Guest Column | March 3, 2017

Open Source Data: Fact Or Fiction

Open Source Data: Fact Or Fiction

By Stephanie Petrone, Executive Director, Medical Operations, Novartis

At the recent Data & Technology in Clinical Trials conference, I had the pleasure of listening to Aneesh Chopra speak. Chopra is the president of NavHealth and formerly served as assistant to President Barack Obama and Chief Technology Officer of the United States. His speech was electrifying, dynamic, and set the room abuzz.

Chopra spoke of a future where government-funded, health-related API's will create an environment where anyone with basic coding skills and Apple ResearchKit could develop an app, grab the "free and open source data," and solve the world’s health problems. He even encouraged one audience member, a startup entrepreneur, to test it out right away and call the National Cancer Institute (NCI) with feedback.

Chopra also told the audience a fascinating story about the AIR Louisville project. The city of Louisville has one of the highest asthma rates in the U.S. In fact, The Asthma and Allergy Foundation of America has named Louisville one of the top 20 “most challenging” cities to live with asthma and the number one “spring allergy capital.”

AIR Louisville is a community program that uses smart connected inhalers to help make the city more livable for asthma sufferers. In 2012, Louisville partnered with Propeller Health and local backers to give 300 local residents a Propeller sensor (a modified GPS tracker) that fit on top of their asthma inhalers. The sensor uses an open source GPS API to discover hot spots of asthma attacks by geotracking inhaler usage. According to the AIR Louisville website, “local government leaders are using the citizen-generated data in anonymized format to identify hot spots of asthma across the region and to understand how environmental drivers are influencing these hot spots.”

The leaders hope the information will help them identify the areas where they should focus their intervention efforts in order to have the most meaningful impact on the asthma sufferers in the community. Officials hope to answer critical questions, such as how many asthma attacks could be avoided by reducing emissions by 20 percent along a particular highway, or by increasing the tree canopy by 10 percent in a certain neighborhood.

Wow. That’s an amazing effort by government and technology to assist patients.

But now for the reality check. These examples are astounding and increasing in frequency. We all know we are in the dawn of a new era of integrated health technology that will revolutionize the way we care for patients. But the critical question is: Where does this data live, and how can we get to it? The vast majority of health-related data is locked up within hospital and health center electronic medical record (EMR) systems. Hospitals across the nation are upgrading their EMR systems and integrating them across healthcare specialties. At the same time, a new generation of companies has sprung up to take advantage of this data parade.

As a lifelong researcher and personal advocate for better trials, I am enthralled by the prospect of using these new capabilities to address the fundamental question in clinical research, which is how to most effectively increase enrollment in clinical trials. Perhaps now we can finally improve our enrollment rates, which in 2017 remains an abysmal three percent industry wide. Unfortunately, with all of the advances we have made in healthcare, we still can't enroll trials in a timely way. And, as an industry, we still agonize over the delays created by the challenge of matching our trials to the right eligible patients.

I can go to any ATM and get money from my personal account from my own bank, regardless of who “owns” the teller machine. The solution in healthcare is clearly data access on a national scale. But we are still a long way from that goal. EMR technology is here. The open source concept is well understood. But our industry continues to implement it at a snail’s pace. The problem of each hospital or medical center EMR being disconnected from each other also remains. The data is there, but has to be accessed site-by-site in a slow and cumbersome manner. Although there is some data available at the national level, the data we really need in order to conduct complex inclusion/exclusion criteria assessment is buried deep in the EMR. That remains difficult to access.

I was inspired by Chopra's message, and I am grateful to work in this industry in a time of such promise. There are snippets of information coming to light to give us hope for the future. But, for now, the industry seems to remain analog in an ever more digital world.

If you would like to hear more insights from Stephanie Petrone, she will be a featured speaker at Clinical Leader Forum 2017, May 10-11 in Philadelphia. Clinical Leader Forum is a different type of conference. The focus is on issues and challenges important to you, actionable information you can immediately put to use improving your trials, and knowledgeable presenters who have faced similar challenges and overcome them. For more information or to register, please go to