2024: Familiar Problems & Encouraging Progress

For part 1 of my 2024 recap, I asked various industry experts what stood out to them this year regarding the clinical trials industry. They mentioned significant challenges related to site capacity, enrollment, workforce changes, and trial complexity, but they also seemed encouraged with some of the efforts and emerging solutions that will address these issues.

Jimmy Bechtel, VP Site Engagement, SCRS

In 2024, the clinical research industry showed promising signs of recovery. SCRS’s data reveals that sites worldwide are not only rebounding but also actively positioning themselves to meet increasing demands. Yet, this momentum highlights an urgent need: a rapidly growing gap between available research sites and investigators and the scale required to keep pace with advancing R&D needs.

SCRS insights underline how sites have adapted — many now equipped with better infrastructure, streamlined processes, and enhanced patient outreach strategies. These improvements are essential in responding to current clinical demands, but they only scratch the surface of what’s needed for the future. The accelerated push for novel therapies, personalized medicine, and emerging global health priorities is dramatically expanding the industry’s scope. To achieve sustained progress, the field must prioritize supporting site growth and invest in developing and retaining clinical research investigators.

Collaborative action among industry stakeholders remains essential. Partnerships across pharmaceutical companies, CROs, and clinical sites must focus on solutions to cultivate a larger investigator pool and broaden site capacities. SCRS remains committed to guiding this journey, fostering the collaboration needed for sites to not only recover but thrive in this new era of clinical research.

As 2025 approaches, we at SCRS are energized by these signs of resilience while staying focused on meeting the growth demands that will shape the future of clinical research. Together, we are paving the way for a stronger, more sustainable foundation for the industry.

Robert Goldman, Head of Clinical Operations, Contraline

One surprising and recurring trend in the clinical trial industry has been the wave of layoffs and restructuring, particularly within large CROs and pharmaceutical companies. This shift, often driven by economic pressures and the increasing costs of drug development, has led to a leaner workforce and, in some cases, a loss of experienced talent. Such consolidations can lead to bottlenecks, impacting timelines and quality control as organizations are forced to stretch limited resources across multiple projects. While companies aim to increase efficiency through mergers and partnerships, the reality often results in reduced oversight and support for individual trials, raising concerns about data quality and regulatory compliance. For smaller biotech companies, this trend is especially concerning; with fewer available CROs and support networks, they face greater challenges securing experienced partners and maintaining the resources necessary for successful trial completion. As a result, there is a growing emphasis on innovative oversight solutions, like “Fractional Oversight Management,” which can help fill these gaps by offering specialized expertise on a flexible basis. The industry’s evolving landscape underscores the importance of adaptable, scalable solutions that ensure trials remain both cost-effective and scientifically rigorous in this period of uncertainty and change.

Jim Kremidas, Adjunct Graduate Faculty Member, Wake Forest Clinical Research

The acquisition of dedicated clinical research sites has continued to grow in 2024 leading to larger multisite corporations. Additionally, the use of these multisite groups in clinical trials has grown significantly since 2021. According to L.E.K Consulting, the percentage of sponsors and CROs contracting with multisite organizations increased across all trial phases, with Phase 3 trials seeing the most notable rise, from 17% in 2022 to 31% in 2023. While complete data for 2024 is not yet available, anecdotal evidence suggests this upward trend has continued.

This growth highlights the clinical trials industry's challenges and the value dedicated multisite corporations can bring in addressing them. Individual sites often face hurdles such as patient recruitment, retention, and managing the increasing complexity of clinical trials — an issue that has led many to scale back their participation. In contrast, consolidated multisite businesses offer sponsors and CROs a more robust solution: streamlined operations including contracting and start up, consistency across multiple locations, access to larger, more diverse patient populations, and the infrastructure to ensure high-quality data collection and reporting. As trial complexity and reporting needs increase, they are proving to be vital for sponsors and CROs, which is evident in this year's trend toward their increased use.

Wendi Lau, Sr. Dir., Clinical Development Operations, Abbvie

One of the top complaints from study sites is the increasing amount of technology and systems we are using within a clinical trial. The complexity of keeping information updated across systems creates a bottleneck in information flow and reduces efficiency. Sponsors and vendors should be focusing more on simplifying and improving how study sites manage their day-to-day interactions with the various vendors and technology we provide to support clinical trials. While we have an abundance of technological interventions available to improve efficiencies, without a way to integrate or connect the various tools available, we continue to add to the problem.  I was encouraged by advancements in this space with options being created to help improve the ecosystem our study sites might use to manage a clinical trial, offering single-sign-on potential, perhaps even a dashboard to show outstanding or upcoming tasks across the various systems. A truly customer-centric approach allows our site staff to focus on the critical activities related to study conduct rather than the burden of managing the onslaught of technology we keep adding to be more “customer centric.” I am hopeful we continue to move toward this type of approach, and that the owners of various technology solutions are open to the opportunity of filling a major gap and improve the efficiency of conducting clinical trials.

Carrie Lewis, Executive Director, Clinical Program Optimization, Endo

As the industry evolves to accelerate advances for patients, it’s interesting how past practices are often revisited and then improved upon to meet today’s needs. The current hot topic — Full-Service vs. Functional Service Provider (FSP) — is one of these recurring discussions. As companies evaluate these options, I believe they must find what aligns with their culture and needs, with a hybrid approach often being the most effective. Over time, I have discovered new benefits of the FSP model, even after years of working within it. I have seen firsthand how a strong FSP can significantly improve timelines and budgets, creating efficiencies that speed advances to patients, so it’s no surprise this model is being reconsidered. 

Reflecting on 2024, I am most proud of advocating to grow the ranks and expertise of clinical service providers by bringing research-naive trial sites into the fold, hiring people new to the industry, and creating more opportunities for junior staff. It’s important to give opportunities to research-naïve sites and individuals as they bring a variety of experiences and perspectives, which help to strengthen and diversify our clinical trial network. This concept of giving new sites and people a chance seems simple, yet it is rare. I hope our industry will shift its focus from just reviewing people via their CVs and years of experience to a more holistic approach that takes into account how they’ve persevered to attain their goals. Our industry-specific skills can be taught, but work ethic and passion to drive advances cannot. We must remember that. 

Ted Trafford, Director of Business Development, Probity Medical Research

Looking back at 2024, one big thing stands out to me — slow/lack of enrollment in clinical trials remains the biggest issue we face as an industry. However, there is little progress on this. The industry might even be moving backwards in this area. To make significant progress, there needs to be a much better understanding by all stakeholders of the issues that affect enrollment in clinical trials. There must be leadership at sponsors and CROs enabling strategies to tackle both the short term, study specific enrollment issues and the larger, long term, systemic issues. Study-specific solutions are being developed. The AI-powered, unstructured data search tools to review EHRs and match potential candidates with protocol eligibility criteria are interesting and worth keeping an eye on as they mature. Unfortunately, little work is being done on the long-term issues. Other priorities are the focus, with resources being poured into capturing more data faster. The participant journey is discussed, but not understood. The impact that site motivation has on enrollment is discounted and factors not addressed. Lack of enrollment is typically seen as a study-specific site issue, but unless sponsors and large CROs step up and dedicate teams to study and address the bigger crises in enrollment, the situation will not get better.