Improving Patient Involvement in Cancer Clinical Trials: Development of Plain Language Checklists Within the SISAQOL-IMI Initiative
Author(s)
Silene ten Seldam, MSc1, Eilidh Mairi Duncan, PhD1, Katie Joyner, MA1, Kate Morgan, BA, MSc1, Cecilie Delphin Amdal, MD, PhD2, Kristin Bjordal, MD, PhD3, Vincent Claus, MA1, Solomon Alexis, MSc, MRes1, David Ness, BA1, Hans Scheurer, MA1, Madeline Pe, PhD4, Ahu Alanya, PhD4, Elektra Papadopoulos, MPH, MD5, Kate Sandberg, PhD5.
1Myeloma Patients Europe, Brussels, Belgium, 2Oslo University Hospital, Oslo, Norway, 3Oslo University Hospital, University of Oslo, Oslo, Norway, 4European Organisation for Research and Treatment of Cancer, Brussels, Belgium, 5AbbVie, Evanston, IL, USA.
1Myeloma Patients Europe, Brussels, Belgium, 2Oslo University Hospital, Oslo, Norway, 3Oslo University Hospital, University of Oslo, Oslo, Norway, 4European Organisation for Research and Treatment of Cancer, Brussels, Belgium, 5AbbVie, Evanston, IL, USA.
OBJECTIVES: Improving the standardisation and transparency of patient-reported outcome (PRO) analysis in cancer trials is essential to support patient-centred treatment, care and shared decision-making. The SISAQOL-IMI (Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints - Innovative Medicines Initiative) initiative aimed to establish robust guidance for the design, analysis, presentation, and interpretation of health-related quality of life (HRQoL) data in oncology. A core component of the initiative was the development of plain language checklists to enhance patient involvement in the design of clinical trial protocols as well as to support patient advocates in providing feedback on clinical trial quality of life results.
METHODS: A multi-stage development process was used, involving: 1. Review of existing guidance and support tools for patient involvement in clinical trials, 2. Prioritisation of SISAQOL-IMI recommendations from patient perspectives, 3. Drafting of initial plain language checklists aligned with key PRO design, analysis, interpretation, and reporting domains, 4. Consultation with multi-stakeholder working groups including patients, clinicians, researchers, regulators, HTA and industry representatives.
RESULTS: Three plain language checklists were developed: (1) review of cancer clinical trial protocols, (2) review of scientific visualisations, (3) review of plain language visualisations. Key protocol review checklist domains include general points on PRO-related rationale, objectives, and endpoints; evaluation of PRO time points; PRO score interpretation thresholds; and strategies for handling intercurrent events. Key visualisation review checklist features include examples of best-practice graphs that provide transparency on missing data and handling of intercurrent events. Stakeholders valued consistent language, contextual interpretation, and visual aids.
CONCLUSIONS: The SISAQOL-IMI plain language checklists offer a co-produced, evidence-informed resource to better support stakeholders, including patient advocates, in the design of clinical trial protocols and promote meaningful and consistent interpretation of cancer PRO findings. Integrating these tools within the broader implementation of the SISAQOL-IMI recommendations will ultimately support patient-centric decision-making in oncology.
METHODS: A multi-stage development process was used, involving: 1. Review of existing guidance and support tools for patient involvement in clinical trials, 2. Prioritisation of SISAQOL-IMI recommendations from patient perspectives, 3. Drafting of initial plain language checklists aligned with key PRO design, analysis, interpretation, and reporting domains, 4. Consultation with multi-stakeholder working groups including patients, clinicians, researchers, regulators, HTA and industry representatives.
RESULTS: Three plain language checklists were developed: (1) review of cancer clinical trial protocols, (2) review of scientific visualisations, (3) review of plain language visualisations. Key protocol review checklist domains include general points on PRO-related rationale, objectives, and endpoints; evaluation of PRO time points; PRO score interpretation thresholds; and strategies for handling intercurrent events. Key visualisation review checklist features include examples of best-practice graphs that provide transparency on missing data and handling of intercurrent events. Stakeholders valued consistent language, contextual interpretation, and visual aids.
CONCLUSIONS: The SISAQOL-IMI plain language checklists offer a co-produced, evidence-informed resource to better support stakeholders, including patient advocates, in the design of clinical trial protocols and promote meaningful and consistent interpretation of cancer PRO findings. Integrating these tools within the broader implementation of the SISAQOL-IMI recommendations will ultimately support patient-centric decision-making in oncology.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR135
Topic
Organizational Practices, Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation, Patient Engagement, Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology