UrmilaM Thatte
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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: Recruitment and retention of the participants in clinical trials: Challenges and solutions
Recruitment and retention of the participants in clinical trials: Challenges and solutions Open
Drug development is a tedious and expensive procedure and it takes roughly 10 to 15 years to take a potential treatment from bench to bedside and costs the pharmaceutical companies as much as USD ~2 billion for the process. Delay in invest…
View article: Factors influencing recruitment and retention of participants in clinical studies conducted at a tertiary referral center: A five-year audit
Factors influencing recruitment and retention of participants in clinical studies conducted at a tertiary referral center: A five-year audit Open
Introduction: A key determinant of the success of any study is the recruitment and subsequent retention of participants. Screen failure and dropouts impact both the scientific validity and financial viability of any study. We carried out t…
View article: An audit of reporting of conflict of interest policies among three stakeholders in Indian biomedical journals
An audit of reporting of conflict of interest policies among three stakeholders in Indian biomedical journals Open
Very few Indian biomedical journals have COI policies for reviewers and editors and most did not explain it adequately. Nearly, a fifth of the journals we evaluated did not follow any guideline for disclosing COI.
View article: A comparative study to evaluate quality of data documentation between investigator-initiated and pharmaceutical industry-sponsored studies
A comparative study to evaluate quality of data documentation between investigator-initiated and pharmaceutical industry-sponsored studies Open
Quality of IIS needs to be addressed by greater oversight and periodic quality control assessments.
View article: Current status of standardized, quality and ethical oversight of clinical research in the country: An audit of the Central Drugs Standard Control Organization (registration of ethics committees) and national accreditation board for hospital and healthcare providers (accreditation) databases
Current status of standardized, quality and ethical oversight of clinical research in the country: An audit of the Central Drugs Standard Control Organization (registration of ethics committees) and national accreditation board for hospital and healthcare providers (accreditation) databases Open
Registration and reregistration of ECs along with accreditation is not commensurate with the needs of the country at this time and must be vigorously promoted.
View article: Payment for participation in clinical research: Review of proposals submitted to the ethics committees
Payment for participation in clinical research: Review of proposals submitted to the ethics committees Open
The present study first of its kind in India, demonstrated that quantum of payment was not uniform for pharmaceutical sponsored and investigator initiated studies and payments were not considered for majority of observational studies. Trav…
View article: Investigator preparedness for monitoring and audits
Investigator preparedness for monitoring and audits Open
Monitoring and audits are two distinct processes that ensure that the rights and safety of the participants are protected, and data integrity is maintained. The present narrative summates authors' experiences with monitoring and audits by …
View article: Audiovisual recording of the consenting process in clinical research: Experiences from a tertiary referral center
Audiovisual recording of the consenting process in clinical research: Experiences from a tertiary referral center Open
The quality of the written informed consent process is one of the most important aspects of clinical research, as it is the single tool that serves as a metric of autonomy. Several challenges have been identified with the informed consent …
View article: Do clinical trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India
Do clinical trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India Open
Background: India continues to contribute disproportionately to the global burden of disease and public health research output from India is also known to be not commensurate with her healthcare needs. We carried out the present study to a…
View article: A study comparing trial registry entries of randomized controlled trials with publications of their results in a high impact factor journal: The Journal of the American Medical Association
A study comparing trial registry entries of randomized controlled trials with publications of their results in a high impact factor journal: The Journal of the American Medical Association Open
Purpose: The International Committee of Medical Journal Editors mandates trial registration as a precondition for publication. Growing evidence indicates that information in registry may not correlate with eventual publication. The present…
View article: Valbenazine: Drug review
Valbenazine: Drug review Open
Valbenazine is the first drug approved by the US Food and Drug Administration for the treatment of adults with tardive dyskinesia (TD) on April 11, 2017. It acts as a reversible inhibitor of vesicular monoamine transporter 2. It is availab…
View article: Ethics Committees in India: Past, present and future
Ethics Committees in India: Past, present and future Open
Although ECs in India have evolved from being mere rubber stamps for approval of protocols to efficiently functioning accredited ECs, yet there is much to be done for and by Ethics Committees.
View article: Regulatory requirements for clinical trials in India: What academicians need to know
Regulatory requirements for clinical trials in India: What academicians need to know Open
The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research. Of these, research, though long and difficult, is extrem…
View article: Evaluation of cytochrome P4502E1 polymorphisms in healthy adult Western Indians and patients with antituberculous drug-induced hepatotoxicity
Evaluation of cytochrome P4502E1 polymorphisms in healthy adult Western Indians and patients with antituberculous drug-induced hepatotoxicity Open
A background prevalence of CYP2E1*B polymorphism and their activity in Western Indian population was observed. The study suggests no association between the CYP2E1 genotyping with antituberculous drug-induced hepatotoxicity.
View article: Evaluation of CYP2C19, P2Y12, and ABCB1 polymorphisms and phenotypic response to clopidogrel in healthy Indian adults
Evaluation of CYP2C19, P2Y12, and ABCB1 polymorphisms and phenotypic response to clopidogrel in healthy Indian adults Open
A trend of decrease in the IPA with CYP2C19 genotypes and an increase in the same with the H2 haplotype of P2Y12 following clopidogrel in Indian healthy adults were observed. Assessment of genetic polymorphisms of the same may aid in perso…
View article: An audit of the approval letters issued by Drugs Controller General of India to Ethics Committees in India
An audit of the approval letters issued by Drugs Controller General of India to Ethics Committees in India Open
The office of the DCGI had a very wide time range for approving registration of Ethics Committees that ranged from less than a month to more than two years. The quality and nature of the directives improved with time. As the country moves …
View article: Evaluation of pharmacokinetics of single-dose chloroquine in malnourished children with malaria- a comparative study with normally nourished children
Evaluation of pharmacokinetics of single-dose chloroquine in malnourished children with malaria- a comparative study with normally nourished children Open
Our results indicate that dosage requirement is unlikely to be needed for chloroquine in undernourished children with uncomplicated P. vivax malaria.