The COVID-19 pandemic has helped demonstrate the feasibility and benefits of conducting decentralized clinical trials (DCT), but it has not “flipped the switch” on their acceptance by health authorities globally.
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 new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
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While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.
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Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.