By Deborah Borfitz

February 21, 2019 | The quest for patient-centricity in clinical trials was the prevailing theme at the 10th Annual Summit for Clinical Ops Executives (SCOPE) held this week in Orlando. Setting the stage was an opening keynote about a longitudinal study at Verily, the first autonomous business unit of Google, which seeks to “map human health” and give value back to trial participants. Day two kicked off with a message from a physician with Johnson & Johnson (J&J) about the correlation between real-world data in trials with more meaningful medicines for everyday people.

Both companies are part of the FDA’s Pre-Cert Pilot Program and neither is likely to mistakenly refer to trial participants as “subjects”—an inappropriate if not retired term, as pointed out in song during opening ceremonies.

Trial listing site StudyKIK also made three patient-centric healthtech predictions for 2019: chatbots and artificial intelligence impact patient engagement, 5G mobile internet connectivity optimizes virtual screenings, and crowdsourcing empowers patients—think Kickstarter campaigns for raising research funds and literacy.

Data Ownership

Project Baseline is a two-year-old collaborative, cross-disciplinary effort of scientists, clinicians, engineers, patient advocacy groups, and regulators working to empower people to understand and manage their health through the return of individual research results, says Scarlet Shore, product manager and project lead. Step one is finding 10,000 people ready to take that journey. Participation involves clinic visits, recording daily habits, and changes in health in addition to receiving personal health insights.

Of the first opportunities available to Project Baseline participants, two studies (mood and type ll diabetes) are fully enrolled, a four-year observational health study has a waitlist, and enrollment continues for co-design sessions for new technology and devices. Online registration opened a few weeks ago, says Shore, and collects information regarding interest in clinical research and how results get shared back. Different recruitment channels will be promoted and tested, and experiments with the platform will determine what drives value for patients.

Verily’s partners on Project Baseline are Duke University and Stanford Medicine. One goal of the initiative is to ingest more phenotypic data collected remotely and at home, says Shore. Another is to make different types of information easier to compare at the individual and population level. A third is to make this normalized data useful to sites, sponsors and clinicians, and provide biomarkers of disease-related transitions.

The end game is to solve the data fragmentation problem and create an “end-to-end operating system” to run clinical studies that are easier to populate and monitor, leverage real-world evidence (RWE) and add a “bit of delight” to the patient experience, says Shore.

Pragmatic Trials

Up to now, clinical trials have been designed to answer only the questions of regulatory agencies regarding the safety and efficacy of medicines, says Emmanuel Fombu, M.D., MBA, Global Commercial Strategy and Digital Innovation, J&J. But what people and payers want to know is whether a drug works in the real world—based in part on self-reporting by patients and information generated by wearable devices.

Fombu cited Philips’ Actiwatch Spectrum built to track patients’ sleep habits and NovaSom’s AccuSom enabling home sleep testing. The next step is to capitalize on the vast amount of data being produced by such devices to spot trends and improve health outcomes, he says.

Last year, a staggering 400,000-plus Apple Watch owners were recruited into a Stanford-led heart study in under a year, notes Fombu. And later this year J&J will launch a research study to analyze the impact of Apple Watch and a heart health app on atrial fibrillation outcomes, including stroke prevention. The study will have drug, drug-and-device and placebo arms, he adds. If approved, the FDA would allow the Apple Watch to collect RWE in support of changes to drug products labels.

Blockchain will also have a role in making big data actionable, says Fombu, referencing a Bitmark Health app that encrypts activity data on smartphones and pulls the information into electronic health records. The technology gives sponsors the ability to circumvent health systems and Facebook to quickly find people to populate their post-marketing studies—the “missing link” in the clinical research enterprise today.