Optimizing Data Collection

The Optimizing Data Collection initiative seeks to activate sponsors to engage in data optimization initiatives through a data-driven value case approach and provide resources to support the internal assessment of data collection practices. This initiative aims to reduce the burden on patients, sites, and sponsors by enabling more efficient data collection. Workstream solutions are coming in 2025.

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 significant 40.6% increase in total procedures and a 283.2% increase in data points collected during Phase III pivotal trials over the past decade.¹

TransCelerate is well-positioned to advance solutions that address protocol complexity and thereby reduce burden across patients, sites, and sponsors.

The desired outcome 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.

Benefits

Enables a mindset shift across sponsors to act on and support initiatives that optimize data collection while reducing patient and site burden.
Provides considerations for sponsors to support data collection efficiencies and effectiveness.
Improves understanding of the impact and implications of data collection decisions across the ecosystem, leading to more intentional, streamlined, and patient-centric data collection approaches.