Wednesday, March 5, 2014

Reducing Friction to Clinical Trial Participation: An Important New Collaboration

Today's guest post comes from Rahlyn Gossen. She is the founder of Rebar Interactive, a clinical trial patient recruitment and digital marketing company. Rahlyn also maintains a blog, newsletter, and Twitter profile focusing on digital strategy for clinical trials.

As I discussed in a previous blog post about the patient engagement app challenge, patient engagement offers great opportunity to improve clinical trials for patients and professionals alike. Though I am a fierce patient engagement proponent, this approach is not without limitations.

Clinical trials, as I witnessed during my five years as a research coordinator, demand perhaps more patient engagement than any other healthcare option. And that’s why we have a patient recruitment problem. Engagement is a finite and precious human resource. And some people need or want to devote that resource to their kids, work, or other areas. Can you blame them?

Engagement should not be a requirement for clinical trial participation.

In reality no matter how hard we try to engage patients, some will prefer a more passive role in their healthcare. Clinical trials should be a viable option for those patients too. As we work to engage patients, we should work in parallel to create a participation path for those who are disengaged.

For this reason, I have a great interest in not only patient engagement, but also in the overall patient experience. Thus far, a big focus of that interest has been virtual clinical trials, which offer unprecedented opportunity to integrate clinical trial participation into daily life. Given recent technological advancements and innovative proof-of-concept projects, I’ve had no shortage of inspiration related to this opportunity.

Meanwhile, efforts to integrate clinical trial consideration into daily life have been less inspiring. Until now.

Imagine if patients, at the click of a button, could share their electronic health records and be matched with trials in the clinicaltrials.gov database. Such a process would lower the engagement required to initiate clinical trial participation, while improving the patient experience dramatically. As a result, it would also improve clinical trial accrual.

This scenario could become reality, thanks to collaboration between Lilly, Novartis and Pfizer. The sponsors will now provide a “target health profile” for their clinicaltrials.gov trial listings. What’s unique about the target health profile is that it’s in a structured, machine-readable format. This consistent format is easy for both machines and humans to read, in contrast to the unstructured, dense jargon that has plagued the clinicaltrials.gov website.

This improvement alone is notable. But it gets better.

Lilly has developed an application programming interface (API) that takes data from clinicaltrials.gov and provides it in a web-friendly useable format. The API also augments the public clinicaltrials.gov data with additional information. For example, latitude/longitude coordinates for site locations enable the creation of a map-based user experience. Lilly’s API will now be updated to include the target health profiles enabled by this collaboration. And since Lilly’s API is open, anyone can use it to develop their own tools or software.

Furthermore, the target health profile will support matching against Blue Button+. Blue Button, if you are not familiar, is an initiative by the US federal government to provide patients with greater access to their digital health data. The initiative encompasses several areas, including the development of technical standards. Blue Button’s standards-based component is being called Blue Button+.

Using these tools, patient advocacy groups, academic institutions, and entrepreneurs can develop new applications to match patients to clinical trials. By facilitating the creation of these new applications, this collaboration may just enable the “one-click” matching scenario I described above. If you’ve followed Amazon’s rise to dominance over the years, you’ll know that reducing purchase friction to a single click revolutionized ecommerce.

Could a similar approach revolutionize patient recruitment too?

As Tom Krohn pointed out in a blog post about the collaboration, the National Cancer Institute estimates that fewer than 5 percent of cancer patients enroll in clinical trials. “If that percentage could be increased to just 10 percent of cancer patients, the average cancer-trial duration could be reduced to one year from the current three to five years.”

When this collaboration was announced in November of 2013, the initial proof-of-concept phase was expected to last through April of 2014. So I’m very excited to learn about the progress of this project on April 1, 2014 during the 23rd annual Partnerships in Clinical Trials conference. A representative from each collaborating sponsor will be on a panel titled “Enabling Patients to Match to Clinical Trials—A Unique Open Collaboration by Pharma Leaders.“

The panelists are:
  • • Joris van Dam, Strategic Projects Leader, Novartis
  • • David P. Leventhal, Director, Clinical Innovation, Pfizer
  • • Thomas Krohn, Director, Clinical Open Innovation, Eli Lilly and Co.

The panelists will focus on these topics:
  • • Background on unique collaboration between Pfizer, Novartis and Lilly along with 2 software providers
  • • Enabling patient-centric software providers through an Open API with clear study “Target Profiles”
  • • A readout of pilot project learning and next steps for expansion

Attending this Partnerships session is a top priority for me, and I hope to see you there.

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