Could Consolidating Independent Sites Into Site Networks Be The Research Revolution We Need?

By Mark Scullion, CEO, Atlas Clinical

The consolidation of independent clinical trial sites into larger, integrated networks holds significant implications for patients, sponsors, CROs, clinical sites, and investors. If done well, consolidation will pave the way for a more effective, patient-centric, and sustainable future in clinical research.

The Initial Drivers Of Research Site Consolidation

The COVID-19 pandemic revealed and intensified operational challenges within clinical research¹. As an example, a concerning 70% of investigative site staff reports that conducting clinical trials has become much more difficult over the past five years².

The challenges facing the industry today might be considered circular. Protocols are becoming more complex, patient populations are more difficult to find, costs are rising, and operational delivery is becoming more demanding. Meanwhile, industry leaders introduce innovative “solutions” as potential salves to these issues. But these solutions do not always address the right problems. In fact, a proliferation of these solutions has added complexity, confusion, and cost, returning us to the beginning of the circle.

The crux of the issue is that there is often a disconnect between the priorities of a clinical site and the rest of the clinical research industry. As a strategic response to these multifaceted industry challenges, some sites have therefore chosen to consolidate into research site networks.

The Role Of “Sponsor Of Choice” In Consolidation

Beyond the operational challenges facing sites today, there is another contributing factor driving consolidation. In the increasingly competitive realm of clinical research, pharmaceutical companies are vying to become the “sponsor of choice” for research sites. This concept has grown in importance, with 65% of pharma companies viewing it as a top priority, up from just 14% in 2019³.

To become a sponsor of choice, pharma companies focus on building stronger, more transparent, and enduring relationships with sites. Their criteria for site selection typically include factors such as effective communication, an understanding of the future pipeline, and potential for shared investment in site capabilities and staff support and development.

In pursuit of tighter alliances with partner sites, pharma companies are forming dedicated groups to increase the connection between sites and the sponsors’ portfolios, thereby improving the overall efficiency and success of the research. The consolidation of research sites may be welcomed by pharma companies that cannot maintain close relations with all their many sites — especially in high-volume regions such as the United States. Working with site networks allows such companies to nurture relations with a smaller group of consolidated sites, creating greater capacity to deliver across the portfolio.

The Benefits Of Consolidation

Site consolidation allows sponsors and CROs to streamline operations and improve efficiency, while clinical sites gain access to broader resources and infrastructure that enhance their capabilities. Sites can benefit from consolidation by gaining scale, addressing turnover, supporting greater innovation, and providing better care to a more diverse population. Here’s how:

Gaining scale: Sites that gain scale have an easier time managing the demands placed upon them and streamlining operations. Rather than having one person trying to cover many jobs at a single site, consolidation allows for a dedicated group to divide and conquer those tasks across a group of sites. Central teams also offer sponsors a single point of contact to manage a study pipeline, and build a relationship to overcome inevitable difficulties. Networks that are fully integrated may also allow for standardization of processes, technologies, and best practices across the network, meaningfully improving efficiencies and experience for CRO, pharma companies and patients.

Addressing turnover: Staff turnover at clinical trial sites is a critical issue, with some sites experiencing turnover rates as high as 35% to 61%⁴. This disrupts trial continuity and imposes additional training and recruitment costs.

The formation of networks can mitigate these challenges by providing more professional development opportunities — adding steps to the career ladder, which might encourage an exceptional team member to see fresh challenges within sites, rather than leaving for a CRO or a pharma company. With more infrastructure, site networks may also be able to make greater investments in culture and belonging that encourage staff to stay.

Fueling innovation: Technology solutions promoted by the industry are not always what sites need or want. There are certainly opportunities for improvement, however, digital platforms that sites select for themselves — such as eSource and clinical trial management systems (CTMS), among others — can improve both quality and efficiency at sites. Allowing site choice in this regard may lead to the outcomes everyone desires — more efficient sites and more capacity to support innovative trial designs — with more empowerment to the locus of delivery:  the trial site.

As medical research becomes increasingly complex, networks can offer the flexibility and resources necessary to improve the quality and relevance of clinical research.

Patient access and care: Patients may benefit from site consolidation through improved access to trials and the potential for more personalized care. While advances in DCTs offer some valuable tools, they cannot fully replace the personal interaction and trust established in site-based trials.

In fact, site networks not only enable but also enhance those in-person benefits. Patient-facing staff, especially coordinators and physicians, can be supported by a central team when part of a site network. This allows staff to concentrate more time and attention on patients while spending less time on administrative tasks that have now been relegated to a dedicated team.

Scale of networks also allow for investments to extend their reach across diverse geographies and patient populations. Site networks should —  and some do —  invest in community relations activities to help educate and engage local patient and provider communities through general education/awareness activities, community events, partnerships with local groups and more. Regulatory agencies have signaled the importance of increased participant diversity within clinical research⁵. Networks may have an advantageous ability to extend reach, moving deeper within local communities and across geographies, improving overall access across patient populations.

The Future Of Clinical Research

Sites are under immense pressure to evolve, and the consolidation of independent sites into networks represents a potential solution. But the trend also presents potential challenges, including market monopolization as sites consolidate under fewer umbrellas. There are also concerns about focus shifting from patients to profits as they try to optimize operations across their various locations. If done poorly, consolidation could limit flexibility and site autonomy through overly restrictive workflows and processes that do not meet the unique needs of certain sites or patient populations.

Therefore, the industry needs to proceed thoughtfully to balance the benefits with the potential challenges. Doing so will improve outcomes for everyone and set a foundation for a more dynamic and patient-centered future. If done well, the consolidation of site networks will prepare us for the demands of tomorrow’s clinical research.

References:

About The Author:

Mark Scullion is the CEO of Atlas Clinical, a therapeutically-driven clinical research site network built on centralized process excellence and integrated technology. Mark has spent more than 15 years in the clinical research industry and brings a unique understanding of the site selection process and value needs of pharmaceutical sponsors. Prior to taking the helm at Atlas Clinical, he served as the global head of trial monitoring for Novartis AG, where he led a group of clinical professionals delivering over 300 clinical studies in partnership with 14,000 investigative sites across the world.