers were low during that time due to the initial months of shutdown and limited site accessibility for patients. COVID-19 will not be the last global roadblock we will face, and sponsors will need to account for similar situations in future trials.

To help reduce site staff loads and trial onboarding delays, sponsors provided overwhelmed site teams with on-site and remote support to minimize administrative work, including:

• Assistance with the Study Coordinator in the day-to-day, time-consuming tasks involved in running a study
• Performing initial outreach calls to trial subjects for scheduled site visits

Site service experts can also provide the appropriate technology and data expertise to aid with site startup processes, database lock to-dos and timing, and integration of decentralized trial (DCT) solutions to help with site initiation and close outpatient visits. In some cases, through a mix of experts and tech-enabled solutions, entire engagement campaigns were made to appear as if they came directly from site providers to engage with interested patients while reducing site team times in onboarding.

Leaning on sponsor funding for this on-site and remote support can also reduce some of the financial burdens, especially as the development landscape grows and brings associated complexities. Staff can shift their focus to patient-facing tasks and oversight to enhance the patient’s experience and care, helping to ensure better engagement and retention and quality outcomes.

By maintaining agile site support, sponsors and site teams can easily integrate support services when needed and pull back when staff can return to acceptable workloads without sacrificing quality care.

Patient Identification Through AI/ML-Based Analytics

Trial recruitment always starts with a site's patient databases. Still, to engage additional patients, sponsors can consider using healthcare data assets and modeling algorithms with artificial intelligence and machine learning (AI/ML) to develop a direct-to-patient (DTP) recruitment model. By widening patient identification beyond a site's database, sponsors and partner CROs can execute hyper-targeted multi-channel campaigns, including social media and pharmacies, aiding sites with limited resources and staffing while expanding patient pools who may then turn to these sites for ongoing care.

Through this new source of incoming patients, sites will see more of various patient populations—some locally and others potentially participating via DCT elements, depending on the trial design. These efforts can help make trials more accessible and inclusive of traditionally underrepresented and underserved populations, a key priority for the industry. Understanding that these patients are more likely to trust and engage with community physicians with whom they identify, one way to improve diversity in trials is to support and develop sites with diverse study investigators. At the earliest stages of trial planning, a proactive strategy is needed for sponsors, and CROs are essential to help site teams reach these communities in their recruitment efforts.

It is also worth noting that in aiming to meet patient needs, ensure inclusion and retention, and increase operational efficiencies, DCT solutions can be integrated into trial design. However, it is also critical to offset additional burdens for site teams. Required staff training around DCT solutions and related changes in processes, such as remote monitoring, need to be considered and addressed by the sponsor in the early stages of planning to limit added burdens on sites.

COVID-19 has alerted sponsors and partners to the systemic and unanticipated challenges impacting site teams and collective efforts to provide quality patient care. As sponsors and site teams work together to reimagine site startup and management strategies for future trials, innovation in approaches will focus on tech-enabled solutions and always require the human element to make a tangible difference in reducing burdens placed on site teams for successful clinical development.

Mark Brown is Vice President, Global Patient and Site Solutions at IQVIA. With more than three decades at IQVIA, Mark has touched on several areas of expertise in clinical research. From his initial role providing user support and training through the Information Technology group in 1990, Mark transitioned to the Clinical Data Management group, where his initial responsibilities included clinical documentation and NDA preparation. Those responsibilities expanded until he served as Head of Data Management for the Research Triangle Park office. Most recently, Mark’s remit expanded to the recently formed Global Patient and Site Solutions, which includes the Patient Recruitment Operations team and Avacare, IQVIA’s U.S.-based site management organization. In 2020, Mark led the creation and launch of a service to support research sites by addressing flexible staffing needs due to dynamic workloads due to large COVID-19 vaccine research trials and related staffing shortages. This led to placement of more than 600 research staff in less than six months. He can be reached at mark.brown@iqvia.com.