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CTTI Unveils New Recommendations for Using Real-World Data Sources to Boost Trial Quality and Efficiency
CTTI today released new recommendations, resources, and case studies for using electronic medical records (EHRs) and claims data to plan trial eligibility criteria and recruit participants. The work fills an important gap across the clinical trials ecosystem, where the potential benefits of real-world data (RWD) have been widely acknowledged, but few resources have emerged to lead sponsors and others through the process of formally integrating RWD into their trial designs.
“We are excited to unveil this comprehensive set of work, which enables the use of RWE to plan for appropriate eligibility criteria and optimal recruitment in clinical trials,” said CTTI Executive Director Pamela Tenaerts. “These recommendations add to CTTI’s growing portfolio of work focused on improving clinical quality and, when appropriate, embracing novel approaches for better trial design and execution.”
CTTI conducted research and collaborated with stakeholders across the clinical trials ecosystem to develop these recommendations and resources, including three case studies that elucidate the process of integrating RWD into trial design. The case studies offer a look into the specific challenges faced by each sponsor, how they used RWD to address those challenges, and what they learned along the way.
Other CTTI efforts related to the new work include:
- Co-leading a proof-of-concept study to assess the feasibility of using the FDA Sentinel System infrastructure to conduct randomized clinical trials.
- Recommendations on how to assess and design registries so that the data can meet expectations for the FDA review of new products.
- Recommendations and a robust toolkit to help drive a Quality by Design (QbD) approach, which engages a broad range of stakeholders and focuses resources on the errors that matter to decision making.
The RWD recommendations, resources, and case studies can be found on CTTI’s website.
CTTI to Launch New Work Highlighting the Opportunities for Using Real-World Data to Enhance Trial Quality and Efficiency
CTTI will host a public webinar on Thurs., Oct. 17, to announce new recommendations, resources, and case studies on how to use real-world data (RWD) to evaluate trial eligibility criteria and recruit potential participants.
“Until now, there have been few resources available to help sponsors and others optimally integrate the use of RWD into their trial design,” said CTTI Executive Director Pamela Tenaerts. “The work we are launching today fills that gap—our new recommendations and resources provide a clear path for using EHR and claims data to help plan eligibility criteria and recruit for clinical trials in a way that enhances quality and efficiency.”
CTTI conducted research and collaborated with stakeholders across the clinical trials ecosystem to develop these recommendations and resources, including three in-depth case studies that detail the specific challenges faced by sponsors, how they used RWD to address those challenges, and what they learned along the way.
This project is one in a growing portfolio of CTTI work focused on improving quality in trials and embracing novel trial designs. Other related CTTI efforts include:
- Recommendations and a robust toolkit to help drive a Quality by Design (QbD) approach, which engages a broad range of stakeholders and focuses resources on the errors that matter to decision making.
- Co-leading a proof-of-concept study to assess the feasibility of using the FDA Sentinel System infrastructure to conduct randomized clinical trials.
- Recommendations on how to assess and design registries so that the data can meet expectations for the FDA review of new products.
The webinar is open to the public and will begin at noon ET, featuring speakers Sudha Raman, Duke University, and Jack Sheehan, Johnson & Johnson/Janssen.
CTTI Unveils New Resources to Facilitate Implementation of Single IRB for Multicenter Trials
CTTI has announced new resources to facilitate the implementation of single IRB (sIRB) in multicenter trials. The tools walk research institutions, sponsors, and IRBs through considerations for determining engagement, and provide a library of available sIRB resources. They are enhancements to CTTI’s extensive work on the topic dating back to 2010, which was featured in a recent issue of Contemporary Clinical Trials Communications.
“For nearly a decade, CTTI has been at the forefront of the sIRB movement, championing the thoughtful implementation of sIRBs for multicenter clinical trials to enhance patient safety, accelerate study start-up, and improve trial conduct,” said Pamela Tenaerts, executive director of CTTI. “We are pleased to unveil new resources to address some of the most pressing sIRB challenges and information gaps that remain for researchers. These tools augment CTTI’s already robust set of resources to collectively make sIRB adoption more seamless for the clinical trials enterprise.”
CTTI’s new tools include:
- A set of Engagement Materials including:
- An Engagement Overview, which provides an introduction to the Engagement Materials, information about who has the authority to make engagement decisions, required information to assess, and responsibilities of an engaged institution.
- An Engagement Flowchart, which guides institutions through a set of questions for determining if its employees or agents are performing activities that constitute “human subjects research” on the institution’s behalf as defined by the Office for Human Research Protections (OHRP).
- An Engagement Scenarios Guide, which illustrates examples of institutional involvement in research that would be considered “engaged” versus “not engaged.”
- Engagement Definitions for terms used in the Engagement Materials.
- A Resource of Resources that offers a library of available sIRB guides, templates, and tools to help stakeholders to optimally prepare, engage, and implement sIRB.
More information on these new resources is available via a recent CTTI-hosted webinar that features Nichelle Cobb (University of Wisconsin-Madison) unveiling the tools and showcasing their utility. The webinar also includes an overview of CTTI’s previous and ongoing work on sIRB for multicenter clinical trials, as well as results of recent semi-structured interviews to assess current perceptions of sIRB benefits, process challenges and solutions, and informational needs for using an sIRB process for FDA-regulated studies.