Why Clinical Trials Are at a Crossroads and How Site Networks Are the Key to Success

As clinical trial protocols become increasingly complex, patient recruitment and retention continue to bottleneck. This is delaying trial timelines at clinical trial sites, which are already struggling with fewer on-site resources.

At the same time, the push for diversity, decentralization and real-world generalizability of data has grown louder, urging the industry to reevaluate how and where trials are delivered.

This article will explore a road map to help trials stick to timelines, bolster patient recruitment and retention, and how reducing operational pressure and enabling clinical research in new communities around the world can be achieved through the creation of more accessible and efficient sites.

Industry-wide challenges & the impact on sites

To understand how industry-wide challenges compound the pressures that sites already face, it’s important to first get an overview of these existing challenges:

• Nearly 80% of trials fail to meet initial enrollment targets and timelines
• Despite constant discussion around diversity, still only 25% of global trial participants are people of color, raising continued questions about equity
• Between 32%-40% of a trial’s budget is dedicated to recruitment, yet:
  • 85% of clinical trials fail to retain enough patients
  • 30% is the dropout rate across all clinical trials
  • Over two-thirds of sites fail to meet original patient enrollment regardless of the trial
  • About 50% of sites enroll one or no patients in their studies

These statistics show just how difficult it is to bring new, innovative therapies to market. Furthermore, they highlight how high-risk clinical trials can be—the therapy or drug may be the answer for many living with pain and illness, yet without participation, they may never make it into the healthcare system.

The knock-on effect of these challenges is being felt most intensely at the site level. As the ones conducting the trial, it is up to them to ensure that not only do they enroll enough patients, but that protocol adherence and data quality is at the highest level. They also need to keep patients enrolled in the trial until completion. In an environment where the average dropout rate is 30%, this is no small feat.

These pressures are then very often exacerbated and compounded by the fact that many sites are under-resourced and experiencing staff shortages due to burnout. Furthermore, not only are they facing industry-wide challenges, but they have their own set of challenges and burdens to overcome.

While each site will have its own specific challenges, these are the most common problems sites say are barriers they face when conducting successful, timeous clinical trials:

• Technology implementation: Despite significant progress and clear advantages of technology, some sites still face obstacles with infrastructure, data security and quality concerns, and training staff on new technologies and systems; many sites still remain paper based
• Pricing tensions: The trial budgeting process can at times leave the site and the sponsor/contract research organization (CRO) in opposing corners, even though they are trying to achieve the same goals; this can also cause significant delays to trial timelines
• Misaligned incentives: Much like the constraints in pricing, incentives can sometime be perverse. Sites are onboarded at a reduced cost but are not empowered to succeed—which ends up costing more and affecting trial timelines. The time and financial cost of this can compound significantly
• Inflexible contracting: The instinct to repeat what has worked in the past may feel safe, but clinical research is evolving rapidly; what worked five years ago may no longer deliver the same results

After examining these difficulties, it’s clear the onus is on the wider industry to reevaluate how it engages with and supports clinical trial sites. Post-COVID-19, clinical trial sites have become an even more delicate and complex ecosystem and if we want it to develop and thrive, we must accept that the current approach is no longer sustainable.

There is often a temptation to repeat what has worked in the past, but in doing so, we risk stagnation. We work in clinical trials because we believe in advancing medicine and improving health outcomes. That same mindset must apply to how we design and operationalize our trials. If we are innovating at the molecular level, why are we still holding on to outdated operational models? It’s time the approach to trial delivery evolves in parallel—with bold thinking, modern tools and a commitment to making research more inclusive, efficient and sustainable.

How relationships with sites need to evolve

Often, we see transactional relationships between a research site and a sponsor or CRO. These are perfectly acceptable if that’s how both parties prefer to operate. However, this approach does not align with how patients want to experience healthcare when participating in a trial. The result is often a drop in enrollment and retention.

More relational relationships between site and sponsor or CRO promote deeper understanding and shared values; this can be accomplished through:

• Integrating & simplifying processes at the point of care
• Managing resources effectively by making sure your sites have the right support & training
• Streamlining data collection to reduce administrative burden
• Collaborating with your vendors, ensuring there are shared objectives & milestones
• Developing and maintaining a strong relationship with your site teams
• Keeping the focus on overall patient well-being, not just trial-related adverse events/serious adverse events

These changes may seem simple, and if approached in that way, won’t yield the desired results. Rather, these steps should be implemented with intent and with specific outcomes laid out. By understanding what is needed by all parties it becomes easier to focus resources, time, energy and money on specific key areas that are most likely to bring about the needed change.

Breaking down barriers for patients & sites

Once there is an understanding of what sites need, it then becomes possible to create and execute a strategy designed to enable them.

Site-enabled strategies can reduce recruitment delays, improve trial diversity and create an actionable patient-centric approach to clinical trials. There are long-term benefits to adopting a more human-centered approach to trials.

For patients, these benefits can include:

• Expanded access to clinical trials in more communities around the world
• Reduced burden of treatment
• Supporting comfort & well-being—improving quality of life
• Flexibility for them, their families and/or their careers

For sites, the key advantages are:

• Increased recruitment rates
• Expanded geographical reach
• Improved retention rates & compliance
• Optimized data collection

However, designing and executing strategies that then go on to produce these kinds of results can be both time-consuming and costly, especially for a “one-off” trial. This is why sponsors and CROs are turning to site networks.

Not all site networks work to achieve the same goals

Site networks serve to empower sites to deliver clinical research. Many will work to identify sites that may be appropriate to run a trial and expand the feasibility efforts to find the right sites, while others will build the resources and deliverables a site is capable of. Allowing sites to become more flexible in their trial delivery models, including in-home visits and community-based support, is key to trial success.

Site network models don’t need to be costly to deliver meaningful impact—they need to be efficient, sustainable and focused on long-term site success. There’s a persistent misconception that joining a network means losing independence or being absorbed into a large corporate structure.

In reality, many networks are designed to do the opposite: to strengthen site autonomy by providing access to infrastructure, operational support and experienced resourcing that individual sites may not otherwise be able to access. The most effective networks build long-term research capacity by helping sites grow their capabilities while staying rooted in the communities they serve. They reduce operational burden, simplify trial delivery and offer dedicated support, all without compromising a site’s unique identity.

Networks can also grow and learn from the sites they support. Community physicians, nurses and care teams often understand what works best for their patients. If we don’t listen to their insights or enable them to operate independently where possible, we risk losing valuable institutional and cultural knowledge—something that cannot be replaced.

Redesigning trials around people, not processes

The success of a clinical trial doesn’t begin with the first patient enrolled; it begins with thoughtful, inclusive trial design that empowers sites and puts patients first from the beginning.

The challenges we face today, from underperforming sites to rising dropout rates, are not inevitable. They are the result of a system still rooted in outdated models. If we truly want to accelerate drug development, improve diversity and reduce trial failure rates, we must evolve our approach. That means listening to site teams, investing in under-resourced communities and delivering the kind of flexible support that enables every participant—whether patient or professional—to succeed.

Site networks can be a powerful engine for this kind of change. When built on collaboration, not control, and focused on capability over conformity, they allow more sites to engage in research, more patients to access care and more therapies to reach the people who need them most.

In an industry built on innovation, it’s time for our trial infrastructure to catch up.

Caroline Potts, General Manager, Site & Patient Services at MRN