We aim to develop an international consensus-driven guidance on patient-reported outcomes (PROs) Core Outcome Set (COS) for dose-finding oncology trials with key international stakeholders (including trialists, regulators, patient partners, ethicists, PRO methodologists and funders). This core outcome set for PROS in dose-finding oncology trials will be a consensus-derived minimum, essential and consistent set of PROs that encourages researchers to assess treatment tolerability in dose-finding trials across all cancer types.
ContributorsProfessor Christina Yap (Principal Investigator), The Institute of Cancer Research;
Professor Melanie Calvert, University of Birmingham
Dr Devin Peipert, Northwestern University Feinberg School of Medicine,
Professor Lesley Seymour, Queen's University
Dr Anna Minchom, Royal Marsden Hospital and The Institute of Cancer Research;
Professor Paula Williamson, University of Liverpool
Disease Category: Cancer
Disease Name:
Age Range: 16
Sex: Either
Nature of Intervention: Any
- Charities
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Ethicists
- Journal editors
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Regulatory agency representatives
- Researchers
- Service users
- Statisticians
- COS for clinical trials or clinical research
- Consensus conference
- Consensus meeting
- Delphi process
- Focus group(s)
- Literature review
- Semi structured discussion
- Systematic review
This guideline development will utilise gold-standard methods for evidence-based COS development as recommended by the COMET Handbook, including:
o Conducting a systematic review and generating PRO candidate items from:
(i) PRO measures (e.g., PRO-CTCAE) used in previous dose-finding oncology trials and peer-reviewed published trial
papers,
(ii) PRO recommendations in dose-finding oncology trials and later phase oncology trials
(iii) Recommendations from key experts and patient partners.
o Prioritising identified PRO candidate items using a Delphi study with key stakeholders (clinicians, statisticians, trial managers, PRO methodologists, ethics committee, regulators, funders, journal editors, and patient partners), with opportunity to suggest additional PRO items
o Finalising core outcome set of PROs in dose-finding oncology trials via an international consensus meeting.