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.
More from Clinical Trials
• By
Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
• By
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.
• By
The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.
• By
As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.
More from R&D
• By
As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.
• By
Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
• By
Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.