1. ICTMS Communicating Trial Results to participants
Amanda Hunn - May 2017

2. Health Research Authority (HRA)
Responsible for health research policy in England
Manage the research ethics committee system in England
Remit includes adult social care
Duty to promote transparency
Recently completed the EU guidelines for lay summaries of clinical trial results

3. Transparency – HRA approach
Transparency as a global issue
Pragmatic and proportionate approach to support UK competitiveness
Question on ethics application form since 2008
Registration of clinical trials requested from 2013
Deferral option for early phase trials
Guidance on information for participants at the end of a study

4. Guidance on information for participants at the end of a study
Information should include:
A thank you for taking part
What will happen to them at the end of a study including arrangements for treatment
How summary study findings can be accessed by participants
How those who would rather not see the findings can opt out of this process.
9 December, 2018

5. Guidance on information for participants at the end of a study
Other things to consider:
Which arm of study was I in?
Results at an individual level where appropriate
Invitation to take part in patient and public involvement
9 December, 2018

6. Guidance on information for participants at the end of a study
Information should be given to participants as their time in a study comes to a close
Applies to all interventional studies including clinical trials and diagnostic studies
Excludes Phase 1 studies of healthy volunteers
Does not require ethical review as long as it complies with the initial PIS
NB Guidance only
9 December, 2018

7. New EU Clinical Trial Regulation (EU No 536/2014)
Requirement for sponsors to place both a lay summary as well as a technical summary on the EU portal
The lay summary must be completed for normal clinical trials with 12 months of completion of the study and summaries for paediatric studies must be completed within 6 months
EC asked for a member state to volunteer to develop new guidelines on lay person summary of trial results”
UK volunteered to undertake this work in March 2015
Technical summary
Lay
summary
9 December, 2018

8. Who are EU lay summaries aimed at?
‘sponsors may provide trial results to investigators or third parties to feedback to patients who have taken part in their trials’
General Public
Study Participants
9 December, 2018

9. Involving patients in writing the summary
Good practice to involve patients in aspects of the research design:
- testing the PIS
assessing the burden placed on participants
considering the feasibility from a participant
perspective
contributing to design of PROMs
Why not involve them in writing/reviewing the lay summary?
9 December, 2018

10. Thank you Acknowledgement to CONDUCT-II Hub for Trials Methodology Research funding.
9 December, 2018