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CTTI Paper Discusses Development of Patient Group Engagement Tool to Benefit Clinical Trials

Posted on by Hannah Faulkner

Patient groups can offer sponsors a wealth of support that can boost clinical trial efficiency but there are few frameworks to help identify priorities. In a new preprint manuscript, CTTI discusses the development and application of an evidence-based prioritization tool to help sponsors and patient groups identify mutually beneficial engagement activities.

Using a list of 31 engagement activities previously developed through its Patient Groups and Clinical Trials (PGCT) work, CTTI conducted qualitative, semi-structured interviews with representatives from patient groups and sponsor organizations to refine the list to 24 unique engagement activities across the medical product development lifecycle.

The findings were used to develop the web-based tool, which helps sponsors and patient groups identify mutually relevant, high-priority engagement activities.

The manuscript explains how the tool walks users through a three-step decision-making process that results in a visual priority matrix grid. It helps sponsors and patient groups form meaningful partnerships and solidify expectations, goals, and specific roles that will benefit the design, conduct, and dissemination of research, in alignment with CTTI’s recommendations [link] for effective patient group engagement.

Read the full manuscript.

CTTI Paper Discusses Suitability of Patient Registries for Embedded Clinical Trials

Posted on by Hannah Faulkner

Embedding clinical trials into patient registries can lead to high-quality, efficient prospective research. However, methods for assessing which registries are appropriate to serve as the platform for the conduct of a clinical trial can be problematic for researchers. A new CTTI paper in Therapeutic Innovation & Regulatory Science identifies and describes the essential characteristics, processes, and practices required to embed and conduct registry-based clinical trials to support regulatory decision-making.

Taking an evidence-based, collaborative approach, CTTI completed a comprehensive review of registry-embedded clinical trials and worked with the Research Triangle Institute (RTI) to conduct 25 expert interviews. These efforts were followed by a multistakeholder meeting with 42 members of academia, industry, government, and patient advocacy organizations.

The resulting data indicates that registries can create a sustainable and reusable infrastructure to support embedded clinical trials when certain characteristics are present including relevancy, robustness, reliability, and assurance of patient protections.

What’s more, registry-embedded clinical trials offer opportunities to:

  • Identify high-quality sites
  • Reduce duplicative data and site workload
  • Recruit patients efficiently
  • Reduce lost to follow-up incidents
  • Enhance timelines
  • Reduce costs

CTTI noted a prevailing need for guidance on how to assess the suitability of existing registries and plan new registries that can support embedded clinical trials. The paper includes CTTI recommendations, suggested practices, and decision trees that help meet this need. These resources are designed to help clinical trial stakeholders effectively leverage patient registries to create high-quality, embedded clinical trials that benefit relevant patient populations.

Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative

Posted on by Hannah Faulkner

Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative

CTTI Feasibility Studies Database Adds New Resources

Posted on by Hannah Faulkner

CTTI has added 172 new studies to its Feasibility Studies database, bringing the total number of resources up to more than 440 studies. This free, one-of-a-kind repository of feasibility studies using digital health technologies to capture data in clinical research can help the entire clinical trials community to better match appropriate technologies to their research goals.

For example, sponsors can use the resource to help support trial design, while investigators in the field can use it to make decisions regarding which technology would be most useful for their research. This centralized repository could also help alleviate future development of redundant studies and contribute to the design and implementation of high quality, efficient trials.

The database includes a systematic search of scientific literature indexed in PubMed and published between January 2014 and June 2019.

Do you know about a study we should add to the database? CTTI invites others in the digital health trials community to submit relevant studies on an ongoing basis.

Recording Now Available: Strategies for Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Trials

Posted on by Hannah Faulkner

Given the recent statistics showing that COVID-19 disproportionately affects racial and ethnic minority communities, the recruitment and enrollment of diverse populations are crucial. In a webinar from Thurs., June 18, “Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Clinical Trials,” CTTI discussed the barriers to enrolling a diverse patient population and key strategies to overcome them. The presentation and full slide deck are now available here.

The webinar covers useful insights and best practices gathered from key stakeholders across the clinical trials ecosystem, including investigators, sponsors, participants, and many others.

Presenters included:

  • Christina Brennan, Northwell Health
  • Richard Knight, American Association of Kidney Patients
  • Fabian Sandoval, Emerson Clinical Research Institute
  • Anand Shah, FDA, OC
  • Cassandra Smith, Janssen

Several CTTI efforts are underway—including conducting surveys, holding webinars, and developing resources to help the clinical trials ecosystem adapt and move forward during this pandemic.

Web Conference Recordings Available: Listen to Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice

Posted on by Hannah Faulkner

A recording for FDA and CTTI’s two-day Pan-American web conference held June 4-5, “Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice,” is now available.

Khair ElZarrad, FDA, and Pamela Tenaerts, CTTI, opened the web conference by welcoming attendees. Then, FDA and CTTI shared background on ICH E6 and the plan to engage with stakeholders to inform the discussions of the ICH Expert Working Group (EWG), which is tasked with updating the guideline and making it more responsive to advances in clinical trial design and conduct. Multiple stakeholders then shared their experiences with ICH E6(R2). Overall, the web conference was a testament to the importance of having engagement at the heart of the development of E6.

View the slide decks for each day of the web conference to learn more from each presenter.

For additional information on the ICH E6 revision efforts, please refer to the following materials: