The Placebo and Standard of Care (PSoC) Initiative 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. For purposes of the PSoC sharing solution, placebo data is defined as any data generated from a control arm of a trial whereas the subject received only an inert substance. Standard of care data is defined as any data generated from a control arm of a trial whereas the subject received a marketed, active treatment. Our desired outcome is to establish a platform that enables TransCelerate Member Companies to enhance clinical trial designs, develop disease models, provide context for safety observations and improve their ability to recruit patients.
The PSoC solution will have the potential to significantly reduce the number of patients enrolled in clinical trials as it allows the reuse of data from previous studies. In addition to supporting reduced patient exposure in medical research, which is particularly important for rare diseases, it will decrease the time spent on cumulative trial execution speeding therapies to patients while saving millions of dollars for each company. It will also enable the improved interpretation of potential safety signals observed during clinical trials and allow for more accurate study design and power calculations through enhanced model based approaches.
TransCelerate has devised several Use Cases for which application of the PSoC sharing solution could potentially be implemented to generate the benefits previously noted. These Use Cases include:
- Enhanced safety signal interpretation
- Reduced size of the control arm (Early Phase Trials)
- Reduced size of the control arm (Late Phase Trials)
- Precision powering by minimizing missing data
- Inclusion / exclusion criteria optimization
- Model-based, enhanced, trial design
- Clinical feasibility optimization by understanding geographic influences
- Biomarker development
For further information on our Use Cases see our Initiative Assets below.
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.