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Clinical research is an integral part of improving patient care and advancing medical knowledge, but over the last several years, clinical trials have continued to become increasingly complex. This increase in trial design complexity has added additional burden on clinical research sites, many of which are already facing unprecedented resourcing issues, enrollment challenges, increased technology burden, and more. As the industry strives to improve patient outcomes and advance medical knowledge, it is important to recognize the main challenges clinical research sites are facing in this stressed clinical landscape so we can implement more effective strategies and run more efficient trials in the future.
To better understand the current site landscape and the top challenges sites are facing, WCG created the 2023 Clinical Research Site Challenges Survey Report, in addition to recommendations for sites, sponsors, and contract research organizations (CROs) to better address study needs and the needs of the sites conducting those studies.
Survey Background and Demographics
In February-March 2023, WCG surveyed more than 500 U.S.-based clinical research sites, including academic medical centers, community hospitals, health systems, physician practices, and independent sites. Our objective was to gain and share insights that would empower the clinical research community – sites, sponsors, CROs, and service providers – to address industry challenges and ultimately help sites deliver trials more effectively.
Top Site Challenges in 2023
The big question we asked sites in our survey was “what are the top three issues impacting your site today?” Here are the results:
- Site Staffing and Retention – 63%
- Patient Recruitment and Enrollment – 48%
- Study Start-up – 36%
- Complexity of Clinical Trials – 36%
- Long Study Initiation Timelines – 23%
- Physician Interest and Engagement – 19%
- Technology – 18%
- Trial Financial Management – 18%
- Patient Access Challenges – 16%
- Remote Monitoring – 9%
- Decentralized Trial Components – 7%
- Ethical/Regulatory Review – 5%
Staffing/retention (63%) and recruitment/enrollment (48%) remain the top concerns at research sites in 2023. While the impact of The Great Resignation has lessened, a site’s decision to complete feasibility surveys for new trial considerations is largely dependent on having the resources to efficiently conduct those clinical trials. Additionally, enrollment in existing and new clinical trials remains closely tied to site resourcing levels.
In addition to the challenges listed above, trial complexity is frequently mentioned as a major burden to sites, ranking third in this survey (36%). The complexity of trial designs is being closely reviewed at research sites and cited as a reason to forego opening specific clinical trials with multiple arms or complex trial designs (e.g., adaptive, basket, umbrella trials), favoring studies with simpler protocol designs.
Study start-up also ranks in the top issues of sites, at 36%, tied with trial complexity. The scarcity of research professionals extends beyond the clinical research coordinator role to other areas of expertise, including research administrative functions essential to trial start-up – specifically those involved in coverage analysis, budgets, contracts, and regulatory submissions. Gaps in immediate access to these essential study start-up functions continue to contribute to longer activation timelines at sites, causing additional trial delays. Moreover, sites acknowledge that trial start-up is impacted by additional study review processes put in place to determine which trials will even be considered for activation.
How to Address These Site Challenges and Run More Efficient Trials – Recommendations for Sites
What can research sites do to address their key challenges? Clinical research, at its core, is an industry that promotes change by advancing science. To flourish, research sites must continue to adapt, but more importantly, intentionally innovate. Research teams need more people highly skilled in specialized research functions along with predictable study activation timelines and enhanced physician engagement.
Ten Ways Clinical Research Sites Can Address Their Key Challenges:
- Focus on the participant experience throughout the recruitment, enrollment, and retention process.
- Utilize and invest in technology systems that can improve existing workflows and streamline research operations.
- Leverage data and technology to optimize participant recruitment, enrollment, and retention.
- Implement diversity, equity, and inclusion (DE&I) strategies into your participant recruitment, enrollment, and retention processes.
- Document, simplify, and standardize workflows and processes that are conducted regularly.
- Identify where the gaps exist in your research workflows; determine what must be done onsite vs. what can be outsourced.
- Establish clear communication at your site and ensure that site staff members are aware of their specific roles and responsibilities for each trial.
- Invest in ongoing training, education, and networking opportunities for site staff.
- Build strong relationships with sponsors and CROs to enhance communication and transparency.
- Adopt a quality management system and identify best practices to ensure regulatory requirements are met.
How WCG Can Help
How does WCG help clinical research sites run their trials more efficiently? WCG partners with research sites to provide comprehensive, integrated solutions designed to address the primary challenges sites face in effectively launching, managing, and growing a research program. Our expert-driven processes and cutting-edge technology help sites enhance efficiency, reduce administrative burden, and improve financial results. These solutions include:
- Study Start-up Solutions – Coverage Analysis, Budgets, and Contracts
- Institutional Review Board and Institutional Biosafety Committee Solutions
- Financial Management Solutions – Accounts Receivable and Claims Review/Adjudication
- WCG Site Network – Study Identification and Administrative Support
- Site Operations Solutions and Data Entry Support
- Patient Recruitment, Enrollment, and Retention Solutions
- WCG eResearch Clinical Trial Management System
- Diversity, Equity, and Inclusion Solutions
- Study Advertising
- Avoca Quality Consortium