Nithya Gogtay
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View article: Status of registration, re-registration, and accreditation of ethics committees with Central Drugs Standard Control Organization, Department of Health Research, and National Accreditation Board for Hospitals and Healthcare Providers – An evaluation of the extent of ethics oversight in the country
Status of registration, re-registration, and accreditation of ethics committees with Central Drugs Standard Control Organization, Department of Health Research, and National Accreditation Board for Hospitals and Healthcare Providers – An evaluation of the extent of ethics oversight in the country Open
Context: The “New Drugs and Clinical Trials Rules 2019” mandates that Ethics Committees (ECs) register with the Central Drugs Standard Control Organization (CDSCO), while ECs overseeing Postgraduate (PG) theses and academic studies must re…
View article: Comparison of pre-COVID-19 pandemic, lockdown, and postlockdown participant adherence in a phase IV clinical trial for the treatment of postexposure rabies prophylaxis
Comparison of pre-COVID-19 pandemic, lockdown, and postlockdown participant adherence in a phase IV clinical trial for the treatment of postexposure rabies prophylaxis Open
Context: One of the most frequent difficulties encountered in clinical trials is the failure to retain participants and this is doubly important when the disease is 100% fatal. Studies conducted during the COVID-19 pandemic regarding adher…
View article: Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults
Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults Open
AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxfor…
View article: Authors’ reply
Authors’ reply Open
View article: Economic burden of beta-thalassaemia major receiving hypertransfusion therapy at a public hospital in Mumbai
Economic burden of beta-thalassaemia major receiving hypertransfusion therapy at a public hospital in Mumbai Open
Background Treating beta-thalassaemia major may entail high costs with considerable out-of-pocket expenditure. Therefore, determination and valuation of the economic costs of a common haemoglobinopathy such as beta-thalassaemia major in In…
View article: A prospective study to assess the role of paraoxonase 1 genotype and phenotype on the lipid-lowering and antioxidant activity of statins
A prospective study to assess the role of paraoxonase 1 genotype and phenotype on the lipid-lowering and antioxidant activity of statins Open
Human paraoxonase 1 (PON1) enzyme protects against atherosclerosis by preventing low-density lipoprotein from oxidative modification. Upregulation of PON1 enzymatic activity is suggested to contribute to atheroprotective potential of stati…
View article: Efficacy and safety of AP-Bio®(KalmCold®) in participants with uncomplicated upper respiratory tract viral infection (common cold) − A phase III, double-blind, parallel group, randomized placebo-controlled trial
Efficacy and safety of AP-Bio®(KalmCold®) in participants with uncomplicated upper respiratory tract viral infection (common cold) − A phase III, double-blind, parallel group, randomized placebo-controlled trial Open
Participants in both the AP-Bio® dose groups showed positive tendency towards resolution of URTI symptoms when compared with placebo on Day-3 but not on Day-5 and Day-7.
View article: Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study
Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study Open
SIIPL, Indian Council of Medical Research, Novavax.
View article: Evaluation of satisfaction and reasons for participation in a Covid-19 vaccine clinical trial: A single-centre, observational study
Evaluation of satisfaction and reasons for participation in a Covid-19 vaccine clinical trial: A single-centre, observational study Open
Background In May 2020, WHO recognized the role of extensive immunization for interrupting the transmission of the SARS-CoV-2 virus. The development of such vaccines in clinical trials relies upon participants who are expected to be vested…
View article: An audit of institutional ethics committee queries raised after initial project submission by a single research department at a tertiary referral center in India
An audit of institutional ethics committee queries raised after initial project submission by a single research department at a tertiary referral center in India Open
Introduction: The institutional ethics committees (IECs) raise queries following protocol reviews. The quality of these queries would be a useful metric to assess how well the IEC executes its fundamental role of protecting participants. M…
View article: Population Pharmacokinetics of Hydroxychloroquine Sulfate in Healthcare Workers, Given for Prophylaxis Against Coronavirus Disease 2019 (COVID‐19) in India
Population Pharmacokinetics of Hydroxychloroquine Sulfate in Healthcare Workers, Given for Prophylaxis Against Coronavirus Disease 2019 (COVID‐19) in India Open
Healthcare workers (HCWs) and frontline workers were recommended hydroxychloroquine (HCQ) 400 mg twice a day on day 1, followed by 400 mg once weekly for the next 7 weeks, as prophylaxis against COVID‐19. There was limited information on t…
View article: Research, residents, and registrars – getting it right
Research, residents, and registrars – getting it right Open
View article: An evaluation of the minutes of subject expert committee meetings of novel COVID-19 proposals
An evaluation of the minutes of subject expert committee meetings of novel COVID-19 proposals Open
View article: Safety and Immunogenicity of SII-NVX-CoV2373 (COVID-19 Vaccine) In Adults in a Phase 2/3, Observer-Blind, Randomised, Controlled Study
Safety and Immunogenicity of SII-NVX-CoV2373 (COVID-19 Vaccine) In Adults in a Phase 2/3, Observer-Blind, Randomised, Controlled Study Open
View article: An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period
An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period Open
The present audit was carried out with the objective of evaluating warning letters (WLs) issued to trial sponsors, clinical investigators and institutional review boards (IRBs) by the United States Food and Drug Administration during a six…
View article: A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India
A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India Open
View article: An analysis of invitations for article submission received via emails
An analysis of invitations for article submission received via emails Open
Predatory journals charge publication fees from authors and publish without an adequate peer review, and often do not provide editorial and/or publishing services. Our objective was to evaluate e-mail solicitations received by authors in a…
View article: Placing the results of the SOLIDARITY trial with regards to remdesivir in perspective
Placing the results of the SOLIDARITY trial with regards to remdesivir in perspective Open
Remdesivir, a repurposed antiviral, was first accorded approval by the US Food Drug Administration (FDA) for the treatment of COVID-19 which necessitates hospitalization. However, the interim data of SOLIDARITY trial revealed no benefits w…
View article: Compliance of Mumbai-based clinical trial sites with the Quality Council of India guidelines and evaluation of the challenges faced by the investigators
Compliance of Mumbai-based clinical trial sites with the Quality Council of India guidelines and evaluation of the challenges faced by the investigators Open
Purpose: A committee chaired by Dr. Ranjit Roy Chaudhary suggested accreditation of investigators, sites and ethics committees to improve the quality of trial conduct in the country. Prior to accreditation, understanding the challenges fac…
View article: An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies
An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies Open
Background: The approval process of every drug regulatory agency differs, and hence, the time required for the approval of a new drug varies. This results in a drug lag and India is no exception to this phenomenon. A drug lag precludes Ind…
View article: Has mandatory prospective registration of all studies brought about a change? A 1-year audit of studies registered in the Clinical Trials Registry of India [CTRI] before and after April 1, 2018
Has mandatory prospective registration of all studies brought about a change? A 1-year audit of studies registered in the Clinical Trials Registry of India [CTRI] before and after April 1, 2018 Open
Introduction: The Clinical Trials Registry of India (CTRI) that initially permitted retrospective registration moved to mandatory prospective registration of studies with effect from April 1, 2018. The present study was an audit that compa…
View article: Evaluation of vanillin as a probe drug for aldehyde oxidase and phenotyping for its activity in a Western Indian Cohort
Evaluation of vanillin as a probe drug for aldehyde oxidase and phenotyping for its activity in a Western Indian Cohort Open
Data of the phenotyping study suggest the existence of AO polymorphism, in a Western Indian cohort.
View article: A survey of knowledge and variables influencing perceptions about clinical research
A survey of knowledge and variables influencing perceptions about clinical research Open
Purpose: Clinical research in India has been besieged by controversies. While studies have addressed other stakeholders, few have addressed the patient. The present study was conducted to assess the extent of awareness and understanding ab…
View article: Prediction of Area Under the Curve of Vancomycin in Infants: A Comparison of Two Methods
Prediction of Area Under the Curve of Vancomycin in Infants: A Comparison of Two Methods Open
View article: Cytochrome P<sub>450</sub>2D6 polymorphism in eastern Indian population
Cytochrome P<sub>450</sub>2D6 polymorphism in eastern Indian population Open
Differences in CYP2D6 activity has treatment implications and may lead to adverse events or therapeutic failure. Phenotyping of subjects receiving CYP2D6 metabolized drugs may help clinicians personalize treatment and avert adverse drug-dr…
View article: The global initiative for asthma guidelines (2019): change in the recommendation for the management of mild asthma based on the SYGMA-2 trial – A critical appraisal
The global initiative for asthma guidelines (2019): change in the recommendation for the management of mild asthma based on the SYGMA-2 trial – A critical appraisal Open
The Global Initiative for Asthma (GINA) recently released their updated Global Strategy for Asthma Management and Prevention Guide (2019). The pocket guide for practicing clinicians states that "the 2019 GINA strategy report represents the…
View article: An Introduction to Statistics – Data Types, Distributions and Summarizing Data
An Introduction to Statistics – Data Types, Distributions and Summarizing Data Open
Ranganathan P, Gogtay NJ, An Introduction to Statistics - Data Types, Distributions and Summarizing Data. Indian J Crit Care Med 2019;23(Suppl 2):S169-S170.
View article: Immunogenicity and safety of an intramuscular split-virion quadrivalent inactivated influenza vaccine in individuals aged ≥ 6 months in India
Immunogenicity and safety of an intramuscular split-virion quadrivalent inactivated influenza vaccine in individuals aged ≥ 6 months in India Open
A quadrivalent split-virion inactivated influenza vaccine (IIV4; Fluzone® Quadrivalent, Sanofi Pasteur) has been available in the US since 2013 for individuals aged ≥ 6 months. Here, we describe the results of an open-label, multicenter tr…
View article: Ethics in competitive research
Ethics in competitive research Open
View article: Single-dose and Steady-state Pharmacokinetics of Vancomycin in Critically Ill Patients Admitted to Medical Intensive Care Unit of India
Single-dose and Steady-state Pharmacokinetics of Vancomycin in Critically Ill Patients Admitted to Medical Intensive Care Unit of India Open
Mali NB, Deshpande SP, Wandalkar PP, Gupta VA, Karnik ND, Gogtay NJ, et al. Single-dose and Steady-state Pharmacokinetics of Vancomycin in Critically Ill Patients Admitted to Medical Intensive Care Unit of India. IJCCM 2019;23(11):5…