Communicating trial results to participants: the experience of the MRC Clinical Trials Unit at UCL Annabelle South MRC Clinical Trials Unit at UCL Good afternoon. It’s great to get a chance to explore this very important and difficult topic. I’m going to briefly give you a few examples of how different trials run by the MRC Clinical Trials Unit at UCL have approached this issue, before drawing out some of the challenges faced and the lessons learned. The MRC Clinical Trials Unit at UCL runs mostly Phase III clinical trials on: Cancer Infectious diseases (including HIV and TB) We work in 80 countries worldwide. 8 May 2017, ICMTC / SCT

ARROW: treating children with HIV in Africa Let’s start with an example from the one of our African trials: the ARROW trial, which was looking at how best to treat children infected with HIV. In ARROW, the main way of communicating results to participants was via meetings, which participants and their carers were invited to. These meetings weren’t dry academic affairs (that clearly wouldn’t be appropriate for the audience). They were more like celebrations of the trial. As well as investigators telling participants and their families of the results, the events also included cake, singing and dancing, and having fun. We’ve found that participant meetings are very popular with trial participants in Africa – they are a way of saying thank you to participants, and provide a safe space for children who may get very little opportunity to meet other young people living with HIV. The ARROW trial had a significant social science component within it. These results were communicated to participants via three graphic novels that explored some of the themes that came out of the social science. These were given to children who took part in the study, and also placed in clinic waiting rooms.

PROUD: HIV prevention in the UK Face-to-face meetings with participants in advance of the embargo lifting (under confidentiality agreement) Participant newsletter, distributed by email list study clinic teams both via individual emails and in paper form participant database where participants are asked to complete diaries Distributed link to results film via email and clinics Let’s look now at PROUD, whcih was a HIV prevention trial among men who have sex with men in the UK. In PROUD, the communication of results to participants started prior to the results being presented at a conference, via face-to-face meetings. Participants who attended the meetings were asked to sign confidentiality agreements. This approach allowed the researchers to get feedback on the results and messages prior to public presentation, so was a form of participant involvement rather than a one-way imparting of information. When the results were made public, a participant newsletter was distributed via a participant email list, sites (via email and printed copies), and electronically on the database website. The team also made a film about the results. This was distributed to participants via email and clinics. Participants were then involved in communicating the results of PROUD more widely.

STAMPEDE: prostate cancer in UK Multi-arm multi-stage trial: lots of results to communicate Printed summary distributed to sites for distribution to participants Series of roadshows around the country (including film of results) The final example I want to share is the STAMPEDE prostate cancer trial. STAMPEDE is a multi-arm multi-stage trial with around 9000 participants so far. The results of five comparisons have been released to date (with more coming next month). To communicate the results to participants we worked with the trial management group patient representatives to prepare a written summary. 7000 printed copies of this were sent to >100 STAMPEDE sites around the UK, who were asked to pass them on to participants. We also organised a series of events around the UK, in partnership CRUK, to give patients an update on the latest prostate cancer research, including STAMPEDE. STAMPEDE sites were asked to invite participants. We know from meeting STAMPEDE participants at the Roadshows that not every participant who wanted to hear the results received a printed summary. We don’t know how many participants were invited to the Roadshow – dependent on sites and investigators. Turnout was lower than hoped for, and relatively few were participants.

Challenges Cost May require specialist input not available within the trial team Unable to contact participants directly Getting sites, investigators and trial teams to take ownership of this issue Integrating communicating results into the trial process Mailing lists take time to build up Participants aren’t a homogeneous group Evaluating different approaches Cost – needs to be budgeted for May require specialist input not available within the trial team Unable to contact participants directly – dependent on sites Getting sites, investigators and trial teams to take ownership of this issue – sometimes seen as extra work Integrating communicating results into the trial process Mailing lists take time to build up Participants aren’t a homogeneous group – one size may not fit all (what, how, when), but tailoring introduces complexity, which has an impact on feasibility Evaluating different approaches – which is best? Something we haven’t really done yet, but on our list of things to do.

Lessons Plan and budget for this - don’t leave thinking about it until you’ve done your analysis Put in place systems during trial set-up, recruitment and follow-up that will help you communicate results Patient and public involvement is essential Offer participants a range of ways to find out results

Acknowledgements ARROW, STAMPEDE and PROUD trial teams ARROW social science team Patient representatives from these trials Cancer Research UK