Staying Connected After The Clinical Trial
Editor's Note: Jerry Matczak is the beloved founder of our digital efforts focused on clinical research education and awareness. He died unexpectedly in 2017, but his legacy lives on. This blog is one from our archives that he wrote.
Each year, thousands of people participate in clinical trials. Much of our recent focus has been on patients enrolling into trials, and what happens once they're in. But, what about what happens after trial? Patients and caregivers I've talked to have indicated that a lot more can be done to let them know that they are appreciated, and to connect them to the larger story of the treatments they are helping to bring into the world.
Data from CISCRP seems to support the anecdotes I'm hearing. They cite a 2008 survey (Getz. The Monitor. September 2008: 17-21.) in which most trial participants said they felt they were "no longer valued" by researchers. This is a shame. Advancements in drug development would not be possible without these volunteers. None of them should leave a study feeling unappreciated.
In fact, leaving them feeling this way can have further consequences. A different survey said that "most study volunteers choose not to advocate clinical research among patients who are considering participation." There could be any number of reasons for this, of course, but leaving them feeling abandoned after the trial ends certainly doesn't help. Actually, I would argue that delivering a great experience is the best way to boost enrollment in the future.
So, what can be done?
I think there are three main things:
- Acknowledge patients' contributions in a meaningful way
- Allow participants to access key data about the trial and themselves
- Invite them to be a part of the larger drug development story.
Acknowledge Clinical Trial Participants
A clinical trial is a team sport, involving participants, investigators, sponsors, and more. Teams celebrate their successes together. What happens after each SuperBowl, for example? There's typically a celebration in the winning team's city, involving the players, coaches, fans, etc. It brings the community together and sets the tone for the next season. So, wouldn't it be great if clinical trial teams could celebrate together? It could be a great way to validate participants’ contributions and pave the way to more participation in future trials.
One of the simplest but perhaps most overlooked things we can do for patients is to take the time to say thank you. What if once a participant completed a trial, they received an email of thanks? Maybe the message could include a video showing clinical trial staff members expressing their appreciation? It would be more of an emotional way to let patients know what their time has meant to us, and what it could mean to other patients who struggle with their same condition.
And can we expand on this, and memorialize clinical trial participants in a public and tangible way? The U.S. military is a lot of things, but I would not necessarily characterize it as a warm and fuzzy organization. Yet they do a much better job at memorializing their volunteers than the pharma industry. Memorials allow all members of the "team" to share in the success and to feel inspired by one another’s experiences.
For example, what if we invited participants to have brick with his or her name on it installed in a dedicated walkway outside of a pharma corporate headquarters? And, let’s not stop there—imagine it as a real, interactive experience. What if we could develop an app that would allow patients to upload a one minute video of themselves telling their personal stories? Anyone could visit the walkway and access a location aware app that would allow them to stop and see the faces and hear the voices behind the names as they walked along. Who knows, maybe they’d actually cheer us on?
These efforts would do a better job at allowing all members of the team to feel connected to the work behind clinical research in a meaningful, emotional way. It would help to remind everyone on "the team" that everyone's contributions, from the participant to the study coordinator, have a real effect on people's day-to-day lives.
Give Patients Trial Data
Research is about asking questions. Patients help us answer those questions, yet they don’t get to hear the punch line. A 2008 literature review conducted by CISCRP across 15 different studies, showed that about 90 percent of clinical trial participants wanted to know the results of the trial they participated in. Another study found that this almost never happens—Only 8.9 percent were able to find out. And, in yet another survey, 68 percent said that if they were not informed about the research findings after the trial they would not participate in future trials. Fortunately, are there are emerging ways to deliver this information through organizations like CISCRP.
But it’s not crazy to think that if patients want results of the trial itself, they’d also want some of their personal trial results. How about telling them what they took—were they on a placebo, a currently marketed drug, or the experimental drug? And tell them how they themselves did on the primary endpoint? Did key aspects of their condition improve during the trial? Does it seem that they did better while taking the investigational drug versus their usual treatment? This would be very important for patients and their doctors to know.
There’s all this talk of giving data back in machine readable, Blue Button format, and that’s ok for starters. But honestly, if I handed my doctor a thumb drive full of my data, I don’t think it would end up in my health record anytime soon. We need to find a way to provide this information to participants in a way that's immediately useful to them, i.e. a human readable format. Certainly a meaningful data visualization is the place to start. But what about something that’s more engaging and emotional? One way to do that, may be to follow Nike's example. Nike created a series of videos highlighting data collated from their Nike+ fitness app users:
In addition to the video dedicated to all users as a group, Nike also set up a microsite that allowed Nike+ users to automatically create a personalized video with their own collected data. What if we could do something similar with a more secure site built just for clinical trial participants?
So yes, let’s deliver key data in machine readable formats, AND also give it to them in a way that tells the story of their participation and of the treatment being tested. This may help them gain better insight into their own condition, and it would also make it easier for them to share these insights with their doctors and caregivers.
Yet another CISCRP survey tells us that patients also want ongoing communication after their trial. They don't want us to just give them their data and then kick them to the curb. Eighty six percent said they wanted "not only to be told the results of their trial, but also to be updated regularly" in the time between when their participation ends and the trial results are made public and beyond. How many patients knew their contribution led to a marketed drug that will help many others? They want and deserve to be part of this long story of how a new medicine engine works.
This doesn't mean that we need to be the boyfriend who won't go away, (You know, the one who keeps calling and calling even though you don't want to hear from him anymore? Ahem…just trust me on this.) We shouldn’t be randomly sending patients an email blast every month just because we can. Instead, we could allow patients to opt-in to receive additional, key updates on the study drug—things we already tell other audiences like investors and scientists. What would it take to appropriately share whether the drug has been filed with the FDA for approval, and also alert them when it's been approved or rejected? If it does get approved and branded, how might we fashion an appropriate VIP communication to the patients who helped make this a reality, particularly those patients who responded positively to the drug? And, speaking of which, is there an ethical way to facilitate the ability for those participants to access this new marketed medicine they tested on themselves?
What Do You Think?
There’s a great deal to be gained by being more transparent and making a more concentrated effort to better recognize and involve those who contribute to drug research. Respecting the heck out of participants is key to making clinical trial participation a positive experience and to helping encourage more people to participate.
What do you think? As a clinical trial participant would you like to be memorialized in some way? What kind of information is it important for you to have access to after the trial ends? Reach out to us on Twitter to let us hear from you.
Blog post originally appeared on LillyPad.