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Digital clinical research is nearing a tipping point

Monday, January 18, 2016

The Pulse on Global Trials by Matthew Howes

Since I started writing this column two years ago, clinical research has seen modest improvements in failure rates of late stage trials, but for the most part drug development remains unnecessarily expensive and inefficient. 

Plagued by long-standing problems like patient recruitment and retention, clinical research has been slow to adapt to change, stuck in outdated, paper-based, site-centric business models.

Even with new tools and technologies at their disposal today, CROs still see recruitment rates as dismal as 0.5%.  For example, the University of Pennsylvania Health System conducted a mailing to more than 60,000 individuals, but netted only 305 participants. 

As the industry slowly tries to evolve, outsiders like Apple are catalysts in accelerating change in clinical research. 


In 2015, Apple introduced its ResearchKit, an open-source software framework designed to help doctors and scientists gather data more frequently and more accurately from participants using iPhone apps. The first five apps built on the platform have demonstrated significant progress in recruitment.

Stanford University reports that 11,000 iPhone owners signed up for a heart health study using ResearchKit in the first 24 hours. Alan Yeung, medical director of Stanford Cardiovascular Health, explained, “To get 10,000 people enrolled in a medical study normally, it would take a year and 50 medical centers around the country.” They ultimately recruited 30,000 participants within the first month.

Mount Sinai, another early adopter, created an asthma app and enrolled 7,500 participants in the first month. Participants start with a digital consent review that lets them choose what data they’re willing to share and who it can be shared with. Each day, the app asks a few simple questions about how the user feels, if she’s used an inhaler and if she’s taken her medication. That app also is automatically tracking the GPS location so that it can match back to other data, including pollen count, ozone, heat index and other asthma triggers.

Global pharmaceutical companies like GlaxoSmithKline and Purdue have upcoming releases expected soon. Apple’s ResearchKit is a particularly attractive option to collect patient-reported outcomes, which are becoming increasingly important as we move to a value-based approach to healthcare economics.

ResearchKit apps can use any of the iPhone’s sensors (microphone, camera, accelerometer, gyroscope, etc.) to gather information and integrate data from external health devices (like a fitness tracker, Bluetooth scale, etc.). The collected information comes to researchers on a real-time dashboard. With a click or tap, they can be sorted into subsets such as demographics, geography, medication adherence and smoking status.

While the functionality of ResearchKit apps opens doors for researchers to expand the scope of what clinical research can do, changes in other domains, like integrating big data, restructuring organizations and redesigning business processes, will be required to truly transform clinical research.

A look at investment dollars in digital health companies over the last five years indicates that we may be nearing a tipping point.  The next step is wide-scale integration and standardization among (electronic health records) EHRs and new, real-world applications.

Redox, a company founded by former Epic engineers, raised $3.5 million to advance an API for integrating software with EHRs. They work with a number of other EHRs, including some of the biggest names. The API currently is integrated with 120 applications, including those from tablet-based waiting room check-in company Phreesia, medical translator and monitoring device maker Phrazer and appointment scheduling software Clockwise.MD.

Major technology players like IBM and Intel, as well as healthcare leaders like ASCO and the Cleveland Clinic, are investing in solutions and methodologies to translate vast amounts of data residing in EHR systems into actionable medical information.

One partnership—comprised of Guardant Health and Flatiron Health—hopes to use big data to find cures for cancer. The companies believe the development of drugs to treat specific cancer mutations hasn’t kept up with the need because there are not enough patients in drug trials. With more data, there may be more, better treatment possibilities.

Flatiron Health is a cloud-based medical software maker that connects with the EHR systems of oncology practices to give them a broader view of how treatments are working. Guardant Health has developed a blood test to diagnose types of cancer, pinpointing how tumors have metastasized and how molecules have changed. By uniting the data, they’ll be able to show oncologists how a certain tumor with a specific genetic makeup responds better to one treatment compared with other chemotherapies. 


Matthew Howes is senior vice president, marketing innovation for PALIO, an inVentiv Health company. Email matthew.howes@inventivhealth.com.

This article was reprinted from CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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