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Quarter Q1

Pulse on Progress Q1 2020

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 invision this happening 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 response to the COVID-19 crisis, TransCelerate shared that it is providing Member Companies a trusted and collaborative forum to discuss the ongoing disruption to drug development and shared its tools that can be referenced by sites and sponsors to support the continuity of clinical trials.
  • TransCelerate announced Bayer as its newest member. Steffen Roellinger, SVP, Head of Clinical Operations will serve as TransCelerate’s newest Board Member.
  • TransCelerate’s CEO Dalvir Gill was recognized as one of the Philadelphia Business Journal’s 2019 Most Admired CEOs.
  • TransCelerate attended the 11th Annual Summit for Clinical Ops Executives (SCOPE) in Orlando and presented nine sessions throughout the four-day conference.
  • TransCelerate recently published a manuscript in the Japanese journal Medical Device Regulatory Science. This manuscript, published exclusively in Japanese, highlights TransCelerate’s activities in Japan, mission and solutions, serving as an excellent introduction of the organization.

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 Awareness team published a paper, “Clinical Research Awareness: A proposed study design to assess the role of shared decision making in the consideration of clinical trial participation.” This paper outlines a study designed to test whether Shared Decision Making communication techniques, tools and training can enhance the decision-making experience for patients and their healthcare provider team while patients consider their options inclusive of clinical trial participation.
  • The Patient Technology (PT) team released its redesigned assets page, complete with a toolkit that helps users approach implementation of patient technology strategically with long-term goals and scalability in mind. The interactive page guides users through the toolkit step-by-step, offering supportive documents for each phase. The team has also released new tools for the Patient Technology journey, including:
    • A Patient Considerations document, developed in partnership with patients, enables study teams to think critically about how their decisions to utilize PT will impact study participants.
    • A gifographic titled, “Using Vendor Perspectives to Implement Patient Technology in Clinical Trials,” that describes key findings from surveys and interviews with patient technology vendors.
    • The Vendor and Sponsor Engagement Considerations document, developed using input from vendors, provides topics and questions for study teams to discuss during and after implementation of PT in clinical trials.
    • An updated Regulatory Landscape Tool, which provides an overview of U.S. and European Health Authority regulations and guidances related to digital technologies and their use in clinical trials.
  • The Patient Technology Initiative also published a team-authored whitepaper, “A Shared Perspective of Patient Technology Implementation in Clinical Trials.” The paper shares key findings, insights and learnings from the PT initiative’s first-of-its-kind exercise in knowledge sharing.
  • The Clinical Research Access and Information Exchange (CRAIE) Initiative continued its momentum to make clinical trials more accessible to patients by improving the usability of ClinicalTrials.gov. The team is responding to the National Institutes of Health’s (NIH) public Request For Information process to modernize ClinicalTrials.gov. The team is leveraging the previous work TransCelerate developed for the Registry of the Future concept, which includes information from patients, sites and other stakeholders on what they value when searching for trials.
  • The Risk Based Monitoring (RBM) Initiative published a new report, “Measuring The Impact of Risk Based Monitoring.” The document provides a detailed look into the past, present and future evolution of RBM Metrics, lessons learned, and best practices for defining and measuring RBM value to stakeholders through metrics and future trends. The team also hosted an educational webinar, which highlighted the information in this new asset and invited several member companies to discuss their experiences with measuring RBM impact. Watch the full webinar here.

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 translated two documents, the Common Protocol Template and Patient Library, into Japanese. The goal of these newly translated documents is to increase potential use by the broader global community. Download the resources here.
  • The Digital Data Flow (DDF) Initiative released its new assets page. The site offers visitors a range of tools to help enable the flow of digital study protocol data to improve study design and accelerate start-up through automation of processes and setup of study execution systems. These resources include:
    • A short informational video explaining the Digital Data Flow concept.
    • A Solution Framework and Conceptual Design (SF&CD), which helps technology providers create an innovative, central protocol platform that will be accessible, open, flexible and vendor-agnostic toward downstream clinical applications.
    • An SF&CD Executive Summary that provides a high-level overview of a potential SF&CD that would optimize processes and automate asset development from study concept finalization through study start-up (SSU).
    • An appendix that describes a technology-enabled business process for defining a clinical study design that could be supported by a study builder platform.
  • Additionally, the DDF Initiative launched its official virtual Hackathon website. This virtual hackathon, which launched on March 9 and concludes at the end of April, is seeking developers and vendors to participate and create solutions based on specific requirements from the DDF team. During the hackathon, multiple vendors are developing technical demonstrations of components of a study builder, design repository, and/or an exchange platform. The learnings from the hackathon will be used to inform design elements and the future direction of the DDF project. Those interested in learning more can watch the webinar or download the slides here.
  • TransCelerate announced that 109 previously converted and harmonized studies have been migrated and their data is now available in DataCelerate® for historical control arm data sharing. DataCelerate® is a global technology platform that allows for multiple de-identified/anonymized research and development data types to be voluntarily submitted, uploaded, converted, harmonized, and downloaded through an access-controlled, secured environment.

Enhance Sponsor Efficiencies
Objectives

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

  • The Protocol Deviations Initiative released its brand new assets page. With the COVID-19 pandemic drastically affecting clinical trial operations, sponsors are expecting an increase in protocol deviations. To help stakeholders navigate multiple aspects of protocol deviation (PD) management, TransCelerate expedited the release of its toolkit and new website. Confusion in the definition of a PD may contribute to both over- and under-reporting of deviations which impacts sponsors, sites, and patients. The toolkit offers clarification of the definition and provides a holistic approach to protocol deviations management. The toolkit includes:
    • A process guide, which outlines a proposed framework describing flexible PD management approaches, elements for consideration based upon interpretation of the ICH E3 definition for important PD and other associated PD guidance.
    • A process map of the PD management process containing processes for both important and non-important deviations.
    • A decision tree to guide in the identification and classification of important and non-important protocol deviations.
    • An assessment tool to assist in the identification and documentation of protocol-specific ‘important’ deviations.

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 (IAO) team has launched its assets page. The impetus of this launch is the Interactive ICSR and Automation Technologies Tool (IATT), which is an interactive process flow depicting each step within the individual case safety report (ICSR) process. Each ICSR process step will include the level of opportunity for process automation, as defined by (1) current level of effort, (2) level of benefit from automation and (3) level of risk from automation. Additionally, the IAO team released one of its foundational manuscripts in Pharmaceutical Medicine. The paper, “Automation Opportunities in Pharmacovigilance: An Industry Survey,” offers a systematic review framework for automation of the ICSR process from the value, impact, perceived risk, and opportunity point of view. The ICSR process was selected first for evaluation because of its resource-intensive nature, risk of errors, and operational inefficiencies.
  • The Advancing Safety Analytics Initiative launched its assets page, featuring the team’s first published paper, “Investigating Overlap in Signals from EVDAS, FAERS, and VigiBase®” in Drug Safety. The FDA’s Adverse Event Reporting System (FAERS) and VigiBase® are two established databases for safety monitoring of medicinal products, recently complemented with the EudraVigilance Data Analysis System (EVDAS). Signals of disproportionate reporting (SDRs) can characterize the reporting profile of a drug, accounting for the distribution of all drugs and all events in the database. This paper aims to quantify the overlap among the three databases when characterized by two disproportionality-based analyses (DPA).

The Latest

Bringing Intelligent Automation Technologies to Pharmacovigilance Activities

We spoke with Neal Grabowski, Safety Signal & Information Management Director, Global Patient Safety and Pediatrics at Amgen, about the expected value and level of opportunity that intelligent automation technologies will bring to the PV space.

Spotlight

The Patient Technology Initiative

We sat down with Peter Schaeffer, Third Party Risk and Oversight Analytics Director for GlaxoSmithKline, who has taken a lead role in TransCelerate’s Patient Technology Initiative to learn more.

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.

April 22, 2020, 11:30AM - 12:30PM

Patient Technology Tools for Industry: Designing Clinical Trials with Patient and Vendor Input

TransCelerate Webinar

April 30, 2020, 10:00AM - 11:30AM

Improving Efficiencies in Nonclinical Research: Developing & Implementing Common Toxicology Protocol and Report Templates

TransCelerate Webinar

June 14-18, 2020

DIA 2020 Global Annual Meeting

Washington D.C., United States

June 17-20, 2020

World PreClinical Congress Americas

Boston, United States

June 30-July 3, 2020

DIA Europe 2020

Brussels, Belgium


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