Patient Experience

May 7, 2025

Patient Protocol Engagement Toolkit Enabled Delivery of Successful Patient-centric Advisory Board

Featured Solution: Patient Protocol Engagement Toolkit (PPET) One member company leveraged the Patient Protocol Engagement Toolkit from TransCelerate as guidance for their first Patient Advisory Board (PAB) which was co-facilitated with an international patient organization. The member company identified the need for early patient input in the clinical development program. The aim was to engage…

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April 19, 2024

Partnering with Sites to Provide a More Inclusive Environment for All

Featured Solution: Sponsor Toolkit Site Engagement and Capacity Building Considerations for Diversity, Equity and Inclusion of Participants in Clinical Trials (DEICT) In an effort to increase diverse participant enrollment through better partnerships with sites, a sponsor found a different and innovative way to support choice sites. The sponsor saw an opportunity to support its sites…

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February 23, 2024

O-CAT Helps Study Team Package Key Endpoints to Reduce Patient Burden

Featured Solution: Operational Complexity Assessment Tool (O-CAT) For one clinical trial sponsor, patient experience is key to decision-making for clinical trial design and operationalization. They are focused on engaging research participants as partners and providing them with options. Decentralized clinical trial (DCT) elements provide patient flexibility. However, they are not widely used in all therapeutic…

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November 8, 2023

Expressing Gratitude and Transparency: The Impact of Thank You Letters in Early-Terminated Studies

Featured Solution: Clinical Research Access & Information Exchange “We do not force teams to use thank you letters, but they are often implemented by study teams. The survey respondent has used these letters in a number of studies that were terminated early (most recently in Huntington’s disease) to thank participants for their contributions and explain…

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November 8, 2023

Improved Study Protocol Design for a Rare Disease through Patient and Caregiver Interviews

Featured Solution: Patient Protocol Engagement Toolkit (P-PET) Background A sponsor company used parts of the Patient Protocol Engagement Toolkit (P-PET) for patient and caregiver (patient’s mother) interviews to obtain patient insights for a recent study protocol. The interviews were conducted virtually. The interview slide deck was developed with reference to the P-PET toolkit, and some…

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November 8, 2023

Successfully Measured Participant Satisfaction in a Phase I Trial

Featured Solution: Study Participant Feedback Questionnaire (SPFQ) “Within our member company, we had an objective to advance patient-centricity in our trials, but nothing was readily at hand to use within current trials. Our clinical operations office pivoted toward TransCelerate’s Study Participant Feedback Questionnaire (SPFQ) because the solution gave us a strong starting point; we did…

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November 8, 2023

The Patients Have Spoken: 75% of Participants Completed a Satisfaction Survey Modeled After the SPFQ in a Decentralized Clinical Trial  

Featured Solution:  Study Participant Feedback Questionnaire During the Covid-19 pandemic, a clinical trial in Canada deployed a survey modeled after the SPFQ created by the Patient Experience Initiative. Below are two excerpts regarding how this clinical study used its survey to understand participants’ feedback about some aspects of a decentralized trial. Overall, participants had positive…

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May 25, 2023

Better Understanding Technology Use to Achieve Patient-centric Objectives

Featured Solution: Patient Technology Implementation Framework “The Clinical Innovation (CI) team within our company is responsible for the implementation of digital patient-facing technologies (DPFT) in the clinical studies. CI worked closely with two study teams who were interested in leveraging DPFTs. CI utilized the patient technology implementation framework as a roadmap to avoid redundancy while…

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May 25, 2023

Patient input leads to study design change reducing patient burden

Featured Solution: Patient Protocol Engagement Toolkit (P-PET) “As part of our feasibility processes for a large breast cancer oncology clinical program, our study teams used parts (elements) of the ‘P-PET toolkit‘ to engage with patient advisory groups (patients, survivors, and co-survivors) about a number of planned clinical trial designs. Early draft study protocols (prior to…

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July 15, 2020

Layperson Summaries

Provides general priniciples helping sponsors prepare and distribute layperson summaries to the general public and study participants to implement the obligations of the European Union Clinical Trial Regulation No. 536/2014.

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