TransCelerate - Patient Experience in Clinical Trials

Patient Experience

The Patient Experience (PE) Initiative seeks to facilitate and accelerate the industry’s progression towards a future where the patient experience is enhanced in clinical trials and patient burden is reduced.

Rationale

TransCelerate’s Patient Experience initiative tools are intended to provide more effective ways to engage with patients and caregivers in the design and execution of clinical studies.

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 Patient Protocol Engagement Toolkit (P-PET) facilitates the design of clinical studies with patient and caregiver inputs.

The Study Participant Feedback Questionnaire (SPFQ) Toolkit is a set of questionnaires administered at the beginning, during and end of the study to improve studies by learning from patients.

The Gratitude Toolkit (GRAT) offers best practices, customizable templates, and considerations to support study sponsors as they acknowledge the critical role that study participants play in the development of new treatments.

Benefits

Benefits for Patients:

Increased engagement through better communication and feedback processes
Increased understanding of the value in participating in clinical trials
Potential increase in the sense of altruism due to the confidence of knowing that their participation and feedback in trials may improve future study volunteers’ experiences
Potential decrease in the burden of participating in clinical trials

Benefits for Sponsors, Sites and Investigators:

Potential improvement in patient recruitment, retention, and adherence within clinical trials
Potential reduction in long term costs through more effective patient engagement

Implementation Experience

As solutions are used throughout the R&D ecosystem, TransCelerate receives feedback related to solution implementation experiences. Anyone can submit an experience through the Engage with Us page and in select cases, we share the experiences on Our Impact page in a blinded way. Below is a featured example for this initiative:

“Patient input leads to study design change reducing patient burden” – Featured Solution: Patient Protocol Engagement Toolkit (P-PET)

Available Solutions

Initiative Solutions

The following assets are now available:

Related Initiatives

Patient Technology

The Patient Technology (PT) Initiative seeks to facilitate and accelerate the industry’s progression towards a future where patients have access to innovative technologies that enhance the patient experience and reduce patient burden in clinical trials.

eLabels

The eLabels Initiative will support TransCelerate Member Companies in establishing an innovative information channel: Electronic Labels (eLabels). This initiative will work to enhance label utility for patients.

eConsent

The eConsent Initiative will create a common approach for the electronic consenting of patients using an array of digital elements and process efficiencies to provide insight into patients’ understanding, increase regulatory compliance, and reduce quality risks.