Clinical Trials during COVID-19 Pandemic: A Methodological Concern.

Autor: Khosla, Prem Parkash, Sharma, Vidushi, Vir, Agamdeeep Singh, Goyal, Gurdev, Agrawal, Chanderpriya, Bhalla, Hira, Kishore, Surekha
Předmět:
Zdroj: JK Practitioner; Oct-Dec2021, Vol. 26 Issue 4, p75-78, 4p
Abstrakt: Background: Symptoms resembling adverse drug reactions (ADRs) in general population during Coronavirus disease (COVID-19) are a confounding factor. They can interfere with questionnaire or checklist used to monitor adverse effects of drugs and vaccines in clinical trials of COVID-19. Aim: To find background noise in general population during COVID-19 pandemic. Methods: An electronic survey was conducted after online consent and ethical approval. Participants were asked to check on a questionnaire any symptoms they had experienced during the previous 72 hours. Result: A total of 1004 responses were analysed. Symptoms were present among females (94.04), males (88.75), young (92.69), middle (89.09), senior age group (82.84), rural (89.53 and (92.6) percent in urban population. One to five symptoms were present in 33.29, six to ten in 26.32, eleven to fifteen in 17.79, sixteen to twenty in 9.62, twenty-one to twenty-five in 2.76, and twenty-six and above in 1.62 percent respectively. Conclusion: General population had symptoms despite of the fact that they were not suffering from COVID-19 or having any disease or taking any medication. This can cause erroneous reporting of ADRs in clinical trials of drugs or vaccines used for COVID-19. The design and interpretation of clinical trials during COVID-19 should take this in consideration. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index