The Importance of Clinical Research Organizations (CRO) in Clinical Research and Impact of COVID-19 Pandemic
Author(s)
Dehlinger-Kremer M1, Lüning H2, Yaşaroğulları Ş3, Rolando D4, Mahi L5
1EUCROF, Haarlem, Netherlands, 2ICON PLC, Dublin 18, Ireland, 3Mene Research, Kocaeli Gebze, Turkey, 4Axelys Santé Fr, malakoff, 75, France, 5Axelys Santé Fr, Malakoff, France
Presentation Documents
OBJECTIVES: To investigate how the COVID-19 pandemic has impacted CRO activities and the implementation and conduct of CTs.
METHODS: An online survey of 52 EUCROF members was conducted between July and September 2022. Topics covered included the impact of COVID-19 on CTs and on in-field activities, and how CROs have come to terms with this reality.
RESULTS: The results evidenced that COVID-19 had significant impacts on CR activities. Key findings included: 77% of respondents adapted their internal organization, adopting home-based work, the most frequently reported negative outcomes were a slowdown in recruitment in CTs and the postponement of on-site monitoring visits. Approximately 61% set up remote visits and extended trial duration. 65% have been involved in COVID-19 CTs with, on average, at least two CTs fully dedicated to COVID-19. However, COVID-19 CTs represent less than 10% of respondents’ activities. 69% implemented new digital tools and 77% implemented the “Guidelines on the Management of Trials during the Pandemic” released by the EMA.
CONCLUSIONS: Investments in new technologies and processes have allowed CROs to adapt positively and quickly. This will enable them to deliver greater value to sponsors in a post-pandemic environment.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 6, S2 (June 2023)
Code
OP16
Topic
Organizational Practices
Topic Subcategory
Industry
Disease
No Additional Disease & Conditions/Specialized Treatment Areas