Partnerships 2013: The Great Inflection of Clinical Trials

The concept of “leaning in” has generated a lot of discussion recently. This discussion was spurred by Sheryl Sandberg’s book about women in the workforce, titled Lean In.

I have yet to read Sandberg’s book, but I’ve long embraced the concept of “leaning in” when it comes to change and uncertainty. If you own a business, and particularly a technology oriented business, that attitude is somewhat necessary.

Given the current challenges of drug development, those that lean in to uncertainty will be those that survive and thrive over the long term. And those that drag their feet on the path to inevitable change will find themselves in an increasingly difficult position.

For this reason, I most value conferences that help me to lean in to change and uncertainty. This year’s Partnerships in Clinical Trials conference helped me to do just that. I was exposed to many people and ideas that lean in to changes in drug development, thus enabling me to do so as well.

I can’t possibly do those people and ideas justice in a blog post. But I do want to share a few sessions that I personally found to be most valuable in this regard.

The Future of Drug Development in a Digital World

Eric Topol, MD is the author of The Creative Destruction of Medicine. I’ve read his book, and it is a fantastic science fictionesque glimpse into the future of healthcare, much of which is becoming a reality today.

Topol is also widely considered by many to be the single greatest thought leader in digital health. And because “digital health” will ultimately just be called “health,” that pretty much makes him the single biggest thought leader in healthcare too.

So when I saw that Topol would be a keynote speaker at Partnerships, my inner health tech geek rejoiced. Needless to say, Topol lived up to my expectations in his presentation, titled “The Future of Drug Development in a Digital World.”

The biggest theme of Topol’s talk was the democratization of medicine. Historically, health information has been held by a small minority like doctors and pharma. The result was information asymmetry, with the few acting as gatekeepers to information for the many (patients).

In the new healthcare model, which is currently emerging, patients are achieving information parity. Increasingly, patients will drive the direction of healthcare, demanding that there be “nothing about me without me.”

This shift has big implications for drug development, which will move from top-down processes to bottom-up processes. Networks of patients will have the ability to crowdsource the sharing and creation of knowledge, eliminating pharma’s exclusive control of the drug development process.

The Key to Connectivity: Opportunities for Disruptive Innovation in Clinical Trials

Following his presentation, Topol participated in a panel with Jamie Heywood of Patients Like Me and Craig Lipset of Pfizer. Topol’s speech, along with this panel, was undoubtedly the talk of the conference. It challenged the very foundation of the clinical trial model.

Topol argued that we are moving out of the placebo-controlled world as we gather new information, and we will be conducting far smaller trials. Topol also believes that we are not capturing the right data, arguing that genomics and sensors should be incorporated into clinical trials.

Jamie Heywood, in particular, pushed the envelope in his predictions for the future of clinical trials. In fact, Heywood questions whether clinical trials will exist at all in the future, ultimately being replaced by data collected from groups of networked patients.

On more than one occasion, Topol strongly suggested that every member in the audience be on Twitter. He said that Twitter was his single best tool for keeping up with the dizzying pace of healthcare innovation.

I could not agree more. Clinical trial professionals that are on Twitter are at an information advantage. And being that we live in an information age, that’s a pretty big deal. Furthermore, I truly believe that if more clinical trial professionals were on Twitter, we would see far more rapid innovation in clinical trials.

So I was very pleased to be approached by several people after Topol’s session who asked for help getting started with Twitter. If you too would like to take Topol’s advice and use Twitter, here’s some resources:

• Twitter for Clinical Trial Professionals (Part 1) – The first part of a two part series
• Twitter for Clinical Trial Professionals (Part 2) – The second part of a two part series
• The Why and How of Social Media for Clinical Trial Professionals – Recording and slides for a webinar, which I recently did with Applied Clinical Trials
• Companion Blog to Social Media Webinar – Companion blog post for the webinar, which includes Twitter resources
• Applied Clinical Trials Twitter Chat – Upcoming tweet chat, which is a followup to answer questions from the webinar

Case Study: Eli Lilly’s Clinical Open Innovation Initiative

I’ve been following the work of Lilly’s Clinical Open Innovation (LCOI) team closely and am very impressed by it. So it was a pleasure to have Tom Krohn from LCOI share his team’s progress during this session.

Krohn pointed out that our current R&D model is unsustainable and argued that incrementalism will not pave the road to sustainability. What we need is disruptive innovation.

LCOI is spurring disruptive innovation through what Krohn and his team call the Open Clinical Intelligence Network (OCIN). The OCIN is constructed according to LCOI’s “4C Model,” which is:

• Collect
• Consume
• Curate
• Connect

To learn more about this model and what LCOI is up to, I urge you to read Krohn’s excellent white paper, “Clinical Open Innovation.” Also check out the LCOI blog, which is a must read for those interested in clinical trial technology and transformation.

Krohn shared a very noteworthy tidbit during his presentation. Clinicaltrials.gov gets 95 million page views per month. Forty-eight percent, or 45.6 million, of those page views come from patients, their loved ones, and caregivers. And yet, the way we present study information is not at all patient centric.

This tidbit proved to be a nice segue for Krohn to announce an important LCOI initiative. In the summer of 2013, LCOI will host a patient-centric study representation challenge. The goal of this challenge is to generate new designs that represent study information in an appealing and useful manner for patients.

Such challenges have been used in other healthcare contexts to surface solutions to vexing problems. On a shameless plug note, Rebar Interactive was recently selected as a finalist in the Shire ADHD Transitions Challenge. To my knowledge, LCOI’s challenge is the first time a challenge has been issued in the clinical trial arena.

Crowdsourcing & Telemonitoring Deliver Better Data at Lower Cost

Transparency Life Sciences, in partnership with AMC Health, is working on a clinical trial that is unique in two key ways. First, the protocol is crowdsourced. And second, most of the study visits are being conducted using telemonitoring, rather than with visits to research sites.

Tomasz Sablinski with TLS and John Holland with AMC Health shared information about their clinical trial (and the benefits of it) in this informative presentation. Applied Clinical Trials editor Lisa Henderson recently wrote an excellent article about Transparency Life Sciences. So to keep this blog post a manageable length, I’m going to forgo getting into the details of the presentation and suggest you read her article.

Leveraging Data & Technologies to Achieve Superior Patient Engagement

If I were a movie reviewer, I’d call this session my personal “sleeper hit” of the conference. I had high expectations (which were met) for the sessions previously described in this blog post. But walking into this session, I had no knowledge of the project that would be presented or how innovative it would be.

As I listened to the presenters, it became increasingly clear to me that this project would have important long-term implications for virtual clinical trials, and thus clinical trials in general. Actually, I’d argue that the implications go beyond clinical trials and into the broader healthcare system.

Larry Brooks with Boehringer and Abbe Steel with UBC presented “Leveraging Data & Technologies to Achieve Superior Patient Engagement and Biometric Health Improvement in Patients with Diabetes.” That’s kind of a mouthful. So what made this session unique?

Brooks and Steel described their progress on an extremely innovative project that is currently underway. For this project, Boehringer and UBC partnered on an app to improve health outcomes in T2 diabetes. And they are measuring the efficacy of this app with a virtual clinical trial.

The diabetes app includes:

• Digital health behavior modification and coaching
• Personalization
• Glucose monitoring
• Blood pressure and weight monitoring
• Smart phone and web delivery

To measure the ability of this app to improve outcomes, Boehringer/UBC are conducting the Self Management Action Plan Through Research Technology (SMART) study. This study is enrolling 1,000 adults in a program where they will use the diabetes app. The data from these patients will be compared to patients in the Medco claims database, which is to serve as a control.

The SMART study will enroll its first patient very soon, and I look forward to hearing about how things progress. In the meantime, Brooks and Steel shared five important lessons learned thus far:

1. Siteless studies are uncharted territory – This new territory caused unexpected delays.
2. Employer selection is critical – They partnered with large employers for patient recruitment.
3. Have multiple backup plans – Because siteless studies are uncharted territory, your initial plan may not be feasible.
4. Interactive = More content to approve – The IRB approval process was more arduous and lengthy than what is typical for traditional studies.
5. More partners + Uncharted territory = Lengthy protocol development – Steel believes the delay has been worth it and will ultimately make for a stronger study.

In previous blog posts about the challenges of the Pfizer virtual trial, I discussed how virtual trials would need to evolve in order to be successful. The work that Boehringer and UBC are doing is a huge leap in that evolution, so I find it to be a very important advancement.

The Great Inflection of Clinical Trials

During Topol’s talk he said that we are undergoing “the great inflection of medicine.” I left Partnerships in Clinical Trials thinking the tendrils of that inflection are now making their way into clinical trials.

As much as Topol’s ideas excite me, I was far more excited to learn about the work that Lilly, Transparency Life Sciences, and Boehringer/UBC are doing. I suspect this won’t be the last time I write about their work, which represents meaningful movement towards more patient centric clinical trials.

The work of these companies suggests that we may be at a tipping point. It seems that we are on the verge of disruptive innovation to clinical trials.

Image Credits:
Partnerships in Clinical Trials Blog
Lilly COI Blog