Examples and applications from Eli Lilly

Employing new tools to create patient-centered protocol designs is essential to improving patient experiences and trial efficiency. This article highlights the use of novel tools presented by Eli Lilly at SCOPE 2023 (by Hugh Dye, Associate Director, Clinical Trial Design Capabilities, and Jed Dennis, Senior Director, Clinical Trial Design Capabilities at Lilly) to prioritize patient perspectives in clinical trial design. with examples illustrating their potential value in increasing patient burden, engagement and satisfaction.

New tools to assess patient burden

One of the key challenges in designing clinical trials is minimizing patient burden. To address this issue, Lilly has developed analytical protocol design tools that quantify the impact of study design on patients, allowing protocol designers to make data-driven decisions and improve trial protocols.

Interactive visual programs

Lilly built an interactive visualization program that allowed protocol designers to view the patient journey throughout the study, with data points representing changes in patient load at each visit. Protocol designers can assess contributing factors and adjust to reduce patient burden by clicking on these data points.

This tool encourages user interaction and facilitates comparison of the proposed test design with historical benchmarks. As a result, designers can quickly identify areas for improvement and implement changes to improve the patient experience, reduce patient burden, and improve trial efficiency.

Backed by benchmarks and data-driven insights

Lilly supported its analytical protocol design tools by documenting empirical data to improve patient-centered trial design and facilitate data-driven insights. For example, researchers can compare their experimental design to previous studies by extracting and ranking the same indicators and standards from public and internal study documents.

This process allows protocol designers to identify trends in patient burden and explore the potential impact of their design choices on practical study parameters, such as recruitment and dropout rates. Consequently, researchers can make more informed decisions that benefit patients and improve study outcomes with this information.

Impact of Lilly protocol design tools on DCTs and patient burden
Decentralized clinical trials have the potential to significantly reduce patient burden by allowing patients to participate from home or work. New tools for assessing the impact of DCTs on patient burden will help researchers understand how this approach can improve patient experience and retention.

Using these tools, protocol designers can assess the benefits of decentralization beyond travel reduction, such as the impact on different patient groups and the overall patient experience. This information further reduces patient burden by refining trial protocols.
Important considerations

In my opinion, while the use of new tools in clinical trial design offers many advantages, it is important to think carefully about such approaches before jumping in head first. On the one hand, these tools can greatly improve patient experience and trial efficiency by reducing patient burden, promoting user interaction, and enabling data-driven decision making. They have the potential to change the way clinical trials are designed and executed, ultimately leading to better patient outcomes and streamlined processes. However, on the other hand, it is important to recognize that widespread use of these tools may pose challenges, such as possible biases in benchmarking and the need for continuous improvement to ensure their validity and effectiveness.

Lilly touched on qualitative aspects (ie, patient involvement in trial design), as they often collect patient insights and collect qualitative data during protocol design. However, it is important not to rely solely on numerical methods to design protocols. First, the FDA recommends that the patient’s perspective be included in trial design, and second, patient needs are constantly changing, and objective and standardized data may not be good predictors of changing patient-requested quality study characteristics. I believe that combining quantitative methods and validating the results qualitatively from a patient perspective will serve the best interests of patients, researchers, and regulators.

Summary

Adopting new tools for designing patient-centered clinical trials is essential to improve patient experiences and improve trial efficiency. Using modern technologies that focus on patient perspectives and burdens, researchers can create customized trial designs that best serve the needs of their participants. These tools increase patient satisfaction and improve the success of clinical trials.

Mo AlsumidaiMBA, MSF, is a thought leader and expert in applying business analytics to clinical trials and a regular contributor to Applied Clinical Trials.