Patient Group Engagement

CTTI Launches New Case Study Resource to Help Drive Better, More Efficient Clinical Trials

Posted on by Hannah Faulkner

Building better clinical trials would be easier if organizations shared the practices that helped them successfully overcome obstacles. CTTI’s new resource, Building Better Clinical Trials: A Case Study Exchange, provides users with easy access to participating organizations to request more information and/or share information with others (via email, LinkedIn, or share icons) for open, honest information exchanges that can improve collaboration and increase the efficiency of clinical trials.

The site features case studies from more than 30 organizations that have applied CTTI’s recommendations and tools to improve clinical trials. These experiences provide helpful information on organizational challenges, opportunities, actions taken, the impact, lessons learned, and advice for others.

One case study that features Horizon Therapeutics’ experience using CTTI’s Patient Group Engagement (PGE) recommendations demonstrates how having access to the right resource can improve many aspects of clinical trial conduction. Jeffrey W. Sherman, Horizon’s Executive Vice President, Chief Medical Officer states, “Having the right tools at the right time can make or break a clinical trial. The Building Better Clinical Trials Case Study Exchange will not only make it easier for stakeholders to locate recommendations, resources, and solutions, but it will help them understand how these tools were successfully implemented by other organizations so they can sidestep potential roadblocks and streamline their clinical trials.”

By making these collective best practices and innovative solutions widely available, CTTI’s case study resource provides a forum that facilitates the exchange of ideas to create a clinical trial ecosystem that is more agile and adaptable. As Sonja Cloosterman, Principal Consultant Personalized Healthcare and Medical Affairs at Orikami put it, “The Case Study Exchange not only helps people find practical, actionable resources, but it serves as a way to generate an open flow of information that fosters greater collaboration and has the power to generate a global exchange of ideas within the larger clinical trials landscape.”

The hope is that sharing these lessons and experiences will lead to the creation of more efficient, streamlined trials.

Want to be featured on Building Better Clinical Trials: A Case Study Exchange?

Currently, the site features over 30 case studies, but more are being added regularly. If you are part of an organization that has used one of CTTI’s recommendations or tools and would like to be featured on the site, we may be able to include your story.

By sharing your experience, you can showcase your organization’s success while providing helpful information that will benefit other organizations and facilitate collaboration and knowledge sharing across the research community.

Please reach out to Karisa Merrill today to learn more.

CTTI Paper Features Tool to Help Sponsors and Patient Groups Identify Mutually Beneficial Opportunities for Collaboration

Posted on by Hannah Faulkner

Effective engagement between patient groups and research sponsors can enhance the quality and efficiency of clinical trials, improve patient recruitment and retention, reduce costs, and speed the pathway toward new medical treatments. One opportunity for sponsors is to identify and prioritize new effective engagement activities. A new manuscript in Therapeutic Innovation & Regulatory Science details CTTI’s evidence-based prioritization tool to help sponsors and patient groups pinpoint mutually beneficial engagement activities.

The web-based tool provides 24 unique engagement activities that span the medical product development lifecycle. Using a three-step decision-making process, the tool helps sponsors and patient groups define the expectations, goals, and important roles that will have the biggest impact on the design, conduct, and dissemination of clinical research. The findings help teams apply CTTI’s recommendations for effective patient group engagement by supplying the results in an easy-to-use visual priority matrix grid.

Read the full manuscript.

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.

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!

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.

Watch CTTI-hosted Webinar on FDA’s Patient Engagement Initiatives

Posted on by Hannah Faulkner

The FDA’s large portfolio of activities to integrate patient engagement throughout the agency was highlighted during a recent CTTI-hosted webinar, now available to watch online. “Patient Engagement in Action: Insights from Patients & the FDA” was held Thurs., Nov. 21, and featured:

  • Andrea Furia-Helms, OC, FDA
  • Michelle Tarver, CDRH, FDA
  • Robyn Bent, CDER, FDA
  • Diane Maloney, CBER, FDA
  • Theresa Strong, Foundation for Prader-Willi Research

“Patients are at the heart of all FDA activities,” Furia-Helms said. She kicked off the webinar with an overview of the history of patient engagement at the FDA. Participants then reviewed patient engagement activities throughout the process of development and regulatory decision-making for drugs, biologics, and devices.

Bent said that patients are uniquely positioned to inform understanding of the therapeutic context for drug development and evaluation. She added that there is a need for more systematic ways of gathering patient perspectives on their conditions and treatment options.

Strong spoke from the perspective of a patient advocate working with the FDA. She said that the patient perspective, particularly with rare diseases, provides context and nuance to the associated symptoms and challenges within a disease. “We bring some experience about living with the disorder and can hopefully help FDA staff understand that laundry list of symptoms, and tease out what is important to patients and what is keeping people living with Prader-Willi syndrome from living healthy and productive lives.”

CTTI and the FDA have partnered on several patient engagement efforts, including co-creating the Patient Engagement Collaborative (PEC) and collaborating on a recent “Enhancing the Incorporation of Patient Perspectives in Clinical Trials” workshop. Additionally, CTTI has developed a robust set of recommendations and resources that help foster effective patient group engagement.

Additionally, answers to the virtual Q&A session are available here.

FDA Patient Engagement Efforts Highlighted in CTTI-hosted Webinar

Posted on by Hannah Faulkner

Are you curious about what the FDA is doing to integrate patient engagement throughout the agency? Wondering how CTTI is collaborating on some of these efforts? Learn about a variety of initiatives during a CTTI-hosted webinar Thurs., Nov. 21, from 12:00 – 1:00 p.m. ET.

Confirmed speakers for “Patient Engagement in Action: Insights from Patients & the FDA” include:

  • Michelle Tarver, CDRH, FDA
  • Robyn Bent, CDER, FDA
  • Diane Maloney, CBER, FDA
  • Andrea Furia-Helms, OC, FDA
  • Theresa Strong, Foundation for Prader-Willi Research

Participants will discuss ongoing and planned patient engagement initiatives and the anticipated impact of these efforts on patients and clinical research.

Add the webinar to your calendar today.