| Autor: |
Francisco Harrison, Rino Coladangelo, Maël Heutte, Timothy Colin Hardman, Stefano Marini |
| Rok vydání: |
2022 |
| DOI: |
10.21203/rs.3.rs-1118410/v1 |
| Popis: |
Background: The COVID-19 outbreak was declared to be a pandemic by the WHO in March 2020. Ongoing clinical trials were suspended, some never to re-start. A survey was conducted to get a better understanding of both the successes and failures in dealing with the pandemic.Methods: European contract research organisations (CROs) were asked to determine the extent to which the pandemic impacted on their operations in terms of the trial site conduct and investigator performance as well as its impact on subjects and patients involved in ongoing trials and the quality of data generated. Results: Forty-nine companies provided responses to the questionnaire. Data indicated that the challenges faced during the pandemic had a marked impact on clinical trial conduct and delivery. We saw an almost immediate decline in clinical trial activity associated with reduced subject/patient recruitment and a reluctance of study participants to undergo follow-up due to their fears of exposure to infection. There was insufficient data to determine the full extent of the pandemic on clinical trial performance and associated limitations in access to bed spaces and the resources necessary to perform procedures and subject follow-up. The introduction of remote monitoring by CROs provided the opportunity for essential activities associated with clinical trials to resume/continue. However, implementing these solutions required research organisations to implement changes to trial documentation and procedures. This placed marked burdens on budgets and clinical resources.Conclusions: Those involved in clinical trials advanced a flexible approach to addressing the challenges posed by COVID-19, with all parties working closely together to find solutions. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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