Yashoda Aithal
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View article: Assessing knowledge, attitude, and practice of adaptive designs in clinical trials among Indian stakeholders
Assessing knowledge, attitude, and practice of adaptive designs in clinical trials among Indian stakeholders Open
Background: This study attempted to evaluate the knowledge, attitudes, and practices of various stakeholders addressing adaptive clinical trials (ACT), as no analogous studies have been published in India. Methods: Ethics committee (EC) ap…
View article: Onsite serious adverse events reporting: Seven-year experience of the institutional ethics committee of a tertiary care hospital
Onsite serious adverse events reporting: Seven-year experience of the institutional ethics committee of a tertiary care hospital Open
Background: Over the years, Indian regulations have undergone numerous amendments, including stringent reporting deadlines, relatedness requirements, and compensation obligations for serious adverse event (SAE). A historic change, new drug…
View article: Academic Clinical Trials Submitted to an Institutional Ethics Committee at a Tertiary Care Center: A Retrospective Analysis
Academic Clinical Trials Submitted to an Institutional Ethics Committee at a Tertiary Care Center: A Retrospective Analysis Open
Background The role of academia in clinical research has given rise to the concept of academic clinical trials (ACTs), which are vital in generating evidence. Through the implementation of the New Drugs and Clinical Trials Rules-2019 (NDCT…
View article: Assessment of the Need for Training in Clinical Pharmacology Research on Traditional Medicine among Modern Medicine Practitioners: A Questionnaire-based Study
Assessment of the Need for Training in Clinical Pharmacology Research on Traditional Medicine among Modern Medicine Practitioners: A Questionnaire-based Study Open
Introduction: Training young doctors is essential for carrying out need-based research. The field of Traditional Medicine (TM) has made significant contributions to modern medicine, and there is unlimited scope for exploring it further in …
View article: Onsite Serious Adverse Events Reporting: A Seven Year Experience of Institutional Ethics Committee of a tertiary care hospital.
Onsite Serious Adverse Events Reporting: A Seven Year Experience of Institutional Ethics Committee of a tertiary care hospital. Open
Aims: Over the years, Indian regulations have undergone numerous amendments including stringent reporting deadlines, relatedness requirements, and compensation obligations for Serious Adverse Event (SAE). A historic change, New drugs and t…