Challenges Digital Health Startups Face in Conducting Randomized Clinical Trials
Abena Ansah-Yeboah  |  November 12, 2018
With investment deals totalling up to of $3.4 billion in June 2018 [1], it is no secret that the digital health sphere is currently experiencing a strong, upward trajectory. As funding season rolls around, thousands of startups are pitching their product or service to investors in hopes of obtaining the necessary assets to transform the healthcare system through modern technology. However, the digital health market is becoming increasingly competitive, with investors raising their expectations and relying on proven outcomes, as opposed to ambitious statements and consumer hype, to allocate their funds. Startup companies are taking it upon themselves to prove that claims to "reduce costs", "save time", or "improve health outcomes" do indeed have merit through the conduction of randomized patient trials.
One such company, Reflexion Health, partnered with the Duke Clinical Research Institute (DCRI) to carry out the first 30-month randomized, controlled trial comparing virtual physical therapy using the Virtual Exercise Rehabilitation Assistant (VERA) to traditional physical therapy. Although the clinical trial proved to be a success, with nearly $3000 saved per patient using VERA, here are some challenges encountered along the way that other companies could experience[2]:
  • High costs
    Randomized, controlled trials can be very expensive with Reflexion spending over $2 million in direct costs alone, which could pose as a lofty financial investment for many startups companies.
  • Prolonged timelines
    Aggressive timelines must almost always be extended for clinical trials, as recruitment often takes much longer than anticipated.
  • Business & academia misalignment
    Academic and company schedules rarely align, with universities working within semesters while small companies must adhere to quarterly reporting schedules and monthly burn rates. This results in different senses of urgency to undergo trials and obtain results, and in cases of publication (e.g. The Journal of the American Medical Association.), strict requirements can often lead to lengthy review and submission periods.
  • Loss of control
    Positive clinical trial outcomes, as with any study, are not guaranteed. It is possible for poor results to not only affect individual companies, but the entire area of healthcare that their product or service caters to.
  • Competitive considerations
    For favorable results that prove a company’s health product to viable solution, there is potential to encounter an unforeseen "halo effect". Competitors offering products in the same health sphere could in fact benefit from another company’s results, and it is important to meticulously design your study such that your company will get a return on its investment.
In order for digital health startups to truly innovate healthcare delivery and outcomes, they must provide both clinical and economic evidence for the value of their products. Unfortunately, the challenges above illustrate that the execution and publication of randomized, controlled trials are ill-suited for health startups, and it is important that companies communicate their needs and timelines to research organizations in order to expedite the process of collecting clinical results in a fast-moving market. Finding a means of mapping clinical, academic, and business timelines in a manner that streamlines proof of value is key to assessing and maintaining the value of digital software in modern healthcare.