Article

EDITOR’S PERSPECTIVE

THE TRIALS AND TRIBULATIONS OF GETTING TO MARKET

As active practitioners in busy practices, one thing that we sometimes don’t keep in mind is that the medical devices and therapeutic drugs that we use every day all make their way to market through a sometimes complicated regulatory environment. This includes a clinical trials process to establish safety and efficacy (for drugs) or equivalence (for devices). Although sources vary slightly, it takes years (12+) and more than $2.5 billion to get a new drug approved (www.sciencedirect.com/science/article/pii/S0167629616000291?via%3Dihub ). Most of these costs come from the clinical trials work that is performed for the regulatory approval process.

Although drug and device development clinical trials can be perceived as lengthy and costly, I recently came across a report showing that our patients want to participate in these trials and believe that they are valuable in our healthcare ecosystem (www.eurekalert.org/pub_releases/2017-07/r-asd072517.php )! In fact, 86% of the respondents reported believing that their healthcare professionals should discuss clinical trial opportunities with their patients as part of their routine care, if applicable. Another 87% of respondents believe that clinical trials are important to advancing our nation’s health.

I believe these data are encouraging and present an opportunity for not only our patients, but also for our practices to be involved in clinical trials. In doing so, there are potentially direct benefits to your patients and your practice. And, more importantly, you both end up participating in the betterment of our healthcare environment at a much greater level.