Patient Engagement. It means different things to different people. Until recently, the term was mostly used by corporations as a euphemism for brand loyalty to their medical products, or by healthcare providers as the antidote to "noncompliance." We at the 'Mine think of engagement not so much as what others convince us to do, but as a chance for patients to take the reigns, acting as catalysts for change themselves. That's what the DiabetesMine Innovation Project is all about, and we're happy to see this view spreading.
I was fortunate to be among 10 diabetes advocates attending a one-day conference in Washington D.C. last week hosted by Sanofi's Partners In Patient Health program, honing in on how patients can take a bigger role in the medical innovation process -- this case via research and development or involvement in various aspects of clinical trials.
Partners in Patient Health is a coalition of patient advocacy groups Sanofi founded last year to "transition from advocacy sponsorships to true partnerships" with these organizations. The Diabetes Hands Foundation, diaTribe, DCAF and DiabetesMine are a few of the diabetes-specific members of this cross-disease coalition.
The summit they held on Oct. 23 was the second such event bringing together Sanofi execs with patient advocates, government and regulatory officials, and representatives from national advocacy organizations and others in the healthcare world. There were about 80 people in attendance, and it was a full day of panel discussions and other sessions on how to get people with diabetes (PWDs) more involved in official processes that affect them.
For me, the big takeaway was seeing how large a communication gap actually exists between us PWDs and the research community, and also healthcare professionals of all types who are often the ones right there in the trenches where patients meet doctors and researchers.
Case in point: Lowering my A1C by a quarter of a percentage point isn't motivation enough for me to get involved in a clinical study, especially one that may last for two or more years and in which I may not ever see any progress report or update on what that research found. If we're talking about a new medication or treatment that could take a decade or more to hit market, it's even less appealing to me personally to take the time and effort to join a study. And it's especially unlikely if my doctor doesn't even know about particular research, or understand it well enough to see any need to point me towards getting engaged.
What I came away with was: Those doing early R&D aren't talking our language and getting the message across about why we should care. And if we should to know and care about a certain studies, the dots mostly aren't being connected so that we know how to get involved. All of this means not enough PWDs are engaged in the early medical innovation process -- and of those who aren't online or actively involved in advocacy are even less likely to learn about this or be able to participate.
Trains of Thought
You can still review the play-by-play twitter stream from the summit by searching the hashtag #diabetesPIPH.
As noted, there were about 10 DOC (diabetes online community) advocates there -- Brandy Barnes, Ann Bartlett, Kelly Close, Adam Brown, Bennet Dunlap, David Edelman, Christina Roth, Cherise Shockley, and Kerri Sparling. Others included leaders in different disease states, and research and pharma experts; I know at least one biopharm industry leader present has also been type 1 for most of her life.
We were stationed at tables around the room, each identified by the name of some on-the-horizon diabetes innovation. I was at the "Smart Glucose Sensors" table (very fitting since I had my new Dexcom G4 with me!). Next to us was the "Artificial Pancreas" table, and not too far was the "Inhaled Insulin" table. Although we were sitting among various people from the industry, we unfortunately didn't get any juicy insights into when all this stuff is coming; but they were fun table titles, nonetheless.
Many of us PWDs seemed to have similar trains of thought and messages to share: talk our language, reach out to us earlier in the process rather than later, make sure you're telling us what this realistically means to us and our lives, and please be clear about how we can get information out to others who might want to access it. There was also quite a bit of discussion about removing stigmas from diabetes, and making sure we're being talked with, not to.
All of these themes have been echoed in other places for years, but continue to need more attention within the D-Community. So that was a value of this summit.
Of course, the results of clinical trials are focused on the "medical benefit" for PWDs, mostly measured by A1C impact. That is what clinical trial data focuses on, the medical community touts when trumpeting the research, and ultimately how the regulators view something as a "success" or not. But we patients struggle with the sole focus on A1C, since our diabetes lives are about more than just a number!
With CGM (continuous glucose monitors) being used more commonly these days and other contemporary tests like GlycoMark being available to look at glucose variability and deviation, it seems we ought to have options to go beyond just the A1C in determining how much benefit some treatment might have. Yet that's generally not yet happening. Dr. Beth Mayer-Davis from UNC Chapel Hill made an interesting point that she's been working to get CGMs used more in clinical studies, but that it's a tough sell because of the cost involved and the lack of recorded data to compare results to.
We also talked a lot about removing stigmas of "non-compliance or adherence," and it seems to me that expanding beyond A1C endpoints to other data sources could be extremely useful not only to show benefits, but as evidence of patients' efforts to keep their diabetes in check.
What stood out to me was how many of the organizations present indicated a high level of relationship-building with patients in recent years and more coordination in listening to the patient voice in their processes. And just getting all the players into a room to talk about the challenges and hurdles, as well as the common themes and points of agreement, was so encouraging!
That is of course what the 'Mine has been doing for the past few years with our Innovation Summit, but I've not personally been exposed to much of this dialogue on the R&D side outside of the device world when it comes to creating new medicines or treatments. And particularly not when it comes to the necessary clinical studies that go along with this research.
I also liked seeing the National Health Council and other disease states, like Parkinson's as represented by the Michael J. Fox Foundation (MJFF), being present and able to share what has worked or hasn't worked in their own communities.
One great example of this was during a discussion when the idea was floated about creating a sort of eHarmony or Match.com tool in order to match PWDs up with particular diabetes clinical trials. What do you know? The woman from MJFF stood up and said, "We've already done that." And indeed they did already use dating site algorithms to create a clinical trial matching service called Fox Trial Finder more than two years ago, and now have 23,000 patients registered!
This concept could be huge for the D-Community, and there was clearly a lot of interest at the summit about moving forward on something similar specific to diabetes. The JDRF had experimented with something like this in the past, and now Sanofi and others in the Pharma industry have been working with online community PatientsLikeMe to create a clinical study match service that will include diabetes data. Very encouraging -- seems like the perfect way to help more PWDs (like me) find interesting clinical studies that they would truly be motivated to engage in.
Registries, Kiosks and Academies?
As a group, those at the summit explored concrete steps that could be taken to increase patient involvement.
The T1DExchange Registry created by the Helmsley Charitable Trust, was held out numerous times as a model for how more patient interaction and involvement can be nurtured during this R&D process. They've been working on building a national type 1 data registry for several years now, and believe that T1DExchange can be a model to recruit more patient voices and "break down the information into meaningful language" for various audiences -- patients, clinical and regulatory experts, and industry. In one of the panel discussions, T1D Exchange CEO Dana Ball mentioned that his group is already talking with companies about a consortium that could help fund a type 2 registry -- which is hugely ambitious and therefore amazing!
Other ideas that were surfaced to help get more PWDs engaged in the process included:
- Installing kiosks at local community health centers or hospitals where patients could key in information to find a particular study.
- More patient-to-patient sharing and peer support during and after clinical trials, to share what the experience was like for others who might be considering involvement.
- Easy-to-read brochures in doctors' offices or local pharmacies, or even churches, that could explain the benefits of participating in this process. These would have to "go beyond science lingo, slight A1C drops, or other intangible aspects" that don't really get PWDs all too excited, we agreed.
Another note from the MJFF was the idea of holding local patient clinical trial fairs as a way to increase awareness and engagement. Now that would be an interesting idea, having something like a job fair but for diabetes clinical trials. Perhaps this could piggyback with local ADA Expos...?
There was also talk about creating something like a patient advocate university, similar to what the Innovative Medicines Initiative (IMI) in Europe has in its public-private initiative program known as the European Patients' Academy on Therapeutic Innovation (EUPATI). Basically, it brings patient advocates in for schooling about R&D so they can go out and communicate that information to other patients. Sounds like something that could really work well here in the States!
This all comes back to making the R&D process mean something to us patients -- from day one, when a company or researcher is exploring what a particular product or medicine might look like and what problem it might be solving for the end-user. Patient feedback should present from conception all the way through to the regulatory process, and the marketing strategy once this tool becomes available to us.
The challenge ahead is following through -- especially tricky when it comes to such a nuanced process that can take so long. We patients have to keep up the pressure, if we really want to see positive changes materialize.
As Bob Cuddihy, Sanofi's VP of Medical Affairs for North America, put it: "The diabetes field is crying out for patient engagement."
We couldn't agree more -- and are doing our best to spread the word and increase engagement from this end.
What else do you all see as ways for diabetes patients to become "Part of the Solution"?