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In Development

Optimizing Data Collection

The Optimizing Data Collection (ODC) initiative aims to help sponsors design clinical trial protocols with more focused and considered data collection. By providing structured approaches to evaluate protocol procedures, data points, and collection frequencies, ODC aims to support more intentional protocol design decisions while reducing unnecessary burden on patients, sites, regulators and other stakeholders and upholding scientific, operational and regulatory standards. 

Overview Solutions and Resources Media and Webinars

Optimizing Data Collection

Overview

ODC enables sponsors to develop structured and repeatable approaches to critically examine protocol design before complexity becomes embedded in studies. The initiative is grounded in a collaborative study with the Tufts Center for the Study of Drug Development (CSDD), which examined 105 multi-therapeutic protocols from 14 TransCelerate member companies to quantify how core, non-core and standard or required procedures contribute to clinical study reporting and stakeholder burden. 

Solutions and Resources

Explore a suite of solutions designed to help sponsors and other interested stakeholders optimize clinical trial data collection from early development through study closeout. These resources support teams in evaluating data needs, reducing unnecessary complexity and aligning collection practices with scientific objectives while reducing patient and site burden.

Analysis

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.
0.35 MB
Publication

Insights Informing Strategies for Optimizing the Collection of Clinical Trial Data

This peer-reviewed publication, available in Therapeutic Innovation & Regulatory Science (DIA TIRS), outlines strategic approaches to improving data collection in clinical trials.
Framework

Clinical Development Plan (CDP) Framework & Considerations for Data Optimization

A structured framework that can be used to align study objectives and endpoints to the CDP, which is integral to the Target Product Profile (TPP), helping teams define the evidence needed for a given indication and avoid unnecessary complexity across protocols.​
1.03 MB
Guide

Protocol Considerations for Data Optimization​

A structured, question‑based resource that helps guide teams through endpoint‑guided decision‑making to map procedures, frequencies, and data needs, enabling more fit-for-purpose protocol design and data collection.
1.12 MB
Guide

Participant & Site Burden Resource Landscape for Protocol Optimization

A consolidated view of existing ecosystem resources that may help sponsors and other stakeholders understand and assess participant and site burden in relation to study procedures and data collection, while enhancing awareness of available tools related to protocol design.
0.44 MB

Media and Webinars

Nearly a third of clinical trial procedures may not drive results

Article
Less Can Be More When It Comes to Collecting Data in Studies 

Article
Sponsors Collect Too Much "Non-Essential" Data, Say Tufts And TransCelerate 

Article

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