Background: Clinical Trials Units are encouraged to integrate Patient and Public Involvement (PPI) into all aspects of trial design, running and oversight. This research explored the induction and training of PPI Contributors joining trial oversight committees and was used to update the Medical Research Council Clinical Trials Unit at University College London's (MRC CTU at UCL) induction pack for new PPI Contributors.
Methods: Published and unpublished materials provided by other CTUs and research organisations on training for PPI Contributors on oversight committees were reviewed, with themes then triangulated to identify the most common topics covered in induction training. A face-to-face workshop with PPI Contributors from the MRC CTU at UCL reviewed a draft updated Induction Pack. Findings from these discussions were incorporated into a revised induction pack which was then re-reviewed by the workshop attendees.
Results: No published literature on this subject was found. However, several common themes were identified from unpublished materials. Workshop attendees agreed with most of the themes suggested in the initial draft pack based on the literature search and also provided a number of additional topics for discussion.
Conclusions: There is very little consistency in the induction of PPI Contributors on oversight committees. Whilst most local guidance explains the general role of a PPI Contributor, more context and background of the particular trial needs to be provided to allow for adequate induction of new committee members. The Induction Pack created provides a framework upon which trial managers can build a full picture of their study.
Keywords: Clinical trials; Independent data monitoring committee; Induction; Oversight committee; Patient and Public Involvement; Trial management group; Trial steering committee.
Clinical Trials Units are encouraged to integrate Patient and Public Involvement (PPI) into all aspects of their trials. This research explored the induction and training of PPI Contributors (e.g. patients, carers and members of the public) joining trial oversight committees. These committees regularly review trial progress and ensure participant safety. PPI Contributors sit on the committees to provide important guidance and advice on what the trial is like for a participant taking part.We looked at existing materials and research to find out what is already in use and how useful PPI Contributors felt it may be. We also held a workshop with existing PPI Contributors who had experience of participating in trials and sitting on oversight committees to find out what information they felt would be useful during the induction of a new member.Our research was used to create an induction pack for new PPI Contributors at the Medical Research Council Clinical Trials Unit at University College London (MRC CTU at UCL). We have made this resource available to all researchers and in this report we describe how it was created.