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.

SURVEY LIVE – Nov 1, 2021 – Jan 31, 2022

Help TransCelerate understand your experience implementing solutions & tools aimed to improve the patient experience in clinical research. Do you work for an organization that plays a role in the design and execution of Clinical Trials such as Clinical Research Organizations, Biopharmaceutical Companies (that are not members of TransCelerate), Clinical Research Sites, Clinical Research Technology Providers, and Research Institutions (Academia)? If so, TransCelerate wants to hear from you by taking this survey! Click here to view survey details including solutions asked about in survey.

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 due to the shifting environment posed by COVID-19. New considerations for caregivers and best practices for engaging patients in a virtual environment have been added.

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.