1. 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

2. 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.

3. 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
list
study clinic teams both via individual s and in paper form
participant database where participants are asked to complete diaries
Distributed link to results film via 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 list, sites (via and printed copies), and electronically on the database website. The team also made a film about the results. This was distributed to participants via and clinics.
Participants were then involved in communicating the results of PROUD more widely.

4. 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 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.

5. 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.

6. 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

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