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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

  • TransCelerate announced the expansion of access to COVID-19-related patient-level clinical data sharing via DataCelerate® to non-member companies and biopharmaceutical research agencies that meet certain qualifications. More information on the criteria is available here. This announcement quickly follows a decision to utilize the DataCelerate® platform to share control arm data from ongoing and planned COVID-19 clinical studies.
  • Peter Ronco, Head of Global Development at Janssen R&D, was nominated by Johnson & Johnson to be its new representative to the TransCelerate Board of Directors.
  • TransCelerate attended the virtual DIA 2020 Global Annual Meeting and presented 15 sessions throughout the four-day conference in June. For a full recap of the event, read this post.
  • TransCelerate held two virtual webinar panels on “Exploring How TransCelerate Solutions Can Enable Clinical Trial Continuity.” The panel explored how existing TransCelerate solutions can support Clinical Trial Continuity during times of disruption. View the full sessions here

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.

  • The Clinical Research Access & Information Exchange (CRAIE) Initiative team published a paper in PLOS ONE, “Patient preferences when searching for clinical trials and adherence of study records to ClinicalTrials.gov guidance in key registry data fields.” The paper describes the results of a global survey on the information preferences of patients when looking to participate in a trial and provides an analysis of current ClinicalTrials.gov entries in regard to their patient friendliness and adherence to guidelines. The paper concludes that sponsors should make ClinicalTrials.gov entries more user friendly to facilitate patient access to clinical studies.
  • The CRAIE Initiative team also published an infographic, “What Patients Want to See in Clinical Trial Registries.” The infographic, based on a global patient survey with 1,070 responses, details what information is helpful when patients begin their search for clinical trials in a registry and what information patients find important.

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 and Reuse (CC&R) Initiative released a new solution, the Clinical Study Report (CSR) Considerations for Studies Disrupted by the COVID-19 Pandemic. This document was created by clinical scientists, pharmacovigilance experts, data scientists, and other professionals to identify the important topics that clinical researchers and research sponsors may consider as they adapt their studies and clinical study reports due to disruptions caused by COVID-19. At this time, no further updates to this content are planned, though TransCelerate will be seeking further input from experts and regulators to guide CSRs for studies disrupted by COVID-19.
  • The Digital Data Flow (DDF) workstream conducted a virtual Hackathon to evaluate feasibility for the study design component of the DDF Vision. The DDF Hackathon attracted 175 participants across 15 entries to provide innovative solutions to meet user needs described in 15 user stories, which aim to help transform the workflow from document-based to a content driven-data, design, workflow, and management environment. All 15 entrants’ prototypes provided valuable insight to the challenge of study start up digitization and process automation. The judging panel ultimately selected three entries as Distinguished Submissions: Microsoft & InteliNotion, Nurocor, and Trials.ai.
  • The Placebo and Standard of Care Initiative is rebranding to a new name: Historical Trial Data Sharing (HTD) (Controls). This name change has been made so the initiative title better reflects the team’s work: enabling the sharing of historical trial data to maximize the value of clinical data collected in the control arms of clinical trials. Though the name is changing, the team’s valuable work continues.

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 (IAO) in Pharmacovigilance Initiative added the 2020 Technology Matrixto their assets page. The 2020 Technology Matrix provides information regarding the types of intelligent automation technologies available in pharmacovigilance and maps what technologies have been implemented in connection with specific Individual Case Safety Report processes.
  • The Interpretations of Pharmacovigilance Guidances & Regulations (IGR-PV) and the Interpretations of Clinical Guidances & Regulations (IGR) Initiatives launched their new asset pages. Each guidance or regulation now has its own page describing the topic and lists all associated assets in a single linkable location. The IGR PV and IGR Clinical assets were developed as part of the mission to share expertise to more efficiently and effectively meet the intent of what are historically ambiguous regulations, guidances and operational expectations around the world. Secondarily, the initiatives take opportunities to raise Health Authority awareness of the real-world impact of ambiguous regulations and guidelines.
  • The Advancing Safety Analytics (ASA) Initiative published a paper, “Signal Management: Current Landscape and Considerations for Best Practices.” This paper reviews the current landscape of signal management and proposes a simplified, end-to-end framework while highlighting some best practices. The ASA team collaborated to understand end-to-end signal management and the unique value or contribution of publicly available data sources.

The Latest

Key Considerations for Clinical Study Reports for Studies Impacted by COVID-19

We spoke with Elizabeth Bygate, former Director at GlaxoSmithKline, about adapting clinical study reports to reflect disruption that may have occurred due to COVID-19.

Spotlight

The Patient Technology 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 early next year. For detailed information on speaker presentations, visit the events page on the TransCelerate website.

August 11, 2020, 10:00AM - 11:00AM

Clinical Study Report Considerations That Have Been Interrupted by COVID-19

TransCelerate Webinar

August 18-19, 2020

DIA Digital Technology in Clinical Trials

Virtual Attendance

September 1-2, 2020

World Drug Safety Congress Americas

Virtual Attendance

September 9-11, 2020

KoNECT-MOHW-MFDS International Conference

Virtual Attendance

September 13-16, 2020

SCDM

Virtual Attendance

September 21-23, 2020

PhUSE 2020 Computational Science Symposium

Virtual Attendance

September 22-23, 2020

DPharm: Disruptive Innovations US 2020

Virtual Attendance

September 22-23, 2020

World Drug Safety Conference Europe

Beurs van Berlage, Amsterdam


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