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Optimizing Data Collection

The Optimizing Data Collection initiative builds on the evolution of ICH guidance and seeks to activate sponsors to highlight areas to consider in protocol design to optimize procedures and their frequencies. The initiative is building a framework of solutions with an aim to reduce unnecessary burden on patients, sites, regulators, and other stakeholders by helping sponsors critically assess what data is collected and why, while balancing scientific, operational, and regulatory demands.

Key resources

Rationale

Research conducted by the Tufts Center for the Study of Drug Development (CSDD) highlights the escalating burden imposed by protocol design on patients and sites. Yet, the complexity of protocols has surged across the industry, with a 40% increase in total procedures and a 283% increase in data points collected during Phase III pivotal trials over the past decade.1

The Optimizing Data Collection initiative expands this research through a collaborative study between Tufts CSDD and TransCelerate BioPharma. In this recent study, 105 multi-therapeutic protocols across 14 TransCelerate Biopharma companies were collected, and the analysis was conducted by Tufts CSDD. The study quantified the collection and use of core, non-core and standard or required procedures and data points within a study and examined their relationship to clinical study reporting and stakeholder burden (i.e., patients and site burden).

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.

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 Workshop 2024: Washington, DC, United States.

Solutions

Publication: Discover our latest research, “Insights Informing Strategies for Optimizing the Collection of Clinical Trial Data.” This manuscript, submitted to Therapeutic Innovation & Regulatory Science (DIA TIRS), outlines strategic approaches to improving data collection in clinical trials. 

Regulatory Landscape Assessment: Our analysis of key ICH guidelines – such as E6(R3), E8(R1), E19, and M11 – shows how they apply to the Optimizing Data Collection initiative and why they matter. 

Additional solutions and resources coming soon. 

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.

*These are potential benefits