Leveraging Technology to Bridge Clinical Trial Processes and Real-World Health Care

Technology adoption in health care delivery has already surpassed anything we’ve done in the drug development industry. In health care, mobile technology and mobile engagement allow patients to interact with their caregivers, health care delivery, and pharmacists. In the drug development industry, however, we have not kept pace with how people use mobile phones, smartphones, and iPads to engage with their daily lives.

In the millennial generation, roughly 30 to 40 percent do not have a primary care physician. Instead, these millennials access their health care delivery through ambulatory clinics or engage with health care providers via mobile devices. Even people in their 60s or 70s often use mobile technology for health care delivery needs such as chronic disease management and medication alerts. Beyond health care, the daily routines of individuals across all age groups include the use of technology.

Building upon the usage of technology in health care delivery, integrating technology into clinical research as a care option will be a game changer in achieving greater participation in clinical research and decreasing the overall time for trial completion.

Technology disruption in health care

Between 2013 and 2017, Alphabet, Apple, and Microsoft collectively applied for more than 300 U.S. health care patents, signaling an increased technology presence in the health care space.¹ In an effort to tackle the status quo, Amazon, Berkshire Hathaway, and JPMorgan Chase are collaborating to simplify health care and drastically reduce costs.

These tech giants have also influenced the health care landscape among payers and providers. In a proposed $69 billion deal, one of the largest in U.S. health care, drugstore chain CVS is acquiring Aetna, the largest health insurer. Other deals have recently been announced, such as Cigna’s acquisition of Express Scripts and Albertsons’ acquisition of Rite Aid. These consolidations can reshape health care relationships and capabilities, profoundly affecting patient participation and experiences. Even Lyft and Uber have entered the health care space, leveraging their ride-hailing services for patient transportation and prescription pickup.

Once the big tech players get into this space and own that relationship with the patient as a consumer, it will be difficult for pharma and biotech to come back. Patients will be less inclined to participate in trials because the barriers to participate take them so far out of their normal routine for their health care delivery.

The biotech and pharma companies have an opportunity right now to own that patient engagement, either through mobile technology or technology engagement such as Bluetooth and wearables. The people who know drug development best and understand the intricacies of bringing drugs to market are still the health care and science professionals within the CRO space, pharma, and biotech. All that depth and understanding are necessary to be able to apply the technologies appropriately to gain the most efficiency and opportunity, compress trial timelines, develop greater patient engagement, minimize the barrier to entry, collect more data in real time, and ensure patient safety. Technology by itself won’t solve all the problems. The industry needs that skill set and knowledge base.

The value of virtual clinical trials

“Virtual trials” can be a misnomer. They are not replacing every physician visit with technology or a virtual visit. Rather, enough data exists to understand the total patient journey, in terms of how patients are being treated for their disease in the real world, how we use that data and our understanding of the patients’ pathway to treatment, and how to optimize the clinical protocol. The value here is on minimizing the patient burden to participate in research.

If there are 10 or 12 visits in an average clinical trial, then through wearable devices, Bluetooth technology and mobile platforms, potentially half of those visits could be conducted in a virtual model, with the data pushed directly to the provider. The use of virtual visits can enhance safety while reducing the burden on both patients and trial sites. Thus, more real-time data reaches the physician in a more effective and efficient manner. Patients can more easily participate in trials, as they do not need to go to the clinic and step out of their daily routines on multiple occasions. Rather than entirely replacing that connection between the physician and the patient, we’re augmenting it so that no one makes visits for what can be done and collected in a virtual environment. The trial is still safe, effective, and well managed.

There may even be trials in a 100 percent virtual environment, either through telepresence visits with Teladoc or virtual visits via smartphone, with the incorporation of Bluetooth-enabled devices. If we can collect vital statistics from a patient via their own device, hundreds of medical-grade devices approved by the FDA can push the data directly into a mobile platform that can then be shared with a health care provider.

The drug development industry is starting to move forward. Several companies have already indicated that their goal is to move to an almost entirely virtual clinical trial model. Pfizer was on the forefront of that almost a decade ago. Now, Novartis is partnering with Science 37 for 10 virtual trials over the next three years, to move forward with a more virtual, “site-less” model. Virtual participation can improve the diversity of trial participation and, therefore, broaden the collection of real-world evidence in clinical research. Once these companies demonstrate the benefits, the dominoes will fall quickly for the rest of the industry.

Meeting stakeholder needs in clinical research

The reality is that patients have choices whether to participate in research. There may be five, six or seven drugs currently in clinical trials for some indications, particularly for chronic diseases, so patients also have an option as to which trial to participate in. One of the biggest challenges is recognizing that patients who participate in trials are actually consumers first.

If you look at the 21st Century Cures Act and similar regulations, government agencies are encouraging pharmaceutical and biotech companies to leverage these technologies to enhance the ability for patients to participate in trials. We still must ensure that the data we collect is robust, auditable and clean, and that it tells the appropriate story to regulators that justifies or supports the mechanism of action of the drug and the impact on the disease state.

Technology is not going to solve everything. However, with a new molecular entity currently averaging more than $2 billion and 10-plus years,² we need some sustainable solutions. By leveraging technology to make clinical trial participation less burdensome for all stakeholders-including patients, physicians, sites, and caregivers-we can decrease overall timelines and costs, getting new therapies to market faster.

Kent Thoelke

Kent Thoelke, Executive Vice President and Chief Scientific Officer, PRA Health Sciences, and member of the Advisory Committee of the Bridging Clinical Research & Clinical Health Care Collaborative

Joan Chambers, Senior Strategic Advisor, and NaomiFujimoto, Senior Copywriter, both with SCORR Marketing and the Bridging Clinical Research & Clinical Health Care Collaborative References
1. When the Human Body Is the Biggest Data Platform, Who Will Capture Value? https://webforms.ey.com/Publication/vwLUAssets/ey-when-the-human-body-is-the-biggest-data-platform-who-will-capture-value/$FILE/ey-when-the-human-body-is-the-biggest-data-platform-who-will-capture-value.pdf

2. Tufts CSDD Assessment of Cost to Develop and Win Marketing Approval for a New Drug Now Published. http://csdd.tufts.edu/news/complete_story/tufts_csdd_rd_cost_study_now_published