A new publication in the medical journal Lancet entitled “Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study” highlights the requirements of sponsors of applicable trials to report their results directly onto ClinicalTrials.gov within 1 year of completion. Within the EU, sponsors have also been required to post results to EudraCT within one year after the end of a clinical trial (or six months for a paediatric trial) since 2014. The Lancet study suggests that compliance still needs to improve, especially with smaller and academic sponsors.
Asphalion has experience with posting clinical trial results, transparency and providing support for other clinical trial. We can also give support on IND-related procedures and documentation as well as providing advice, and services including outsourcing for small and larger sponsors alike.
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