ABSTRACT
The central drugs standard control organization (CDSCO), Indian national regulatory authority under the Ministry of Health and Family Welfare have revised the clinical trial regulations in 2019 and there was a tremendous change in the approach for regulatory approvals due to the COVID-19 pandemic. A tremendous strain has been observed on the clinical research activities due to the COVID-19 pandemic which involves the redirection of resources and avoidance of personal meetings. Therefore, an urgent need of innovative solution was identified to enhance the overall performance clinical research during this pandemic. The innovative solutions include involvement of digital biomarkers, digital information consent form, digital health record and digital case report form. In the present study, impact of new drugs and clinical trials rules 2019 and COVID-19 pandemic on clinical trials applications received by CDSCO and evaluated by Subject Expert Committees (SEC) have been analyzed retrospectively. The author concluded that new drugs and clinical trials rules were enforced recently by the regulatory bodies to meet the requirement of emergency medical conditions. A large number of variations in the clinical trials application were observed in terms of the types of trial and the procedure after the implementation of new clinical trial rules.
ABSTRACT
Severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) belongs to the beta corona virus genera of the Coronaviridae family, which is a pathogenic virus that causes coronavirus disease 2019 (COVID-19) and is responsible for the ongoing pandemic affecting more than 210 countries. The virus has currently posed a global threat to the human population and demands the urgent need for sensitive and effective methods of diagnosis. Real-time reverse transcription polymerase chain reaction (RT-PCR) is currently used as a gold standard technique for detecting and quantifying the transcript of viral ribonucleic acid. Yet many factors are essential for successful COVID-19 diagnosis, including sample sources, amount of viral load, isolation of ribonucleic acid, and the selection of the molecular targets. Although broncho alveolar lavage fluid (BALF) and sputum sample contain a high viral load with a high diagnostic value, they cannot be collected from mild to asymptomatic cases, therefore nasopharyngeal swab is considered better and is collected in all cases that contain a viral load significantly, whereas the use of blood and faecal specimens needs further examination with respect to systemic infection and viral shedding. Furthermore, rapid diagnostic test, clustered regularly interspaced short palindromic repeats (CRISPR)-based testing, chest computerized tomography (CT) scans, matrix-assisted laser desorption/ionization mass spectrometry (MALDI-MS), reverse transcriptional loop-mediated isothermal amplification (LAMP), point of care (POC) testing and genexpert recently tool may help with COVID-19 diagnosis. In this review, we focus on diagnostic approaches for effective detection of SARS-CoV-2 infection. © 2020, Editorial board of Journal of Experimental Biology and Agricultural Sciences. All rights reserved.