The Pulse on Progress
TransCelerate aspires for a future state where research and development is faster, more efficient, and harnesses all the available information. We envision this happening in 3 ways:
- Full participation across all stakeholders — clinical trial sponsors, sites, investigators, patients and their healthcare providers
- Information is fully used to improve the overall quality, design and development process. We protect patients through shared, proactive safety science
- Improving the execution of research and development through greater harmonization with the potential to conduct collaborative trials
- The Common Protocol Template Initiative announced Release 6.0, which included the Common Statistical Analysis Plan (SAP) and Common Clinical Study Report (CSR) Basic Word Edition templates
- Patient Technology Accelerating Adoption of Patient-Facing Technologies in Clinical Trials Paper
Information Sharing & Harmonization
- The Common Protocol Template (CPT) Initiative announced Release 6.0 of the CPT. This latest release includes two new Therapeutic Area Libraries for Vaccines and CV-Safety, and alignment with the EU Clinical Trial Regulation analysis, ICH E6 [R2] and E9 [R1]. It also features updates based on feedback from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), more robust statistical content, improved authoring functionality and access to contraceptive related language from libraries. Additionally, the sixth release includes the Common Statistical Analysis Plan (SAP) and Common Clinical Study Report (CSR) Basic Word Edition templates. All refreshed supporting tools and resources are available on the CPT Assets page.
Improve the Patient & Site Experience
- The Patient Technology Initiative recently published a paper in Therapeutic Innovation and Regulatory Science (TIRS), titled, “Accelerating Adoption of Patient-Facing Technologies in Clinical Trials.” In this piece, the initiative team discusses the potential value of patient-facing technologies as a clinical research tool, along with the opportunities, challenges and facilitators associated with their implementation. The article also highlights several proposals for establishing a more holistic, collaborative and strategic approach for the widespread adoption of patient technology in clinical trials.
- The Shared Investigator Platform (SIP) is experiencing exciting growth – over 15,000 site users have now registered on the platform. The registered users represent 78 countries across more than 5,400 facilities, and there are more than 150 active studies in the SIP, today.
Enhance Sponsor Efficiencies & Drug Safety
- Following the successful meeting at EMA in September, there is work underway to bring the issues around Value of Safety Information Data Sources (VSIDS) to the International Council on Harmonization (ICH). TransCelerate was asked to provide input into a PhRMA & EFPIA joint proposal, which was submitted to ICH in December 2018.
Pulse on Progress - Edition Q3 2018
Pulse on Progress - Edition Q2 2018
Pulse on Progress - Edition Q1 2018
Pulse on Progress - Edition Q4 2017
Pulse on Progress - Edition Q3 2017
Pulse on Progress - Edition Q2 2017
Pulse on Progress - Edition Q1 2017