Reflections on Patients as Partners Europe 2019
My five key takeaways from this year’s conference.
The third annual Patients as Partners Europe conference took place in London on 28th and 29th January 2019. The conference brought together patients, patient organisations and industry to share best practice examples of patient involvement in research, and to discuss some of the challenges for all stakeholders as we strive towards integrating involvement as a routine part of the research & development process (R&D).
Here are my five key takeaways from the event.
1. There is lots of great stuff happening — we need to get better at sharing it
It was really encouraging to see so many great examples of pharma working in true partnership with people affected by health conditions to improve research.
However, it was clear that we need to get better at sharing the work we are doing so others can learn from it. This echoes an ask I have heard at a number of meetings over the past year — to have more case studies available that clearly demonstrate the impact of patient involvement, and the benefits of industry and patient organisations working together. I think it’s also really important that these case studies capture the challenges and learnings from partnerships too, so we can use these to improve collaborative working in the future.
There are actually already some great case studies out there — they’re just not very easy to find. The EUPATI toolbox contains over 25 (from what I could see) case studies of patient involvement, with all reports following a standard format which includes a description of the activity, benefits, challenges and learnings. These are all tagged under the search term ‘Patients Involved’ on the website.
On day 2 of the conference, Luther Clark from MSD called on all attendees to play their role in building the portfolio of examples of partnerships. It would be great to see all presenters commit to writing up their work as a case study to be shared on an accessible platform, such as EUPATI, so others can learn from their experiences.
2. Patient involvement needs to be strategically embedded into the drug development process
If organisations want patient involvement to be truly transformational, it needs to be part of their strategic plan for R&D. Berkeley Phillips described how Pfizer have been striving to embed patient involvement throughout all stages of their drug development processes, an aspiration that is supported by those at the very top of the organisation. He emphasised the importance of organisational leadership in ensuring that patient involvement is “hardwired into end-to-end processes” for developing a medicine.
Crucially, patient involvement should not be limited to feedback on clinical trial protocols and patient information sheets. Vanessa Pott from Merck commented:
“There is no point along the drug development continuum where the patient voice does not add value.”
Maria Piggins, EUPATI graduate and Patient Advocate, added:
“We need to look at this as reciprocal relationships, not one off transactions at individual points along the R&D lifecycle.”
I am keen to see more dialogue at the non-clinical development stage — in between identifying unmet needs and clinical development. For example, involving people affected by health conditions in discussions about which molecules to take forward for further testing, or consulting them on the best delivery methods for a drug, or safety aspects. These are all important questions, and those receiving treatments have a right to the opportunity to be involved in this stage of decision-making.
3. More needs to be done to support meaningful patient involvement within CROs
Many clinical studies are outsourced to contract research organisations (CROs) — independent companies that organise and carry out clinical trials to test new medicines. As key stakeholders in the research and development process, it is crucial that CROs are also embedding patient involvement in their work. However, the nature of their relationship with industry can make it particularly challenging for CROs to do this effectively and meaningfully.
Joyce Moore (ICON) and Rosamund Round (PAREXEL) highlighted some of the challenges CROs face, including tight deadlines, a lack of communication from pharma companies about how they have already involved patients in the process, and the difficulty of changing attitudes towards involvement within CROs.
The discussion highlighted the need for industry to do more to support CROs to effectively involve patients, and the need for patient organisations to work with CROs more closely to identify suitable opportunities for involvement. And this involvement needs to move beyond improving trial recruitment and retention — yes this is important, but reaching your recruitment target for a trial that has no meaningful endpoints for patients is not a win for anyone — not least the participants. As Elaine Sutcliffe (Patient Advocate) pointed out on day 2 of the conference, when people invest time in a one trial, they are giving up the chance to participate in others. It is vital that we design the best studies possible to ensure that people’s time is not wasted. And to do this, we need to involve patients.
“I can’t imagine that the best research can be designed without meeting people affected by the condition.”
Elaine Sutcliffe
4. Compliance and contracts are a big barrier to working together — training for legal teams is needed
A recurring theme throughout the conference was the persistent difficulty faced when it comes to the legal stuff.
Compliance is a foreign concept for patient organisations, and the process of getting approval can lead to delays in projects which is frustrating. Contracts and agreements are often full of jargon and inappropriate for the nature of the partnership. Most patient organisations don’t have a legal team to deal with these issues, which can mean that organisations and individuals are entering into agreements that they don’t fully understand. Even when they do have legal support, it can take months of back and forth discussions to revise agreements to make them suitable, again leading to delays.
On day 2 of the conference, Kate Trenam (UCB), Elaine Sutcliffe (Patient Advocate) and myself discussed our solutions to some of these challenges. Good communication is key, and there needs to be understanding and recognition of the different ways of working for each organisation. Bringing legal teams into the conversation much earlier means that differences in opinion can be identified from the outset and negotiation can begin sooner.
Importantly, legal teams need to be educated on patient involvement so they have a clear understanding of how pharma and patient organisations want to work together. Training for pharma legal teams would be hugely beneficial. It would be great to see industry work together to develop some training that could be used across organisations to ensure consistency in messaging.
5. Educating other colleagues within pharma on patient involvement is important — and helps inspire
The conference was a great opportunity to share practical examples, openly discuss challenges and think about what more can be done to increase patient involvement in R&D.
It’s important to remember, though, that the people in the room at this kind of conference are (most likely) the champions for involvement in their organisations. As several speakers noted — “we’re preaching to the choir here”. It is therefore crucial that we share our experiences and knowledge with colleagues, and educate them on the importance of involving patients.
On day 1 of the conference, Liz Clarke (Norgine), Jim (Patient) and Lucy (Partner) spoke about the success of Norgine’s inaugural patient day, where patients and their partners visited the Norgine office and met with employees across all areas of the organisation. Jim and Lucy valued the opportunity to meet with staff, and commented on the mutual benefit for everyone involved. Staff found the day inspiring, and afterwards many reported feeling an increased sense of purpose in their work.
Integrating patient involvement into R&D processes requires cultural change within organisations. As James Duhig (AbbVie) put it — “it has to be everybody’s job”. Engaging staff and educating them on the importance of involvement is key to achieving this cultural change, and this requires other colleagues to step up and champion involvement within their organisation.
There’s lots to be done this year!
Patients as Partners was a great way to start the conversations around patient involvement in 2019. And it’s great to see how the conversation has progressed over the last few years — the question is no longer “why should we it?” but “how do we do it?”, and we are moving away from “proving” towards “improving”.
We’re moving in the right direction, but there is still lots more to be done. What action can you take within your organisation to move this forward?
