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.

SPFQ Question Bank Submission Form – Live through July 15, 2022

Are you a patient/caregiver or member of a biopharmaceutical company, academic institution or research organization motivated to create better experiences for clinical study participants, caregivers, and families?

Do you have questions or topics that you feel are important to include in TransCelerate’s Study Participant Feedback Questionnaire (SPFQ)? Have you modified the current version of the SPFQ to meet your needs? If so, TransCelerate would love to hear from you! Submit your topics or questions by taking this quick survey. Click here to review the current version of the SPFQ.

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 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.

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

Available Solutions

Initiative Solutions

The following assets are now available:

Patient Protocol Engagement Toolkit (P-PET):The P-PET provides tools and resources to use in engaging patient advisors and caregivers during protocol development with the goal to improve patient experience and reduce patient burden as a study participant. The P-PET can be utilized by sponsors to partner with patient advisors and caregivers in creating patient-centric clinical studies. The toolkit was updated in 2021 and again in 2022 to include new considerations for caregivers, best practices for engaging patients in a virtual environment, and guidance for Key Performance Indicators (KPI).

Study Participant Feedback Questionnaire Toolkit (SPFQ): The SPFQ is a questionnaire for patients at the beginning, middle and end of a clinical study. The questionnaire results will help sponsors learn from patients so that they may improve trials.

Similar 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.