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PCS for Clinical Trials

This page contains a number of resources for those wishing to use PCS in clinical trials.

The content is intended for guidance only. If you have any recommendations for the content on this page please let us know at contact@pcsig.org

Proceedings from PCSIG Workshop -Incorporating Patient Centric Sampling into Multicentre Clinical Trials

This document describes the output from the workshop held at Roche's facilities in Welwyn Garden City, UK on 11 and 12 June 2024 attended by 48 individuals representing pharmaceutical and biotech companies, contract research organisations, technology and solutions vendors, academia, publishing and consultants.

The report content includes discussion around a number of challenges encountered when incorporating PCS into clinical trials and suggestions on how to overcome these and potential future activities.

Check-list: Integrating Patient Perspectives into Clinical Trials Incorporating PCS

This document outlines a number of considerations to ensure that the voice of the patient is central when designing and performing clinical trials, particularly when a PCS aspect is included. Use this document as an essential part of designing and running clinical trials and adapting to rising patient needs.

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FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making

Incorporating Patient Centric Sampling into Multicentre Clinical Trials -
Protocol Template Text

This document gives suggested template text for incorporation into study protocol documents when PCS is incorporated into clinical trials.

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Incorporating Patient Centric Sampling into Multicentre Clinical Trials -
Lab Manual Template Text

This document gives suggested template text for incorporation into study lab manual documents when PCS is incorporated into clinical trials.

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