Embracing Decentralized Trials Is Not ‘Plug And Play’
Trial sponsors are proactively seeking opportunities to incorporate decentralized elements into their studies, but the lack of regulatory guidance makes it a difficult exercise.
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The upcoming EU guideline on decentralized clinical trials is the result of a “learning by doing” exercise and builds on various pilots and initiatives launched by different member states.
The COVID-19 pandemic has given a new impetus to Sweden’s ongoing efforts to support decentralized clinical trials.
A new position paper outlines several factors that sponsors must consider when planning to undertake decentralized clinical trials in Switzerland to ensure compliance with national legal and ethics requirements.