![]() The vast majority of today’s population are millennials, who use digital technology daily for nearly all forms of activity - they expect healthcare to maneuver the same way. ![]() As a result, only about 3% to 5% of eligible participants get to enroll in clinical research and there is a 20% to 40% dropout rate for those who do enroll across all clinical trials. Participants must journey to sites that may be far from their homes - an average travel of two to three hours - when they could instead pick up a prescription at a local pharmacy, participate in telehealth visits, or use in-home healthcare. ![]() As a consequence, this makes the participant burden high, making it difficult to recruit and retain clinical trial participants. The majority of protocols today have an increased number of procedures or visits a participant would receive for their disease management in the normal course of care. The current, traditional system and clinical research protocols require many on-site procedures that take up participants’ time. The FDA is in the process of modernizing, but legacy frameworks are sometimes slower than participant needs. Since the 1980s, we have made limited changes to how we develop and test new medical products in clinical research. The more time and money spent in clinical development, the more participant lives are at risk. The current, traditional business model is not sustainable - it’s incompatible with the positive, disruptive changes that everyday technology enables. The push for a new model is crucial to executing successful and efficient trials. For example, it took 25 years for the industry to move from using paper to electronic medical records. Yet, despite many technological and telecommunications advancements, the healthcare industry is slow to adopt change. The technology we have today didn’t exist when we built this traditional model. Thousands of working processes depend on traditional paradigms. The industry unwillingness to adopt innovative changes is partly because the traditional model took a long time to build. Doing so will better integrate healthcare into participants’ real lives and accelerate approval of new medications. In this article, we’ll discuss the evolution of clinical research, how to adapt it to our current needs and life styles, and how to incorporate more hybrid decentralized trials (DCTs) and fully decentralized trials into clinical development. With advanced technologies now a part of our daily lives, clinical research has a a moral imperative to fix the traditional paradigms and ensure that every participant gets access to the best possible care. The result is a market where a new medical product costs in excess of $2 billion and takes over 10 years to get to market - if it even makes it to market. Digital health technologies (DHTs) continue to advance while clinical research remains slow to embrace efficient technologies and offerings that are widely being deployed in healthcare. The world and technology are racing ahead of the clinical trials industry.
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