Personalized Clinical Trials Framework
What is the Personalized Clinical Trials Framework?
Feedback from clinical trial participants demonstrates that they want options for their clinical trial experience. Participation in a clinical trial can be time intensive and burdensome, while being an important component of a participant’s healthcare experience. The goal of personalized clinical trials is to provide options, where possible, to enable participants to integrate the clinical trial requirements more seamlessly into their lives.
The interactive Personalized Clinical Trials Framework is a set of practical considerations to support the R&D ecosystem (i.e., sponsors, sites, third parties, and other clinical trial stakeholders) with understanding and evaluating options that enable a more personalized experience for clinical trial participants across diverse populations. The framework provides fourteen potential opportunities to enable personal choice into a clinical trial, and includes considerations to help action the opportunity, potential value and benefits, as well as tools and resources to support implementation.
When utilizing this framework, stakeholders should carefully consider each of the following:
- How each opportunity can be incorporated into your health literacy and participant engagement strategy
- The local laws, regulations, and cultural disparities that potentially impact the implementation of these opportunities
- Partnering early and seeking to understand the needs of participants / care partners / patient organizations / clinical sites and other relevant stakeholders to obtain input into study design, tools / tactics / material design, etc.
- One size does not fit all when considering clinical trial participants and their preferences or what tactics may be most valuable for a particular site, targeted indication, or therapeutic area
- Each opportunity has a stand-alone benefit and can be used independently, but to help maximize participation and access, consider and plan for multiple opportunities during study design, where possible
- These tools and resources are not an exhaustive list and may not cover all opportunities and options
The “Offering Choice to Patients” Webinar provides a high-level overview of TransCelerate’s Personalized Clinical Trials Framework, with insights into how to incorporate the Personalized Clinical Trials Framework as an integral part of clinical trials within your organization. Check out the webinar presentation and recording.
In addition to the Personalized Clinical Trials Framework, the Patient Experience initiative developed three toolkits to offer more effective ways to engage with patients in the design and execution of clinical studies. These tools aim to improve engagement and partnership between biopharmaceutical companies and patients to help create better experiences for clinical study participants.
Navigate to the Patient Experience Toolkits
Click below on the toolkit you would like to know more about.
Design clinical studies with patient inputs
Patient Protocol Engagement Toolkit
A clinical study engagement toolkit composed of:
- Sponsor-facing operational user guide*
- Resource guide* with question bank
- Templates to enable study sponsors to engage with patients during clinical study design
Gather patient feedback during clinical studies
Study Participant Feedback Questionnaire Toolkit
A clinical study participant feedback toolkit composed of:
- Socialization Presentation, which includes background information for initial Sponsor discussions
- Implementation user guide
- Set of 3 Study Participant Feedback Questionnaires (beginning, during, and end of study) and a Question Bank Addendum
Show appreciation to clinical study participants
A toolkit designed to enable study sponsors and sites to show appreciation to clinical study participants. It is composed of the following:
- Implementation User Guide
- Customizable templates
Check out how we developed the P-PET and SPFQ Toolkits: