Is Clinical Data Management the Next Taxi-vs-Uber Situation?
posted: November 21, 2019
When Uber created its ride-sharing app, it brought the old college standby of sharing a ride online and into the transportation mainstream. It addressed a very real frustration people had when trying to get around, especially in urban areas where the streets are congested and parking is non-existent or wildly expensive. Before Uber, choices were limited to taxis (not a lot of them, and expensive), airport shuttles (lots of stops, limited schedules), and friends or family. Uber went around the industry establishment, directly to the customers, and gave them easier, fast access to what they needed.
Are clinical trials and the data they generate ripe for an Uber-like disruption? In a word, yes.
You likely know these stats. Clinical trials:
- Take around 8 years to get therapies to market, sometimes longer.
- Cost around $2.6 billion.
- Struggle to find, and retain, participants: 85% fail to retain enough participants.
- 40% face challenges in meeting enrollment goals to begin with.
“But wait!” you say. “We’re digitizing all kinds of things in the health/medical/clinical arena! We've got electronic data capture, and electronic health records, eSource, electronic CRFs, and more!”
True. There are elements related to clinical trials that have moved to digital solutions.
But the pharma/health/medical industry tends to be slow-moving and reactive. Which isn’t always a bad thing, since people's health and well-being (and lives!) are in the balance, but it makes the industry ripe for a Silicon-Valley-style, tech-led disruption.
The Big Players are Already Here
The big tech players have been involved in health care to some extent for about 10 years, and are expanding into life sciences research as well. It makes sense--Medical research, clinical trials, drug development, tend to all turn on one main element: Data. And the big tech companies have become data whizzes. They collect unimaginable amounts of data daily, hourly. They've been doing it for years, and they've had the time, the money, and the staff to figure out how to interpret it and how to use it.
Google is making big investments in genomics, healthcare application research and HIPAA compliance in the cloud, with much of that work being done through its Calico, DeepMind, and Verily divisions. Project Nightingale has just come to light in the news, with Google and Ascension Health collecting patient data without telling the patients.
Verily, the life sciences division of Alphabet, Inc. (Google’s parent company) announced earlier this year a partnership with Novartis, Otsuka, Pfizer, and Sanofi, "to implement research with a more tech-driven approach and to reach a wider range of clinical research participants." Project Baseline, a current Verily project, is intended to bring clinical research and clinical care closer together. The Baseline Platform is "an evidence generation platform"; it appears right now to be about recruiting people for clinical trials.
“Verily and its industry partners hope to use the Baseline Platform to collect, organize and activate health information from electronic health records, sensors and other digital sources. In the coming years, Novartis, Otsuka, Pfizer and Sanofi intend to start clinical studies using the platform in areas like cardiovascular disease, oncology, mental health, dermatology and diabetes."
Amazon's health insurance company, Haven, is expanding to cover 30,000 employees. Amazon also acquired internet pharmacy PillPack, it’s actively building at-home medical diagnostic kits, and it’s built a product to mine patient health records. Pretty soon Alexa will be able to tell whether you’ve had a cold.
Amazon and Apple both have started building independent health clinics.
Recently, Facebook announced a preventative health tool that makes recommendations for checkups and screenings based on users' demographic factors such as age and gender. They promised they won’t be sharing that information with health insurers or hospitals.
The thing about Uber was, it scratched an itch. Finding a ride wasn’t a huge problem, plaguing people constantly. But when a viable solution was offered, suddenly people realized what they had been missing.
Clinical trials are not that different. People don’t necessarily know what they’re missing, but as the tech companies connect people directly via apps and portals to their own health care records, and to their providers, and give them options to have greater control over their own treatments, there will be a growing demand for life-saving, life-changing, therapies and drugs. Up until now, clinical trials, although focused on patients, have been fairly patient-unfriendly. Physically—patients often have to travel a long way to reach their test site, and practically—demanding time, adherence, reporting, etc.
The big tech companies and smaller, innovative, agile ones as well, are adept at taking their case, or their product, directly to the people.
What’s the Next Move for Clinical Ops?
Embracing digitization within our various companies is a good start. But as an industry we need to shake some of our resistance to change and newness, and start thinking in terms of connected systems.
One of the big challenges with bringing clinical trials and clinical data fully digital is interoperability. There are many systems and methods out there, all different, all separate. Maybe a single database is too much to ask, but what about a separate, healthcare internet, with very limited access points, where all kinds of health-related data could live. From people’s health records to data captured from wearables to clinical data received during trials.
There need to be solutions that allow pharma and biotech companies to retain their proprietary information, but that reduce the friction and amount of time it takes to get trials to completion.
You and I may not have the answers individually, but if we come together as an industry we can solve this problem before the Big Nine tech companies stage a coup and take over.
If we, the data managers, data scientists, and clin ops, are actively engaged in creating the future of clinical trials and clinical data management, we can ensure that the tools developed don't lose sight of the patients even as we create solutions to streamline trials, that the quality of the data continues to be a primary focus, and that our industry stays viable and effective.