Why involve Tech, Device, and Data Companies now?

Stakeholders can collaborate closely with technology, device, and data companies to create more adaptive, data-driven, and patient-centric protocols while they are in draft stage. This not only improves the trial's feasibility but also accelerates its overall success, reducing the risk for future protocol amendments.

What aspects of the draft protocol should they inform?

• Patient Population Identification: Having access to large EHR data networks allows Sponsors to identify and characterize patient populations. Using real-world data, Sponsors can use these findings to simulate a clinical trial's patient pool before the trial begins.
• Diversity Action Planning: Leverage technology to assess the epidemiology of indications and define the diversity benchmarks for target populations. With these insights, sponsors can establish clear, measurable targets, ensuring that their trials are as diverse as the patient populations they aim to help.
• Optimize Inclusion and Exclusion Criteria: Data and technology allow sponsors to assess the impact of their clinical trial protocol inclusion and exclusion criteria on patient cohorts. As they draft their protocol, they’ll be able to see how each criterion affects the overall size and makeup of the patient population they're considering. This is a vital step in identifying any overly restrictive criteria that may unintentionally exclude certain groups—especially underrepresented or hard-to-reach populations.
• Predictive Modeling and Analytics: Sponsors can use predictive modeling to estimate trial outcomes and refine protocol parameters, such as optimal sample sizes, dosing schedules, and tailored patient populations based on age, disease state, and other protocol specified criteria.
• Retrospective Data Analysis: Researchers can examine data from past clinical trials or real-world outcomes to understand how the protocol design might impact the trial's success. For example, by analyzing patient adherence or safety data from similar trials or healthcare settings, researchers can anticipate potential challenges, such as high dropout rates, adverse events, or unanticipated side effects.