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