Modernizing Clinical Trials: A Site-Centered Roadmap for the Future

This presentation was created based on the following Applied Clinical Trials articles:

• From Isolation to Integration: Improving Site-Sponsor Collaboration in Clinical Trial Startup
• Why Clinical Trials Are at a Crossroads and How Site Networks Are the Key to Success
• Beyond Prediction: An Evidence-Based Framework for Assessing Site Selection Decisions

Let's be honest, clinical trial operations are at a critical turning point. For way too long, the entire industry has been stuck, bogged down by the same old problems that slow down lifesaving treatments and make everything more expensive. So today, we're going to walk through a new roadmap, a way to actually modernize how these trials get done based on what leaders in the field are saying needs to change.

Let's just start with a number that should make everyone pause: 80%. That's how many clinical trials fail to hit their initial enrollment targets on time. Think about that. This isn't some small logistical hiccup. It's a colossal bottleneck that stalls progress and keeps new medicines away from the people who desperately need them. The problem doesn't just stop at getting patients through the door, even when a trial manages to enroll enough people, keeping them is a whole other battle. On average, a staggering 30% of patients drop out before a study is even finished. Can you imagine what that does to the data? When nearly a third of your participants just disappear, it can seriously threaten the integrity of the entire trial. With this next statistic, this one might be the most unbelievable of all: 50%. That's how many clinical trial sites end up enrolling just one patient, or, even worse, zero patients. Just let that sink in. Half the sites we activate, fund, and train end up producing absolutely nothing. The waste of time, of money, of human effort is just immense.

With a system this broken, where on earth do we even start to fix it? Well, you start at the beginning. You have to fix the foundation, and in this world, that means reimagining the entire study startup process, because it doesn't matter how amazing the science is, if a trial stumbles out of the gate with a slow, disconnected start, it's already fighting an uphill battle, and right now, the way we kick things off is pretty much stuck in the past. The real problem is that all the key players—we're talking the sites, the sponsors, the CROs—they're all operating in their own little bubbles. It's like they're on isolated islands, as it says here. This forces the research sites to juggle a dizzying number of different sponsor-specific systems, creating a mountain of redundant work that pulls them away from what actually matters: taking care of patients.

This breaks it down into the three biggest headaches. First, you've got feasibility, which has become this dreaded nightmare of filling out the same information over and over again on slightly different forms. Then you've got site visits, which often feel like a sunk cost, pulling key staff away from their actual jobs. Finally, contracts and budgets, a black box of endless back and forth that can easily add weeks, if not months, to the startup time. This quote from Nick Spittal just cuts right through all that noise, he says feasibility really just boils down to two simple questions: do I have access to the right patients, and how many can I actually enroll? That's it. But somehow, we've buried these two fundamental questions under mountains of paperwork and complexity that honestly don't add much value.

What does a better future look like? Well, this slide gives us a great before and after picture. We need to go from duplicative questionnaires to centralized requests. We need to swap out all these overlapping site visits for standardized, periodic check ins, and we have to replace those painful, lengthy negotiations with pre-negotiated master agreements. The glue that holds it all together? Integrated technology platforms that let everyone talk to each other.

Let's say we do all that, we create this beautifully streamlined startup process. That's a huge win, but it's only one piece of the puzzle. What good is a perfect process if the research sites themselves are stretched to the breaking point, and that brings us to the next massive challenge we need to solve. This is the second pillar of our solution, empowering the sites. These are the folks on the front lines. They are the operational backbone of every single clinical trial. They are absolutely critical to success, and frankly, they are struggling and need our support. The pressure they're under is just immense. Look at this list. We're talking staffing shortages and massive burnout, hurdles with implementing new tech, arguments over pricing, and contracts that are totally inflexible. On top of all that, there's a huge administrative burden. It's a perfect storm that makes it incredibly difficult for them to do their best work, and that's where site networks enter the picture.

A site network is basically an organization built to tackle these exact problems. They provide the infrastructure, the day-to-day operational support, and even flexible models like community clinics or in home visits. This allows individual sites, especially smaller ones, to not just participate, but to actually succeed. The value they bring is pretty clear, as you can see here, networks help expand patient access by reaching deeper into communities, that in turn, directly boosts both recruitment and retention rates, and maybe just as important, they take a huge amount of the operational burden off the site staff, which frees them up to focus on patient care and getting high quality data.

Now, there is this common misconception out there, a fear that if a site joins a network, it is going to lose its independence, but the reality is exactly the opposite. A good network isn't about control, it's about collaboration. It strengthens the site's capabilities while making sure it holds onto its local expertise, and most importantly, the trust it's built with its patients.

Great, we've streamlined the startup and now we're empowering our sites. That's huge progress, but it leads to the next logical question, how do we get smarter about picking the right sites for the right trials in the first place? This leads us right into our third and final pillar. We have to evolve beyond how we've always done site selection. It is time to stop just predicting which sites might do well, because clearly that's not working, and start actually understanding the real reasons behind high performance. The fundamental flaw in how we do things now is right here. We're all about prediction over explanation. We rely on these complex predictive models and get this, feasibility surveys filled out by the sites themselves. It creates this totally circular reasoning where we're asking the sites to solve the very prediction problem we have. It might tell us what could happen, but it never, ever tells us why.

A new evidence-based framework suggests we look at sites in three different layers. First you have the inputs, these are the tangible things, the staff, the facilities, the patient population. Then you have the outputs, which are the results we can all see, like enrollment numbers and data quality, but the real magic, the real breakthrough, is understanding what connects the two, and that brings us to that crucial middle layer, dynamic capabilities. You can think of this as the invisible engine that truly drives performance. It's not about what resources a site has, it's about how well it uses them. It's about their ability to coordinate, to adapt, to solve problems when things inevitably go wrong. This is the secret sauce that separates a good site from a great one.

This case study is the perfect example: A CRO is facing some serious enrollment delays. Now, the old playbook says just add more sites, more inputs, but they didn't do that. Instead, they focused on boosting the capabilities of the sites they already had. They engaged more, they clarified the protocol, and guess what, enrollment took off. It's such a powerful lesson.

When you take these three big ideas, fixing startup, empowering sites, and evolving how we select them, and you put them all together, what you get is a single, unified roadmap for the future of clinical trials, and here it is boiled down into three clear actions. Number one, we have to simplify and standardize the startup process, to cut out all that redundant work. Number two, we have to actively support and empower our sites using collaborative networks. Number three, we need to turn site selection from a guessing game into a true learning system that helps us understand performance.

For anyone working in clinical operations, the message here is crystal clear. This isn't about one simple fix. It's about a fundamental shift in our thinking. It's a commitment to truly embracing collaboration, to empowering our sites and to adopting frameworks that make our work smarter, more efficient, and more equitable for the patients waiting at the end of the line.

I'll leave you with this one final thought. If every single stakeholder, every sponsor, every CRO, and every site decided to focus on improving just one of these core capabilities, whether it's coordination or problem solving, where do you think we would see the biggest impact first?