Project to develop International Consensus Guidance on the Inclusion of Pathology in Clinical Trial Protocols: The SPIRIT-Path Extension

The SPIRIT initiative aims to help improve the completeness and quality of trial protocols. The evidence-based SPIRIT recommendations were developed using systematic, transparent methodology and broad consultation with 115 experts representing diverse stakeholders involved in the design, funding, conduct, review, and publication of trial protocols.

» Read more about the SPRIT Statement here

The importance of pathology is increasingly being recognised in drug development and conducting clinical trials, from ensuring the correct diagnosis for selecting patients for targeted therapy, platform studies and endpoint validation of pathological complete response.

We therefore feel that an extension to the SPIRIT statement for Pathology will:

  1. Lead to more comprehensive clinical trial protocols
  2. Enhance clinical trial design and drug development through early pathology input
  3. Increase the number and availability of trials-active pathologists by raising the profile of pathologists in clinical trials
We have set up a steering committee in order to develop international, consensus-based, Pathology-specific protocol guidance in the form of an extension to the SPIRIT statement, a SPIRIT-Path extension.
Phase 1: a systematic review of existing Pathological-specific protocol guidance to generate an exhaustive long-list of candidate Pathological-specific protocol items;

Phase 2: refinements to the long-list and removal of duplicate items

Phase 3: an international stakeholder survey;

Phase 4:  an international Delphi survey

Phase 5: an international consensus meeting

SPIRIT-Path Steering Group

Member Role/Area Institution
Dr Tim Kendall SPIRIT-Path Co-Chair, CM-Path WS2 Member (Clinical Trials) / Pathological Society of Great Britain and Ireland Representative University of Edinburgh
Dr Max Robinson SPIRIT-Path Co-Chair, CM-Path WS2 Member (Clinical Trials) Newcastle University
Dr Abeer Shaaban CM-Path WS2 Member (Clinical Trials) Queen Elizabeth Hospital, Birmingham
Dr Owen Driskell CM-Path WS2 Member (Clinical Trials) NIHR
Dr Dan O’Connor CM-Path WS2 Member (Clinical Trials) MHRA
Dr Nick West CM-Path WS1 Member (Skills and Capacity) University of Leeds
Dr Maggie Cheang CM-Path WS3 Member (Discovery) Institute of Cancer Research
Prof Keith Hunter CM-Path WS3 Member (Discovery) University of Sheffield
Prof Clare Verrill CM-Path WS4 Chair (Technology and Informatics) University of Oxford
Miss Helen Pitman CM-Path Programme Manager, NCRI Strategic Support NCRI
Prof David Roberts RCPath Representative University of Oxford
Dr An-Wen Chan SPIRIT Representative Women’s College Research Institute,
University of Toronto, Canada
Dr José Palacios Calvo European Society of Pathology Representative Hospital Universitario Ramón y Cajal
TBC Trainee Representative
Emma Kinloch Consumer representative Consumer Lead, NCRI
Daniel Brierley Delphi Advisor University of Sheffield
Gary Middleton Clinical Advisor University of Birmingham

If you are interested in contributing, please register your interest here: