Formats

Webinar to Provide Findings & Reflections from CTTI’s ICH E6 Renovation Work

Posted on by Hannah Faulkner

As the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) begins revisions to ICH E6 GCP, new CTTI research highlights opportunities for changes and improvements.

CTTI will host a webinar Thurs., March 19, at noon ET providing an overview of new multi-method research to identify areas within ICH E6 GCP that are in the greatest need of renovation. Speakers will include:

  • Fergus Sweeney (EMA)
  • Celia Witten (FDA, CBER)
  • Amy Corneli (CTTI)
  • Dagmar Gortz (Janssen)
  • Pamela Gonzalez (University of Chicago)

CTTI’s research includes the perspectives of more than 350 research professionals in 20 different global regions and describes stakeholder experiences with implementing ICH E6 GCP. Preliminary findings were presented to the FDA and EMA in advance of the first ICH E6 work group meeting in November 2019. Some of the initial findings include:

  • 32.4 percent of respondents use mobile applications for the remote capture of efficacy or safety outcomes data for regulatory decision making
  • 62.1 percent use routine health care data for capture of efficacy or safety outcomes data for regulatory decision making
  • 60-75 percent of survey respondents indicated that renovation is not needed to the general principles
  • Areas identified as needing the most renovation included: Sponsor, Essential Documents, and Investigator. Of less need for renovation were topics in the section on Clinical Trial Protocol and Protocol Amendments.

To hear more, mark your calendar for the upcoming webinar today!

Webinar Now Available: CTTI Resources for Assessing the Value of Patient Engagement

Posted on by Hannah Faulkner

A recording is now available of a CTTI webinar held on Thurs., Feb. 27, which provided an overview of resources that can help you embed patient engagement in your research. The webinar, which was led by Joseph DiMasi (Tufts University) and Jaye Bea Smalley (formerly of Celgene), featured an overview on CTTI’s patient engagement work, including two tools for identifying patient engagement activities that bring high value to both sponsors and patient groups.

DiMasi discussed an economic modelling approach, along with recent findings, that can help sponsors and academic researchers measure the financial return on investment associated with patient engagement activities. The model developed by CTTI estimates the value of patient engagement on key business drivers such as cost, risk, revenue, and time. In a hypothetical scenario of oncology drug development, this model showed that benefits clearly outweighed the costs of engaging patients in clinical trials.

Smalley walked webinar attendees through another CTTI tool that helps sponsors and patient groups identify high-value opportunities to work together. The tool supports both groups in identifying potential engagement opportunities across the R&D continuum, qualitatively evaluating costs and benefits, and agreeing on activities to pursue through collaborative discussion.

Explore additional CTTI work and resources associated with patient engagement on its Patient Groups & Clinical Trials project page.

Are you already using CTTI’s PGCT resources? We would love to hear your experience and feedback!

Improving the Quality Conduct and Efficiency of Clinical Trials with Training: Recommendations for Preparedness and Qualification of Investigators and Delegates

Posted on by Hannah Faulkner

Improving the Quality Conduct and Efficiency of Clinical Trials with Training: Recommendations for Preparedness and Qualification of Investigators and Delegates

CTTI Webinar to Provide Insight on How to Embrace the Value of Patient Engagement

Posted on by Hannah Faulkner

Engaging patients at every stage of clinical research is no longer a “should,” it is a “must”. And, from quick online tools to in-depth financial reports, there are resources that can help you embed patient engagement in your research.

The Clinical Trials Transformation Initiative (CTTI) will host a webinar on Thurs., Feb. 27, at noon ET focusing on actionable resources for identifying patient engagement activities that bring high value – financial and otherwise – to both sponsors and patient groups.

Presenters Joseph DiMasi, Tufts University, and Jaye Bea Smalley, formerly with Celgene, will discuss:

  • New findings on the factors that sponsors and patient groups should consider when evaluating potential engagement activities.
  • Resources for sponsors to build their own financial model that can be used to estimate the value of patient engagement on key business drivers such as cost, risk, revenue, and time.
  • An online prioritization tool that patient groups and sponsors can use to collaboratively identify high-value opportunities to work together.

New Paper Offers Suggested Solutions for Improving Good Clinical Practice Training

Posted on by Hannah Faulkner

CTTI has released a new preprint paper detailing its findings from a project designed to assess challenges and burdens associated with Good Clinical Practice (GCP) training.

The paper, “More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant,” outlines feedback on GCP training gleaned from interviews CTTI conducted with clinical investigators and research sponsors. While interview respondents recognized that GCP training addresses critical tasks necessary for the quality conduct of clinical trials, many found it burdensome and repetitive—one interviewee said the training was seen as “just another box to check off.”

CTTI’s paper also highlights respondents’ suggestions for navigating these challenges, noting a need for significant improvement in the design, content, presentation, and training of GCP guidelines. These findings, together with other evidence, informed CTTI’s Investigator Qualification recommendations for alleviating the burden of training and making it more engaging and applicable to real-world clinical research scenarios.

Webinar Recording Now Available: CTTI’s Framework for Evaluating the NIH Single IRB Policy

Posted on by Hannah Faulkner

A recording is now available of a CTTI webinar held on Thurs., Jan. 16, which provided a recap of resources available to help implement a sIRB model, as well as an overview of a recent project CTTI undertook to develop a framework that could help in evaluation of the NIH’s single IRB (sIRB) policy. The webinar was led by Cynthia Hahn (Integrated Research Strategy), Stephen Rosenfeld (Secretary’s Advisory Committee on Human Research Protections), and Heather Pierce (Association of American Medical Colleges).

CTTI has been involved in driving adoption of sIRBs for over a decade, but its recent work with the NIH is especially critical this month as changes to the Common Rule take effect, requiring all multi-site research studies to use a sIRB for review.

To develop its evaluation framework, CTTI conducted a literature review and interviews with a diverse set of stakeholders engaged in the process of sIRB adoption.

The webinar outlined the framework’s recommendations for measuring and continuously improving the sIRB model, including:

  • Creating a database of organizations that are implementing the sIRB model, as well as which organizations are serving as an sIRB.
  • Developing and testing a survey instrument to help evaluate sIRB function and collect metrics.
  • Establishing, defining, and routinely collecting and sharing metrics, such as sIRB review time and time spent performing other sIRB-related activities. The team pointed out that although many metrics are quantitative, it is also important to have qualitative metrics to assess the overall quality of the sIRB process. Routine sharing of these metrics would serve to encourage improvement and eliminate unnecessary duplication.

Explore CTTI’s existing resources and recommendations for sIRB adoption on the CTTI website.

CTTI Holds First Meeting to Drive Appropriate & Efficient Use of Master Protocols

Posted on by Hannah Faulkner

Despite a growing enthusiasm for the use of master protocol studies, expertise is critically limited and few resources exist to guide planning and implementation. Working to fill this gap, CTTI held its first Master Protocol Studies expert meeting on Oct. 22-23 to identify strategies, tools, and resources that will help drive appropriate and efficient use of master protocols.

Attendees discussed challenges and potential solutions to planning and running master protocol studies. They also uncovered and agreed on some important common themes:

  • The Value is Clear…Master protocol studies are growing in popularity. Their flexible design and highly centralized operational features have the potential to more efficiently ask and answer scientific questions.
  • …But a Roadmap is Needed…However, many organizations lack experience in running master protocol studies, presenting major study design and operational challenges.
  • …As is Support for Non-Traditional Drug Developers. Publicly available resources are needed to support organizations that want to design a master protocol trial, particularly for non-traditional drug developers such as patient advocacy groups and other nonprofits.
  • Be Excited, but Realistic. Enthusiasm for a master protocol approach should be balanced with awareness of its complex infrastructure, long-ranging timelines, and significant upfront planning and resources.
  • There are Keys to Long-Term Success. A strong cross-institutional infrastructure, including a robust site network and solid communications approach, are critical to achieving long-term sustainability of master protocols.

Based on these discussions and findings, attendees refined CTTI’s draft roadmap for the successful design and implementation of master protocol studies, and identified a broad set of tools and resources that can drive adoption of master protocols across diverse therapeutic areas.

Learn more about CTTI’s Master Protocol expert meeting and next steps with work to advance master protocol adoption.