Currently, there is no method to measure the patient experience in clinical trials, and Sponsor companies do not have available to them any examples or models for translating patient engagement into actionable insights that could help improve clinical trial design and trial execution ultimately to achieve a better patient experience. The Patient Experience Initiative is in the process of developing tools for clinical teams to engage patients in the study design and execution stages of clinical trials and increase the patient centricity of study programs. Ultimately, these tools will enable greater patient engagement and partnership with sponsors to design and execute clinical protocols that create better patient experiences in clinical trials.
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
The following assets will be delivered by this Initiative:
Patient Protocol Engagement Toolkit (PPET): Toolkit for sponsor study teams to facilitate discussions with patient advisory group participants through the capture and incorporation of patient insights to optimize clinical protocols during the study design phase.
Patient Experience Questionnaire Toolkit (PEQ): Toolkit for sponsor study teams to gain clinical trial participants’ feedback on their trial experience during the study conduct phase.
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.
The TransCelerate eLabels initiative will help the industry progress on the journey to digitally supported, patient-centric clinical supply chains.
The eConsent Initiative will create a common approach for the electronic consenting of patients using an array of digital elements and process efficiencies to increase insight into patients’ understanding, increase regulatory compliance, and reduce quality risks.