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Quarter 1

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, health authorities, 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

  • Our email subscribers now can personalize the frequency and types of communications they receive by signing up for the TransCelerate Awareness & Implementation Community. By signing up for this community, subscribers will be provided timely and relevant information based on interests and data provided.
  • In January, Board Member Stuart Poulton transitioned out of his role as AbbVie Board Member and TransCelerate welcomed Neil Gallagher back to the Board of Directors in this position. We thank Stuart for his leadership and dedication to TransCelerate.
  • In April, Rod MacKenzie (Pfizer) retired as Chair of the Board of Directors and previous Vice Chair Kate Owen (BMS) assumed this role. Additionally, TransCelerate welcomed four new Board of Directors Members: William Pao (Pfizer), Eliav Barr (MSD), Christoph Koenen (Bayer), and Maria Koutsopoulou (Merck KGaA). We look forward to welcoming these new members’ expertise and leadership within TransCelerate’s Board of Directors.

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 Digital Data Flow (DDF) Initiative, in collaboration with CDISC, made significant progress as draft CDISC standards supporting the DDF initiative entered the fourth and final internal review period. Draft CDISC standards will be incorporated into the DDF initiative’s launch of a Study Definitions Repository Reference Implementation (SDR RI) this spring. Final, published CDISC standards will be released later this year after completing a formal Public Review process.
  • The Clinical Content & Reuse (CC&R) team published the white paper “Examining Possibilities for a Consistent Procedures Library to Modernize Clinical Trials: A TransCelerate Point of View.” This paper was developed to share the findings of a working group who explored if there were existing controlled terminologies that could describe clinical protocol procedures more consistently. This paper complements work being done within other TransCelerate workstreams, such as DDF and eSource as well as the HL7 Vulcan team, in which TransCelerate contributes.
  • The Privacy Methodology for Data Sharing Initiative has released its first solution! The Educational Toolkit for Clinical Data Reuse contains an educational poster and supporting materials, both of which explain the approaches used to protect patient privacy in layperson’s terms. Use of the Educational Toolkit could increase patient understanding and confidence in clinical trials data management and how this relates to the protection of their personal data. The FAQ provides important context about the educational tool and can aid study sponsors in answering common questions asked by IRBs and Ethics Committees related to patient privacy.
  • The Clinical Content and Reuse team has updated its Japanese version of the Basic Word Edition Core Template and the Patient Library. The Basic Word Edition Core Template is comprised of a common heading structure, proposed model content, and has also been translated contains content pertinent to studies in patients. You can find both of these translated assets here.
  • The Digital Data Flow (DDF) Initiative released a video overview of their initiative and how its deliverables can be used to organize and automate the data and information in a study protocol. This can then help industries transform how studies are designed and delivered.

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.

  • The Patient Experience Initiative is building upon TransCelerate’s mission to collaborate across the global biopharmaceutical research and development community by seeking feedback on how to evolve our Study Participant Feedback Questionnaire (SPFQ) Toolkit. This toolkit was created to help study sponsors gather patient feedback during clinical studies. The current SPFQ consists of a set of three separate questionnaires offered at the beginning, middle, and end of a study along with a socialization presentation and user guide. To submit topics and questions that should be included, complete the survey here. The survey is open through July 15, 2022.
  • The Diversity of Participants in Clinical Trials Initiative held a cross-consortia Diversity Roundtable event in Fall 2021. Nine organizations were represented in the roundtable event which aimed to improve transparency and generate insights about efforts to increase diversity in clinical trials, identify opportunities for collaboration to enhance ongoing actions and address underserved areas needed to improve diversity in clinical trials, and inform the development of actionable takeaways and materials to support implementation of solutions to increase diversity in clinical trials. As a result of this meeting, the Diversity of Participants in Clinical Trials team developed and launched the U.S. Regulatory Landscape: Diversity in Clinical Trials resource. This regulatory landscape resource is designed to help identify key U.S. legislation and U.S. FDA policy, regulation, and guidance as well as regulatory precedent to consider when working to understand and improve diversity & inclusion (D&I) of adult patients in clinical trials, focusing on the inclusion of racial and ethnic minorities. In future phases of work the team will look to expand the landscape assessment to include other geographies.
  • TransCelerate’s Patient Experience 2021 Global Impact Survey results showed that while many companies are seeing benefits from using the Patient Protocol Engagement Toolkit (P-PET). Yet it was clear that opportunities still exist to help sponsors and other stakeholders utilizing the P-PET start to measure benefits. To support this effort, the Patient Experience team recently re-launched this asset to include ways to identify opportunities for measuring benefits realized through P-PET implementation. We’re excited to share that the updated P-PET User Guide is now available on the Patient Experience Solutions page.

Enhance Sponsor Efficiencies
Objectives

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


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 in Pharmacovigilance team released a video, “Validating Intelligent Automation Systems in Pharmacovigilance,” now available for viewing on the Interactive ICSR and Automation Technologies Tool Page and YouTube. The video is based on the most recent conference presentations by the team’s validation subject matter experts and provides an in-depth overview of TransCelerate’s paper, “Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices.” Read the full validation paper here, which provides strategies to help facilitate further dialogue and collaboration between Health Authorities and the R&D ecosystem.
  • The Pharmacovigilance Agreements Optimization (PVAO) team just launched
    a Glossary demo video which discusses the newest release from the PVAO Initiative. This solution can help stakeholders operate more efficiently through all phases across the PVA lifecycle by supporting a common understanding of key terminology and definitions.

Check Out Our Blog

And if you haven’t already, check out our recent blog posts and media placements to learn about what we’ve been up to this past quarter:

 


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Keep Up with Us!


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.

April 20, 2022

Vulcan 101: Bringing FHIR to Clinical Research

Virtual

April 20-21, 2022

SCOPE Europe 2022

Virtual and in-person in Barcelona, Spain

May 1-5, 2022

PHUSE US Connect

Atlanta, U.S.

May 11, 2022

Digital Data Flow: Modernizing Clinical Trials, Updates on Progress and Cross-Industry Collaboration (Part 2)

Virtual

May 17-19, 2022

Pharma Clinical 2022

Virtual

May 20, 2022

SCRS Diversity Site Solutions Summit

Austin, U.S.

May 23-25, 2022

ARCS Australia Annual Conference

Sydney, Australia

June 19-23, 2022

DIA Annual Meeting

Virtual and in-person in Chicago, U.S.


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