ePRIME - patient-reported AEs in early phase trials: phase 1

• Research type

  Research Study

• Full title

  electronic Patient self-Reported outcomes to Improve cancer Management and patient Experiences (ePRIME) - collection of patient-reported adverse events (AEs) in Early Phase Clinical Trials in Yorkshire: phase 1 interviews

• IRAS ID

  212262

• Contact name

  Galina Velikova

• Contact email

  g.velikova@leeds.ac.uk

• Duration of Study in the UK

  0 years, 7 months, 0 days

• Research summary

  ePRIME - patient-reported symptoms in early phase trials: phase 1
  New treatments are continually being developed to help patients living with advanced cancer, and these require extensive clinical trials before authorisation for standard clinical use. Reporting of adverse events (AE) is essential to ensure treatment safety and tolerability. The current system for reporting AEs, the Common Toxicity Criteria and Adverse Events (CTCAE) relies on the clinician’s interpretation of patient symptoms, but evidence suggests clinicians miss/underestimate AEs experienced by patients. The added value of patient self-reports of AEs is recognised, but is rare in early phase clinical trials (EPCT). Electronic methods provide an innovative way of capturing this information. This project is part of a programme of work funded by Yorkshire Cancer Research to explore innovative methods of using electronic patient reported outcomes (ePROs) to support cancer patients.

  Our overall aim is to explore the implementation of an ePRO-trial system (electronic linkage/integration with a clinical trial database) in an EPCT. The project involves two phases, firstly a preparatory qualitative phase and then a pilot study. This protocol relates to the first phase, which aims to:
  • explore patients, clinicians and trial staff views of dealing with AEs in clinical trials and patient-reported AE reporting in EPCT
  • explore the feasibility of introducing PRO-AEs in EPCT in terms of practical and ethical issues

  We aim to recruit a diverse sample of around 30 participants including EPCT patients (age, gender, phase/type of trial), clinicians, trial staff and individuals from regulatory bodies (length of time involved with EPCT). We will explore their views on the issues surrounding AE reporting in EPCT and implementing ePROs in this setting. The interviews will be transcribed and analysed qualitatively to identify emergent themes, informing the development and implementation of PRO-AE reporting in a subsequent pilot study involving EPCT patients.

• REC name

  North West - Greater Manchester West Research Ethics Committee

• REC reference

  16/NW/0659

• Date of REC Opinion

  5 Sep 2016

• REC opinion

  Favourable Opinion