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Quarter Q2

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

  • In June, BioCelerate announced the release of its first set of solutions as part of its Public Private Partnership (PPP) with the U.S. Food & Drug Administration’s Center for Drug Evaluation and Research (CDER) Office of Computational Science (OCS). One of the goals of this PPP is to help optimize the implementation of the Clinical Data Interchange Standards Consortium’s (CDISC) Standard for Exchange of Nonclinical Data (SEND) so nonclinical data is presented in a harmonized format across the ecosystem to facilitate cross-study analysis.
  • DIA Global 2021 finished on July 1 after four days of TransCelerate and Member Company sessions. At the conference, TransCelerate received DIA’s Global Inspire Award for Author of the Year for the paper “Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities.” To read the full recap of our sessions, click here.
  • We welcomed Rob Lenz, M.D., Ph.D. of Amgen to our Board of Directors. He will assume the role for Elliott Levy (Amgen), who will be stepping down. Rob currently serves as Senior Vice President, Global Development, responsible for the clinical development of Amgen’s pipeline. We look forward to Rob bringing his immense industry experience to TransCelerate’s collaborative Board of Directors members.
  • We welcomed Karin Kramer Nielsen (Novo Nordisk) who will be assuming the role of Oversight Committee Chair for Simon Trowell (GSK). Karin currently serves as Corporate Vice President, Data Management and has been with Novo Nordisk since 1994. We look forward to Karin’s global industry experience and leadership in this new role.

Pulse On Progress Updates

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.

  • The Clinical Content & Reuse (CC&R) Initiative released Japanese (日本語) translations of the Common Protocol Template (CPT) and Patient Library. Translations are available on CC&R’s Solutions page, at Clinical Content & Reuse Assets – Clinical Studies, and under Solutions Available in Additional Languages.
  • In mid-2018 and into 2019, the TransCelerate eSource team engaged with a Site Advocacy Group (SAG) in collaboration with the Society for Clinical Research Sites (SCRS) for an information gathering exercise via voluntary site survey to discuss challenges and areas for improvement in conjunction with technology use in clinical trials. The eSource Informatics Continuum and Reference Guide for Clinical Research Sites provides information on clinical research informatics, the basics of informatics, and possible resources to expand capabilities around interoperability and data exchange for clinical sites.

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.

  • Throughout the COVID-19 pandemic, our Patient Technology Initiative was one of the teams recognized as having produced valuable solutions with applicability to the changing industry landscape. To modernize key solutions for use in the “new normal,” the Patients Considerations Guide and Patient Technology Site Feedback Questionnaire (PTSFQ) were updated to include considerations around decentralized trials and virtual environments. The full list of Patient Technology assets are available on its Solutions page.
  • TransCelerate’s Privacy Methodology for Data Sharing initiative recently completed its first-ever Initiative poster, which is now live on the DataCelerate® webpage. The Privacy Methodology Initiative supports TransCelerate’s greater Information Sharing strategic program and the DataCelerate® platform. This initiative aims to identify a model approach to implement privacy safeguards that will provide increased transparency and enable simpler utilization of clinical trial data reuse within the DataCelerate® modules.
  • The newly launched Diversity of Participants in Clinical Trials Initiative seeks to move beyond our prior awareness building activities and begin to equip sponsors and ecosystem stakeholders with the actionable tools and resources needed to improve outcomes for diversification of participants in clinical trials. As part of the first phase of the initiative, the following efforts are underway: a Member Company clinical research diversity collaboration hub, race and ethnicity enrollment data benchmarking, leveraging existing solutions, and best practices for sponsors and clinical trial sites.

Enhance Sponsor Efficiencies
Objectives

Facilitate the advancement of innovative healthcare and clinical research through improved technologies, advanced data collection systems and simplified processes.

  • CDISC published its CDASH SAE V2.0 Supplement, which captures how to structure serious adverse events (SAE) concepts for regulated clinical trials. This supplement aligns with E2B (R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide—Data Elements and Message Specification. This standard issuance would not be possible without TransCelerate’s hard work in 2019 through our Common SAE Fields Initiative and the gathering of input from both our clinical and pharmacovigilance sides of our portfolio. In only four months, the Common SAE team conducted a comprehensive landscape assessment to understand the applicable current industry regulations. They identified the common core fields collected and reported following a serious adverse event. The proposed list contained 833 unique fields and through the team’s analysis, the list was pared down to approximately 130 unique fields spread across nine sections of data. The result was the “Common SAE Fields Project Overview & Outputs” slide deck and methodology. Once complete, TransCelerate transitioned this deliverable to CDISC’s CDASH SAE Standard team in Q4 2019. CDISC has worked for the past year to develop this new industry standard surrounding SAE data collection.
  • TransCelerate’s Modernizing Clinical Trial Conduct (MCTC) Initiative, in collaboration with the Risk Based Monitoring (RBM) Initiative, released a new publicly-available report that organizations can use to help benchmark their RBM activities pre-COVID-19. Key findings from a voluntary 2020 survey conducted in TransCelerate Member Companies pre-COVID, regarding their Risk Based Monitoring practices related to Source Data Verification (SDV) and Source Data Review (SDR), are summarized in “Results of RBM SDV/SDR Survey: 2020 Pre-COVID-19 Pandemic Practices.” This report serves as the final deliverable of the recently completed RBM Initiative.
  • Modernization of Statistical Analytics launched its Foundational Framework along with many supporting resources to aid in awareness and adoption. The framework seeks to explore a product agnostic approach to build trustworthiness in modern statistical software tools which includes principles that can be used across the industry to establish a high level of accuracy, traceability, and reproducibility. The team developed an infographic and case for adoption to help socialize these concepts.
  • TransCelerate’s Protocol Deviations (PD) initiative team published a peer-reviewed article, “Protocol Deviations: A Holistic Approach from Defining to Reporting.” Protocol Deviation Management processes can be complex and varied, making it difficult to navigate the clinical trial landscape in R&D. Especially with COVID-19 altering many clinical trial operations, protocol modifications will be necessary to ensure sponsors conducting clinical research can improve their PD classification, collection, analysis and reporting processes.

Check Out Our Blog

Learn about what we’ve been up to this past quarter:


The Latest

A Framework for Evolving Analytics and Modernizing Software Technologies in Clinical Development

The Spotlight

BioCelerate’s SEND Implementation for Cross-Study Analysis Initiative

Mark Your Calendars

TransCelerate leaders and Member Companies are invited to participate and present at many biopharmaceutical research industry conferences and meetings across the globe to provide a perspective on industry challenges and clinical trial issues. Take a peek at a few places we will be presenting in the coming months. For detailed information on speaker presentations, visit the events page on the TransCelerate website.

July 13-14, 2021

SCRS Asia-Pac

Virtual Attendance

July 26-27, 2021

National Academies of Sciences, Engineering, and Medicine – National Cancer Policy Forum Workshop

Virtual Attendance

September 7, 2021

DIA Pharmacovigilance Strategies Workshop

Virtual Attendance

September 13-15, 2021

PHUSE Computational Science Symposium (CSS)

Virtual Attendance

September 21-24, 2021

ASA Biopharmaceutical Section Regulatory-Industry Statistical Workshop

Virtual Attendance


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