Decentralized Clinical Trials (DCT) are here to stay!
In 2007, the FDA and Duke University partnered to develop and drive the adoption of practices for increased quality and efficiency of clinical trials and formed Clinical Trials Transformation Initiative (CTTI). Almost two decades later, with an involuntary boost from the COVID pandemic, global regulatory authorities are publishing legal guidance for DCTs. The growth of digital technologies provides tools that make DCT possible faster and more efficiently with reduced cost. Using DCT, where appropriate, allows products to be on the market faster; however, challenges are also present and should be addressed. MEDIcept is presenting this paper as an introduction to an upcoming series of papers focused on DCTs discussing the regulatory environment, benefits, challenges, tools, and potential solutions.