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.

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!

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.

As part of its commitment to promote the engagement of patients as equal partners in clinical research, CTTI launched a new tool today at the 2019 DIA Global Annual Meeting that will help sponsors and patient groups identify high-value opportunities to collaborate.

The free web-based tool walks users through a three-step prioritization process:

1. Identify relevant engagement activities. Patient groups and sponsors first identify all potential opportunities to collaborate, working from a comprehensive list developed by CTTI and adding their own fit-for-purpose activities.
2. Evaluate benefits and investments. After reviewing factors identified by CTTI research, sponsors and patient groups rate the benefit and investment of each activity.
3. Identify mutually beneficial activities. Research sponsors and patient groups compare and discuss their respective priorities and decide on opportunities that are of high value for each. A benefit/investment matrix helps visualize priorities and support discussion.

The tool is part of CTTI’s Patient Groups & Clinical Trials work, which encourages sponsors, investigators, and other stakeholders to engage with patient groups early and often for better and more efficient clinical trials.

“This new prioritization tool builds on the foundational work CTTI has already completed and ensures that collaboration is focused on areas where the greatest benefit can be achieved for everyone involved, given limited resources,” said CTTI Executive Director Pamela Tenaerts. “With an easy, three-step process, the tool helps create and identify high-value opportunities for patients and sponsors to engage in the clinical research enterprise.”

Linda Brennan, director of community partnerships at the Cystic Fibrosis Foundation, and Jaye Bea Smalley, director of patient advocacy and life cycle management for inflammation and immunology at Celgene Corporation, will publicly introduce the tool in the “Identifying High-Value Patient Engagement Opportunities: A Collaborative Three-Step Process for Sponsors and Patient Groups” DIA 2019 session at 8 a.m. PT.