Closing the Gap Between Study Design and Execution: The Need for Better Sponsor-Site Collaboration

Slope recently presented at #FOB2023 on the topic of value-based study planning as a way to improve site and sponsor experiences. The presentation sparked an energized conversation around the high value we place on study start-up, while other important focus areas that directly impact a trial’s success further downstream remain overlooked.

This week's blog explores how siloed processes can create a gap between study design and execution in clinical trials. This gap presents an opportunity to unlock untapped value that can directly impact trial outcomes.

The problem: The gap between study design and execution

“Theory and practice sometimes clash. And when that happens, theory loses. Every single time.”
_{— Linus Torvalds}

No matter how sound a theoretical concept may be, it may fail in the face of practical challenges. This is especially true in the clinical trial process where siloed organizations contribute to the end-to-end drug development lifecycle. 

It is considered best practice for sponsors to engage with therapeutic area KOLs to advise on study design and drug development. These KOLs contribute to the science, the study drug category, and patient population, however, there is so much more to a successful clinical trial — including how you operationalize that trial. Less commonly, sites are asked to contribute to study operations and study execution, taking on aspects such as feasibility, overall assessments, operational flow of a program, change management, and supply chain issues. 

Currently, there is a significant gap between clinical trial design and clinical trial execution: Sponsors and CROs are responsible for the study design and protocol, however they are often developed without site input, despite the fact that sites are responsible for patient enrollment and retention. Consequently, sites are left to execute the trial to the best of their ability within the confines of the study's parameters. These siloed processes and disjointed communications can become quite costly, requiring amendments before the trial even gets underway.

According to Tufts Center for the Study of Drug Development (Tufts CSDD), 45% of amendments are deemed avoidable, and can cost upwards of $500,000 to implement. The primary reason for amending protocols is to relax eligibility criteria, which contributes to the 50% of sites that under-enroll — or entirely fail to enroll — patients in their trials. Furthermore, 40% of all protocol amendments are implemented before the first patient receives a dose, suggesting that the feasibility of the protocol was not adequately evaluated prior to launching the study.

Given those staggering statistics, why has there been so little progress in fixing these issues? Could the problem be as simple as not involving the site earlier in the process and pressure-testing study designs before enrollment begins?

As an industry, we need to start examining every part of the clinical trial lifecycle to uncover areas that have been largely ignored or pushed onto vendors to manage. 

The opportunity: Sponsor-site collaboration 

Not many sponsors see sites as partners, or leverage their knowledge of best practices. For those that do, it is easy to see how better sponsor-site collaboration can deliver a strong ROI through cost reduction, start-up timing, and enrollment, while also seeing value in intangible areas such as site and patient satisfaction.

To identify opportunities for increasing value, a structured approach called value-based planning can be used. This involves allocating resources to areas of highest value. It's important to note that this process should not be a one-time survey, but rather an ongoing, in-person or virtual activity. Sponsors should aim to build collaborative relationships with multiple sites in each key therapeutic area to ensure the consideration and integration of different perspectives. These long-term relationships should allow for interaction throughout planning, execution, and reflection upon study completion. Both sponsors and sites need to actively participate in this approach.

Here are three steps to get you started:

1. Identify and consolidate all study processes and activities that involves your organization and sites ‍

Pre-identify the processes across all aspects of a clinical trial, and develop an end-to-end workflow for site input. Ensure that this includes any study activity that will benefit from sites’ input across the duration of a program. 

Stay flexible and ask sites to add any additional activities and details that you may not have considered, so that you can look at the entire process from both perspectives.

2. Analyze each activity and process based on its value

Ask sites what their ideal processes would entail, and gather insights into both what works well and what doesn’t. Start sharing your experiences and focus on outcomes.  

3. Together, determine best practices and brainstorm solutions 

Create a value-based improvement grid that measures the ease of completion and the value of each study process and activity in relation to all parties involved.

Start with quick, easy, and cheap wins to show the sites that you are serious about creating joint value. 

The key is to close the gap between theory and practice, and bring sponsors and sites together as collaborators and partners in the clinical trial process.