TRM-SLE project overview

The TRM-SLE project explained

The Treatment Response Measure for Systemic Lupus Erythematosus (TRM-SLE) project will develop a new clinical outcome assessment for SLE clinical trials that accurately measures treatment effects that are clinically meaningful to clinicians and patients and defeats the limitations of current clinical trial outcome measures.

To achieve this, we plan to:

  • Specifically design the TRM-SLE for the context of an SLE clinical trial.
  • Prospectively develop and validate the TRM-SLE according to modern instrument development guidance.
  • Incorporate input from all key stakeholder groups in the instrument development process.

The TRM-SLE Taskforce


TRM-SLE Monash Research Team L-R: Ms Sonia Purswani, Dr Raychel Barallon, Dr Laura Eades, Dr Kathryn Connelly, Ms Rachel Koelmeyer, Prof Eric Morand, A/Prof Vera Golder, A/Prof Rangi Kandane-Rathnayake. Current team members absent: A/Prof Darshini Ayton, Dr Lavanya Rajagopala, Dr Yanjie Hao and Dr Katie Liao

A global collaboration of more than 80 SLE clinician-scientists, patient representatives, industry partners, and regulatory and metrology experts was established in 2022 to develop the TRM-SLE.

The Taskforce consists of four governance committees with international representation:

  1. A Steering Committee responsible for delivery of the project.
  2. A Scientific Advisory Board providing expert scientific oversight.
  3. A Patient Advisory Panel comprising SLE patients and patient organisation representatives.
  4. An Industry Advisory Board overseeing regulatory affairs related to the project.

Monash University’s Professor Eric Morand is the chief investigator for the TRM-SLE project. He is supported by a team of Monash University clinician-scientists and research support staff to deliver the TRM-SLE instrument.

Project status

These project milestones have been achieved (see Publications for further details):

  • Preparation of a protocol for development of the TRM-SLE.
  • Definition of the high-level measurement goals for the TRM-SLE.
  • Completion of an international Delphi study to achieve consensus on the domains to include in the TRM-SLE.
  • Establishment of domain working groups to reach consensus on how each domain should be measured.
  • Attainment of consensus on how each domain should be measured.

Next stages of the TRM-SLE project

  • Attainment of consensus on how to integrate the various domain measures into an overall measure of treatment response.
  • Extensive validation of the TRM-SLE instrument in existing datasets and prospectively in future clinical trials and longitudinal SLE cohort studies.

Contact us

Please contact us for any TRM-SLE project enquiries.