During clinical trials with medicinal products in early development phases (i.e Swissmedic recommends that researchers take an active approach by engaging in the current dialogue on dcts and liaising closely with the authorities as they plan and conduct dcts in order to ensure they fulfil applicable legal requirements. First in human application, early phase i studies) new investigational medicinal products are examined for the first time in humans
Initial insights are hereby collected on their tolerability and safety. It provides clarifications concerning the submission of trial documentation and gives information about different aspects of the clinical trial process, with references to other relevant documents and useful internet sites. The swiss agency for therapeutic products (swissmedic) has “comprehensively amended and updated” its position paper on decentralized clinical trials (dcts), including a comparison of what decentralized aspects of trial design are allowed in switzerland and other european countries.
The new position paper addresses the growing trend toward decentralized clinical trials, which leverage digital technologies and remote monitoring to conduct research outside traditional clinical settings. This guidance paper focuses on clinical trials with medicinal products and is intended for sponsors and researchers who are planning dcts and want to perform them in switzerland. While focused on switzerland, the position paper provides an interesting overview of the key regulatory and ethical considerations for conducting dcts, with references to internationally applicable guidance such as the good clinical practice guideline of the international council for harmonisation. This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials.
