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

BACKGROUND: CROs play a major role in ensuring clinical trials (CTs) are executed in line with ethical and regulatory requirements, ultimately to support the development of new drugs that benefit patients worldwide. To meet the evolving needs of pharmaceutical and biotech companies, CROs have expanded their services they provide. Innovations in the areas of decentralized trials, artificial intelligence and patient recruitment strategies, among others, enhance efficiency and help bring new life-saving drugs, therapies and medical devices to the market faster. As a result of how they adapted during the pandemic, the value CROs deliver has increased significantly, thereby strengthening the role they play in the industry overall.

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

2023-05, ISPOR 2023, Boston, MA, USA

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

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