Supporting FDA's DHT Framework
In December 2021, the FDA issued a draft guidance document related to digital health technologies (DHT) for remote data acquisition in clinical investigations. This was much anticipated guidance that provided high level definitions and principles on DHT use in clinical trials. It further provided clarity on what is required to evaluate DHT use and some important considerations for clinical trial sponsors and technology providers.
Today, the agency released the Framework for the Use of DHT in Drug and Biological Product Development which outlines how the agency is going to work with stakeholders to make DHT deployment in drug development a reality. This new document is not a guidance document nor does it propose or establish policies. This is a roadmap for digital innovation in medicinal products which brings collective knowledge and expertise across multiple divisions of the FDA, fully recognizing the tremendous potential of DHTs and also challenges of implementing these innovative tools. This framework shows continuous FDA commitment to promoting technology innovation and patient-centric approaches to drug development. An important aspect of this document is the announcement of public meetings to be held in 2023 to gather input on issues related to DHT use.
At Koneksa, we fully embrace opportunities and challenges of DHT-based drug development innovations. We are looking forward to participating in public forums and contributing our knowledge to make drug development more efficient and bring much-needed treatments to patients.