By Allison Proffitt

February 19, 2018 | It’s time we start hacking clinical trials, and Shwen Gwee, head of digital strategy and global clinical operations at Biogen, kicked off last week’s Summit for Clinical Ops Executives (SCOPE) in Orlando, FL by describing the MIT Hacking Medicine approach: break it down, build it up, and put it back together.

It's a fitting model for clinical trials as well. Gwee encouraged the SCOPE community to shoot for the "minimum viable product", not wait for what we consider a final product. The problem with the clinical trials industry is that we tend to launch and wait, he said. Instead we need to think in iterative cycles.

It is a push to move faster. Roslyn Schneider, global patient affairs lead at Pfizer, warns: the patient isn't waiting anymore. Digital engagement is happening whether or not we have a plan figured out, Schneider said. And digital engagement isn't limited to connections between sponsors and patients, she reminded, but patients are engaged with each other, and their healthcare providers as well.

In fact, patients connecting to each other is crucial, said Terrie Livingston, senior director of real world outcomes at Biogen. Livingston has multiple sclerosis. Her own diagnostic journey was not straightforward, and she shared some of the frustration, anger, and fear that she’s experienced along the way. She mentioned PatientsLikeMe and MyHealthTeams as examples of strong patient communities. Livingston is a member of MyMSTeam, the multiple sclerosis community run by MyHealthTeams. The most impactful and useful conversation she’s had about her disease, she said, has been with other patients.

The strength of such communities relies on the power of the network, said Gilles Frydman, founder of Smart Patients, an online community for patients and families affected by a variety of illnesses. Strong patient networks are full of what Frydman calls “micro experts”—not doctors, but people who know a lot about their own disease. There’s power in that kind of expertise, Frydman said. He even challenged the idea that it is the doctor’s responsibility to educate their patients on their disease. Maybe we are asking too much of them, he said. A network of well-educated patients would be better able to do that.

Bonnie Brescia, founding principal of BBK Worldwide, noted an even more worrisome trend: maybe doctors don’t have time to educate themselves.

For Livingston, part of the value of the patient communities has been in accessing the tips and tricks that can only really come from other patients living with the disease. Chris O’Brien, VP of strategic partnerships at MyHealthTeams agrees. Patients are sharing "lifehacks" that they aren't getting shared at the doctor's office, he said.

O’Brien believes that the MyHealthTeams model is so compelling because it is so very specialized. MyHealthTeams lets users input as much about their disease and medication history as they want, but the reward for sharing more is that the system matches them with others in the most similar situations.

MyHealthTeams does partner with sponsors for patient recruitment, but the litmus test, O’Brien said, is always, “Can we be fully transparent? Will this empower our patients?” If a project fits both of those criteria, he said, we are happy to partner for recruitment.

Biogen worked with MyHealthTeams to identify what matters most to MS patients. Fatigue, mobility, and balance were the top three issues that most impacted the lives of MS patients. However, when patients defined “disability progression,” balance and fatigue fell further down the list. For patients, disability progression was measured in lack of mobility, not being able to do normal life tasks like caring for their children and running errands, and other losses of independence. Patients don’t measure disability progression by MRI scans, Livingston emphasized, but rather in changes to their daily living.

The findings were not exactly what the researchers would have predicted. Capturing patients’ true needs, preferences, and value drivers requires systematic investigation, Livingston said. In this way, patient communities can be just as valuable to researchers as they are to patients.