The Placebo and Standard of Care (PSoC) Initiative was established to enable the sharing of de-identified data to maximize the value of clinical data collected historically in the placebo and standard of care control arms of clinical trials. For purposes of the PSoC 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 PSoC Initiative has created a platform that enables TransCelerate Member Companies to share placebo and SoC 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.
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
To learn more about Placebo and Standard of Care Data Sharing 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 Assets page.
Common Protocol Template
The Common Protocol Template Initiative is working with industry stakeholders and regulators to create a model clinical trial protocol template containing a common structure and model language to improve accuracy in data recordation and speed study start up.
Clinical Data Standards
The Clinical Data Standards Initiative, in collaboration with leading industry organizations, aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and meta-data, while improving patient safety and outcomes.