Historical Trial Data Sharing

The Historical Trial Data Sharing Initiative, formerly known as Placebo and Standard of Care, was established to enable the sharing of data to maximize the value of clinical data collected historically in the placebo and standard of care control arms of clinical trials.

Rationale

The Historical Trial Data Sharing (HTD) Initiative was established to enable the sharing of de-identified data to maximize the value of clinical data collected historically in the control arms of clinical trials. For purposes of the HTD sharing solution, placebo data is defined as any data generated from a control arm of a trial where the study participants received only an inert substance. Standard of care data is defined as any data generated from a control arm of a trial where the study participants received a marketed, active treatment.

The HTD Initiative has created a platform that enables TransCelerate Member Companies to share controls data. Ultimately, this solution aims to advance clinical research through improved clinical trial design, faster clinical trial execution, a better understanding of disease, and improved study participant experience.

Please note, this initiative was formerly known as Placebo and Standard of Care (PSoC). You may see references to PSoC throughout our website as we continue to update our content.

Benefits

Benefits for Investigators

  • Reduced study participant recruitment burden
  • Reduced burden of drug inventory tracking and logistics management, enabled by potential re-use of historical standard of care data

Benefits for Patients

  • Speeding delivery of therapies to patients
  • Improved study design, leading to less patients needed for clinical trials
  • Better management of study participant safety during trial execution due to rapid understanding of safety signals

Benefits for Sponsors

  • Improved study design
  • Reduction in protocol amendments
  • Better understanding of disease models to identify the right targets

Available Solutions

To learn more about Historical Trial Data Sharing (Controls) and to access our white paper discussing the potential benefits of the initiative and uses for the data, “Development and Implementation of a Pharma-Collaborative Large Historical Control Database”, visit our Initiative Solutions page.

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