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.