Vishal Kumar Biswkarma

Abstract

Context: After China, now COVID-19 is spreading all over the world in about 212 countries and territories. In India, over 46008 active, 22454 recovered, 2293 death, and 1 migrated case (a total of 70756 cases) has been reported till 12th May 2020. Aims: This study has been designed to review the currently registered clinical studies in Clinical Trials Registry-India. The study provides the overall summary and insight into diagnostic tools, treatment, and preventive strategies for COVID-19. Settings and Design: All the clinical trials (including clinical studies) registered in Clinical Trials Registry-India between 31 March 2020 to 11th May 2020 were reviewed and analyzed. Materials and Methods: The registered studies in CTRI (ctri.nic.in) were searched in the “Trial Search” option with keywords such as “COVID-19”, “Corona Virus”, “SARS-CoV2”, and “2019 nCoV”. Statistical analysis used: NA. Results: A total of 57 trials over COVID-19 have been registered in CTRI within the last three months (i.e. 1st March 2020 to 11th May 2020). These trials include 40 interventional trials and 17 clinical studies. The interventional studies include the drug, biologics, ayurvedic, homeopathic, diagnostic, nutritional, and process of care change. Conclusions: The world is combating against the COVID-19 outbreak. The availability of new health intervention against COVID-19 needs the more scientific, and collaborative center of attention towards drug development and clinical trials for COVID-19. Key Messages: The fast track approval of clinical trials, effective study design, making informed consent more “inform”, planning and scientific consideration over sample size, development of data safety monitoring board to supervise and ensure trial participant’s safety may enforce the successfulness of trial completion. Keywords: Clinical Trial Registry India, COVID19, Clinical trials, Interventional studies, Observational studies

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Abstract

The expenses of health services are expanding in all the nations as the enhancement in and alteration of wellbeing advances every day. Pharmacoeconomics evaluation of clinical trials plays a vital role in assisting clinicians and researchers to take the decision over the economic and clinical outcomes of new health intervention and in helping patients to access new health interventions in affordable expenses. Incorporating pharmacoeconomics into clinical trials offers a clinical research organization to developed, design, and conduct a clinical trial to gain the most reliable data with possible minimum expenses. A literature search was done using Medline electronic database with PubMed. MeSH terms such as ‘Pharmacoeconomics’, Cost-effectiveness Analysis’, ‘Cost-minimization Analysis’, ‘Cost-utility Analysis’, ‘Cost-benefit Analysis’, ‘Health economics’, ‘Quality of Life’, ‘Cost-analysis’, ‘Clinical trials’, ‘Healthcare’ etc. were used. We found that most randomized clinical trials have been assessed for economic evaluation. Pharmacoeconomics data generated from clinical trials gives insight to researchers and industries to estimate the economic burden of trials, decide to provide reimbursement to participants, and allocating funds to clinical trial/health research. Key Messages: The economic assessments of trials offer health organizations to decide policymaking and providing health insurance whereas regulatory bodies over approval and pricing of new health intervention. The researchers need to develop, design, and conduct an economic assessment of the initial phase of clinical trials which provide the basis to conduct an economic evaluation for further trial development phases. Keywords: Clinical trials, Pharmacoeconomics evaluation, Randomized clinical trial, Emerging, Cost-effectiveness analysis.

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