After the disruptions to the clinical research field in 2020 and 2021, many looked forward to 2022 as a year of “getting back to normal.” Instead, we found that many pandemic-associated changes have forced us to look at a lot of issues through a new lens.

Clinical trials continued to evolve in response to new therapeutic advances, with more protocols incorporating complex design elements, earlier evaluations of efficacy and an increasing number of platform studies to move potential drug candidates to decisions more quickly.

2023 looks like it will be just as exciting. In this first of three excerpts from the WCG annual report on trends and insights, experts from a variety of areas talk about what they’re watching, expecting and looking forward to in 2023.

Perspectives on Clinical Research Sites in 2023

Sandra Smith, RN, MSN, AOCN, Senior Vice President, Clinical Solutions & Strategic Partnerships, WCG

To combat the tumultuous conditions of the industry, research organizations have been forced to look internally to identify operational efficiencies over the past two years, and institutional reconfiguration will continue to evolve in 2023. Centralization of research services, embedding enabling technologies and establishing research partnerships — both with service providers and with sponsors — will remain key themes in addressing site capacity challenges. Many noninstitutional research sites will aggregate into networks to achieve higher operational performance.

Human capital remains critical, and the skillset for research expertise will continue to be in high demand in 2023. Sites are reporting fewer vacant positions, but turnover will persist and training newly hired, less-experienced research personnel will remain critical. Sponsor-supported staffing augmentation solutions will be key to trial conduct for many organizations.

Oncology will endure as a dominant therapeutic area in clinical research in 2023. Approximately 50 percent of all clinical trials started in 2022 were in oncology, with more than 1 million patients (about the population of Delaware) needed to complete those open trials, according to WCG’s Knowledge Base. Increasing trial complexity will challenge sites with narrow inclusion/exclusion criteria, multiple study arms (i.e., 19 to 20 percent increase in four- to five-arm trials in oncology) and an increasing number of amendments per clinical trial (i.e., 57 percent increase since 2017).

Declining average rates of enrollment per site and the need for increased enrollment diversity will accelerate sponsor interest in opening trials at community-based sites and in supporting new investigators/sites. Rapid trial activation, bringing trial access to new participant populations and utilization of decentralized trial components will be critical components for trial success.

Redesigning the Clinical Research Landscape

Jamie Harper, MHA, Director of Site Engagement and Relations, WCG

In 2023, clinical trial access and improving participant diversity will remain key concerns within the clinical research and healthcare community. Compounded by the number of physician investigators continuing to decrease, the industry will be tasked with developing solutions to ensure scientific medical advancements continue while maintaining support for these diverse populations. Identifying and supporting new physician investigators at research sites, especially those ingrained in the community setting, is critical to offsetting these concerns and accelerating advancements.

Redesigning the clinical trial landscape to mitigate these challenges and create an environment that allows engaged community physicians to provide clinical trial access to the communities they serve is a must. Engaging community sites and physicians who may not have previously considered clinical research as an option presents a path toward addressing the concerns of clinical trial access and participant diversity. However, this pathway will require the clinical research industry to provide support for the tools and mentorship needed to successfully conduct compliant clinical trials.

The new environment will require evolution of the current collaborations between sponsors, CROs, third-party clinical research vendors and experienced physician investigators. This collaboration’s success will depend on a shared focus on cultivating a redesigned clinical research landscape through inclusion.

Diversity Strategies and Empowering Sites to Support Them

Katherine Cornish, PhD, PMP, Associate Director, Patient Advocacy & Clinical Trial Diversity, WCG

As the FDA moves closer to finalizing the current draft guidance on establishing diversity plans to improve clinical trial participation of underrepresented racial and ethnic populations, it becomes imperative to ensure that the strategies outlined in these plans are translated to the site level in intentional and actionable ways (CenterWatch Weekly, July 25, 2022).

Sponsors must empower their sites by providing pragmatic strategies that site staff can use to effectively identify, engage, enroll and retain underrepresented populations. This should be done through the creation of site-focused diversity plans that tie into the overarching diversity plan. Key partnerships with advocacy groups, community-based organizations and other similar entities outlined in diversity plans at a national level should be translated to individual sites locally. Sponsors must also provide the necessary support to ensure these strategies can be enacted by their sites.

Additionally, these strategies must be identified, documented and mobilized early in the trial lifecycle; they must be thought about proactively rather than as rescue methods. Sponsors should reach out to the FDA to discuss their diversity plans as early as possible — certainly prior to study start. Thinking about these approaches early can also ensure that the necessary support is preemptively budgeted at the site level, allowing sites to initiate local advocacy and community engagement efforts from the start. This ensures that sites are prepared and ready when recruitment begins and can enact their action plans from first patient to last visit.

The FDA’s Recent Notice of Proposed Rulemaking and Guidance

Dave Borasky, MPH, CIP, Vice President, IRB Compliance, WCG IRB

The year 2022 ended with two interesting developments for IRBs and industry on the FDA front. First, the agency published two proposed rules intended to bring greater harmony between the FDA regulations for human subjects research and the Common Rule regulations that apply to federally funded research that is not subject to FDA regulation (CenterWatch Weekly, Oct. 3, 2022). While this harmonization was expected — it was mandated by the 21st Century Cures Act in 2016 — it was not clear when the proposed rules would be issued. The proposed harmonization on issues of informed consent requirements and the use of a single IRB for multisite trials will improve the review and implementation of clinical research in 2023 and beyond.

The second late-year offering from the FDA was the draft guidance Ethical Considerations for Clinical Investigations of Medical Products Involving Children (CenterWatch Weekly, Sept. 26, 2022). Through this guidance, the FDA has finally provided clear direction on the expectation that IRBs use component analysis when reviewing research with children that includes multiple research-related interventions or procedures. Component analysis, which has the IRB assess each study procedure (and each study arm), considering the risks and benefits, is often confusing to sponsors. The guidance also provides direction on the FDA’s thinking on what constitutes a “minor increase over minimal risk” (21 CFR 56.102(i)), which is not defined in the regulation but represents an important threshold for reviewing research involving children, particularly in the context of component analysis.

Read the full WCG 2023 Trends and Insights report here: https://bit.ly/3GltdQ8.

Join WCG experts in a panel discussion of 2023 trends and insights in a Jan. 24 webinar. Register for the free webinar here: https://bit.ly/3iggwOK.