Historical Trial Data Sharing

The HTD initiative aims to promote the responsible secondary re-use of Historical Trial Data, particularly from control arms, with the overarching goal of enhancing study design and efficiency in clinical development, ultimately reducing the number of patients on placebo, and accelerating drug development processes.

Rationale

The Historical Trial Data Sharing Initiative facilitates the sharing of de-identified historical trial data from control arms to optimize clinical data utility.

Through the HTD initiative, a comprehensive platform has been established, allowing TransCelerate Member Companies to share control arm data. The primary objective of this endeavor is to advance clinical research through several key facets: enhancing clinical trial design, expediting clinical trial execution, fostering a deeper comprehension of diseases, and enhancing the overall study participant experience.

Please note this initiative was formerly known as Placebo and Standard of Care (PSoC). References to PSoC may still be found throughout our website as we continue to update our content.

Benefits

Accelerates the development of lifesaving drugs, enabling faster access to patients
Enables the ability to supplement control arms, thereby allowing more patients to receive investigative therapy rather than a placebo, expediting scientific insights
Empowers participating companies to engage in innovative internal trial design and planning, influencing precision powering and sample size calculations
Improves understanding of diseases, geographic distinctions, and their impact on safety and efficacy outcomes
Enhances safety signal interpretation by facilitating the ability to compare placebo data with compound data

Related Initiatives

Clinical Content & Reuse

What is Clinical Content & Reuse (CC&R) Click on the Harmonized Model Content, Reuse Capabilities and Clinical Template Suite sections to learn more about CC&R. The Clinical Content & Reuse (CC&R) Initiative enhanced clinical trial processes by providing harmonized structure and proposed model content within clinical trial documents that can be reused throughout the project…

Clinical Data Standards

Clinical data are reported by individual trials in various ways which may cause a labor intensive process to gain data insights. The Clinical Data Standards Initiative, in collaboration with CDISC (Clinical Data Interchange Standards Consortium), C-Path (Critical Path Institute), NCI- EVS (National Cancer Institute – Enterprise Vocabulary Service) and FDA as part of the CFAST (Coalition For Accelerating Standards and Therapies), aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and metadata, while improving patient safety and clinical trial outcomes.