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Quarter Q3

Pulse on Progress

Table of Contents

Introduction

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 three ways:
  1. Full participation across all stakeholders — clinical trial sponsors, sites, investigators, patients and their healthcare providers
  2. Information is fully used to improve the overall quality, design and development process. We protect patients through shared, proactive safety science
  3. Improving the execution of research and development through greater harmonization with the potential to conduct collaborative trials

Newest Resources and Company Milestones

  • TransCelerate debuted a new look for the website. It now boasts exciting new features, such as the Our Solutions Interactive Tool, blog, an updated News Center and an Engage with Us page.
  • Dietmar Berger, Chief Medical Officer and Head of Global Development at Sanofi, has joined TransCelerate’s Board of Directors.
  • Robert Baker, Vice President, Clinical Program Design and Exploratory Medicine/Pharmacology at Eli Lilly & Company, has been appointed as the new Corporate Secretary of TransCelerate.
  • TransCelerate is a participant in the newly-launched Project Vulcan HL7® FHIR® Accelerator program and has played an active role throughout the setup process, including designing the Project Vulcan logo. For more on Project Vulcan, visit here or read this issue’s The Latest feature for in-depth details.

Pulse On Progress Updates

Improve the Patient & Site Experience
Objectives

Improve the patient and site experience by decreasing burden, enabling a better-informed patient and improving clinical research awareness, participation & engagement.


Information Sharing & Harmonization
Objectives

Enable the industry to move toward greater harmonization of process and facilitate the sharing of information amongst industry stakeholders to enable the industry to capture, optimize and experience efficiencies.

  • In July, TransCelerate participated in the webinar “Accelerating Science in the Age of COVID-19: Three Key Data Initiatives” with Vivli and the COVID Collaboration Platform (CP). The webinar examined the work that each organization is doing to support stakeholders to more quickly collaborate, share and analyze COVID-19 data to accelerate science. TransCelerate specifically discussed COVID-19 data sharing through DataCelerate®. For those that missed the webinar, you can watch a recording of the discussion or view the slides
  • The Historical Trial Data (HTD) Sharing (Controls) Initiative team announced two new publications. One paper, entitled “Assessment of Placebo Response in Objective and Subjective Outcome Measures in Rheumatoid Arthritis Clinical Trials,” found that even patients randomized to placebo in a rheumatoid arthritis trial demonstrated improved outcomes, a finding that may influence future trial design. The other, entitled “Historical Controls in Randomized Clinical Trials: Opportunities and Challenges,” includes insights into the potential for large-scale historical placebo data to be used by drug developers and patients to guide trial design and analysis. Both papers provide helpful insights on the use of historical trial data, along with associated challenges and opportunities, to provide guideposts and use cases for the industry in drug development for both during and beyond COVID-19.
  • The Clinical Content and Reuse Initiative led a webinar on clinical study report considerations for studies disrupted by COVID-19. Watch a recording of the webinar here.
  • The eSource Initiative helped support the development of the Clinical Research Sponsor Laboratory Semantics in FHIR Implementation Guide (IG). The guide, published by Health Level Seven International (HL7®) and adopted as a standard for trial use, provides direction for using HL7’s Fast Healthcare Interoperability Resources (FHIR®) as a data transmission format for laboratory data, establishing a common format that is intended to reduce both site and sponsor burdens. Additionally, the SCDM eSource Implementation Consortium has expressed interest in using IG as a basis for developing requirements and guidance for sites to set up their FHIR®-based EHR environments. Find more information, including a list of FHIR® resources, here.

Enhance Drug Safety
Objectives

Facilitate solutions that address a common set of challenges in drug safety surveillance such as engaging the public, collaborating with regulators, incorporating data and analytics, developing model approaches, and assessing the impact of efforts.

  • The Intelligent Automation Opportunities (IAO) in Pharmacovigilance Initiative launched a new version of the Interactive ICSR and Automation Technologies Tool (IATT). The new IATT serves as a platform to report technology implementation data within the same ICSR Process map structure as the original tool. Additionally, the team has added a Case for Adoption resource that will help companies better understand and utilize TransCelerate’s IAO solutions as they explore the use of intelligent automation for pharmacovigilance.
  • The Advancing Safety Analytics (ASA) Initiative published an infographic, “Investigating Overlap in Signals from EVDAS, FAERS, and VigiBase.” This infographic illustrates the results of their Drug Safety manuscript that indicates, for the majority of drugs, that there is no significant difference between the number and types of safety signals that arise from the three main data sources. Instead, each database by itself may constitute a valuable tool for signal detection.

The Latest

Introducing the Vulcan HL7® FHIR® Accelerator

Spotlight

The Modernizing Clinical Trial Conduct Initiative


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