MedCity News June 12, 2023
The FDA has made a purposeful choice to write in broad strokes, stopping short of detailing ways to execute DCTs. Even so, the Agency is starting to acknowledge – and thereby support – the global shift towards expanded trial models. Essentially, the FDA is implicitly broadening the definition of clinical trials.
When regulators speak, we listen.
Naturally risk-averse industries like the life sciences need health authority acceptance before trying new approaches and especially before committing to wholesale operational change, even if the outcome has great potential. Consider decentralized clinical trials (DCTs) – a new model for conducting research. DCTs saw a sudden uptick during the Covid-19 pandemic but they are still not ubiquitous industry wide despite their significant benefits.
The...
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