In today’s clinical trial industry, ensuring both scientific rigor and operational feasibility are critical to driving successful clinical trials. While scientific and operational teams work in parallel, bringing them together early during the trial planning phase can make a significant difference. The impact of aligning strategies can lead to a reduction of costly protocol amendments and enhanced patient and site engagement. Here’s a closer look at how these teams can bridge the gap to ensure an integrated and optimized trial plan.

Defining Scientific vs. Operational: What Are the Differences and How Do You Balance?

The scientific aspect focuses on the biological, physiological, and pharmacological elements of the study, driven by clinical development and medical teams. It also addresses patient safety, regulatory requirements necessary for product approval, as well as the statistical aspects regarding sample size and analyses to be conducted. Meanwhile, the operational elements include the specifications by which the study will operate, such as countries and numbers of sites, site and patient engagement approaches, and achieving the agreed upon timelines and milestones.

While both considerations are essential, balancing them can be a challenge. For example, a protocol might prioritize extensive data collection, but if that creates a heavy burden for patients or sites, it can negatively impact enrollment and study timelines. This is where the importance of collaboration comes into play, as both teams need to align priorities to create a feasible and efficient study plan underpinned by scientific and operational integrity and efficiency.

The Importance of Early Collaboration

As referenced above, a significant factor in optimizing clinical trials is the value created by the early collaboration between scientific and operational teams. At times, trials are planned with scientific objectives in mind but without consideration of the operational realities. This disconnect can lead to inefficiencies, with teams going back and forth to resolve issues post-protocol development or after trial initiation.

The solution? Engage all stakeholders—including medical, commercial, regulatory, statistical, and operational teams—at the very beginning of the trial planning process. By doing so, sponsors can create protocols that balance scientific needs with the practicalities of conducting the trial. This proactive approach can minimize protocol amendments, saving both time and money, while maintaining momentum at trial sites.

Key Takeaway: Involving all functional teams early in trial planning ensures that both scientific integrity and operational feasibility are addressed from the outset, preventing future delays.

Leveraging Real-World Data to Enhance Feasibility and Create Patient-Centric Protocols

Real-world data (RWD) is an important component for assessing trial feasibility and creating patient-centered protocols. For instance, access to real-world data can help make visible criteria that may be unnecessarily restrictive and can help ensure alignment with country-specific standards of care.

Business intelligence tools may also support streamlining study objectives and endpoints. An assessment is often beneficial to determine if existing data can be leveraged to answer specific questions of interest that may not be related to safety and/or exist to fulfil a regulatory requirement. By using data-driven insights early, teams can consider feasible alternatives that may streamline trial execution.

Key Takeaway: Leveraging real-world data, business intelligence tools, and site and patient voice early in protocol development results in more feasible and streamlined trial planning outcomes.

Differences Between Stakeholders and Operational Realities

Differences in scientific strategy and operational feasibility can be common in clinical trials, making early and open discussions essential. While it can be tempting to develop a protocol and study timeline with the perfect patient and site in mind; not accounting for the operational realities and larger population can lead to less than desirable outcomes.

To balance these needs, teams can implement strategies to account for the realties upfront; some of these areas of focus may include:

• Inclusion/exclusion impact assessments
• Conducting site and patient focus groups
• Development of patient journey maps to then develop customized engagement strategies
• Early and strategic feasibility, developing country, start-up, and enrollment timelines based on the current landscape and guidelines
• Proactively planning and investing in necessary patient and site engagement support versus taking a “wait and see” approach
• Potential to decentralize components of the trial

Implementation of these strategies may vary from trial to trial and often have other use cases in which they can be applied. A recent example in a rare disease trial discovered through patient focus groups that their most bothersome disease symptom was different from what the key opinion leader advisory board indicated. This insight allowed the planning team to adjust their approach which included updates to the patient engagement messaging and quality of life measurement.

Key Takeaway: Open communication between all stakeholders helps balance rigor with feasibility, leading to more realistic and successful study outcomes.

Planning for Success

The takeaway is clear: involve all functions and applicable partners early in the trial planning process as it will prevent costly delays and protocol amendments. While the pressures to achieve the first patient enrolled is often an influencing factor, the same level of importance needs to be accounted for to recruit the last patient in a trial. Bringing patients hope is the collective goal and it is critical to plan on their behalf. Failing to plan is planning to fail—invest in comprehensive, cross-functional planning early to set your trial up for success.

For more questions about Advanced Clinical’s feasibility and study optimization solutions, visit our website.

The Authors

Donna Hanson, VP, Strategy & Optimization

Sally-Ann McDowell, Senior Clinical Development Strategy Director