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 meta-data, while improving patient safety and outcomes.
The Clinical Data Standards Initiative provides a foundation or platform that will enable data aggregation, cross study analysis and end to end data flow, thus providing many benefits to stakeholders such as:
- Facilitating the combination of data from multiple disparate sources for analyses to plan new studies & enhance medical and scientific insights and knowledge, thus enhancing disease management
- Enabling operational efficiencies in data management and analysis
- Enabling more consistent data collection in clinical studies leading to more efficient studies with higher quality data which ultimately leads to improved knowledge about safety and efficacy of the compound
- Facilitating the demonstration of traceability of data
- Enabling more efficient regulatory reviews
- Providing a foundation for interoperability as stated in FDA Guidance on electronic regulatory submissions (Feb 2014)
- Enabling future integration of clinical studies with Electronic Health Record (EHR) or Electronic Medical Record (EMR)
The Therapeutic Area Data Standards are freely available at the CDISC website on the following link. An overview of the ongoing Therapeutic Area Data Standards development projects is also available. Through the SHARE (Shared Health And Research Electronic library) technology environment, we have the ability to facilitate and accelerate setting Data Standards in Therapeutic Areas. SHARE, a cornerstone of the CDISC technical roadmap, is a global electronic repository for developing, integrating and accessing CDISC metadata standards in electronic format. SHARE is expected to dramatically improve integration among CDISC foundational standards and controlled terminologies, and support greater interoperability with healthcare.
Clinical Data Transparency
The Clinical Data Transparency Initiative was formed with a mission of developing a model approach for redacting privacy information found in clinical study reports and a model approach for the anonymization of patient-level data shared with the broader healthcare community.
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.
Placebo and Standard of Care Data Sharing
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.