Optimizing Data Collection

Building on this evidence, the Optimizing Data Collection initiative conducted a collaborative study between Tufts CSDD and 14 TransCelerate BioPharma member companies. The analysis of 105 multi-therapeutic protocols quantified how core, non-core and standard or required procedures contribute to clinical study reporting and stakeholder burden (i.e., patients and site burden). Findings revealed that nearly one-third of the procedures and data collected in Phase II and III protocols are non-core or non-essential.

These insights underscore a clear opportunity: sponsors need structured, repeatable approaches that help teams think critically about what data is collected, why it is needed, and how often it must be captured. By reducing unnecessary assessments and streamlining evidence generation, organizations can meaningfully lower burden while preserving scientific and regulatory rigor.

TransCelerate is well-positioned to advance solutions and thereby reduce burden across patients, sites, and sponsors. The goal is to motivate sponsors to take action to support initiatives that optimize data collection via simplified protocol design.

Benefits:

• Provides considerations for sponsors to support study-level evaluation of fit-for-purpose procedural needs and downstream data collection efficiencies and effectiveness to reduce participant and site burden.
• Improves understanding of the impact and implications of procedure and data collection decisions across the ecosystem, leading to more intentional, streamlined, and participant-centric clinical designs.

1. Getz, K., Sharma, M., Ibrahim, S., Baykal-Caglar, E., Sam, L., Comic-Savic, S., (2024, January 31). Optimizing Study Design and Setting the Stage for Efficient Conduct through Quality by Design, [Paper presentation]. Duke-Margolis Institute for Health Policy Public Workshop2024: Washington, DC, United States.