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சுருக்கம்

New Strategies for Monitoring Clinical Trials during the COVID-19 Pandemic: Descriptive Cross-Sectional Study

Lucía Lavín Alconero*, Rita Nogueiras Alvarez, Tatiana Fernandez-Lanas, Jose Carlos Garrido, Laura Burunat, Celia Gonzalez Samperio, Miriam Cervino, Mireia Hernandez, María del Mar García-Saiz

Purpose: The adaptation of monitoring activities to the pandemic situation by COVID-19 has been reviewed in this article. The opinion of the personnel involved in the different stages of the clinical trial has been analyzed and compared with the exceptional measures proposed by the official authorities for the follow up of clinical research.

Method: During the months of July and August 2020, a cross-sectional descriptive study was started up using an online questionnaire with 53 items to evaluate the opinion of study coordinators, clinical research associated and project managers from public research institutes and private companies.

Results: The survey was completed by 107 clinical research professionals from the public and private sectors. It shows qualitative data related to their demographic information and significant differences in terms of public and private enterprise to adapt to the pandemic in terms of clinical trial follow-up visits, medication management, communication with the center and accesses to data verification.

Conclusion: When analyzing the data after a health emergency, we ask ourselves whether the measures applied are effective in maintaining the activity of the clinical trial and whether they comply with current legislation to guarantee patient confidentiality and safety. Recommendations are established for situations of this type, both for the clinical research professionals and for the patients involved in the clinical trial.