Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article, we share the experience of on-site monitoring of clinical trials by the Ethics Committee of a tertiary care, academic and research centre in India. We found a large number of shortcomings (...) in the areas of informed consent, adverse events, insurance and reimbursement, which would not have been detected by off-site document review. Interestingly, many shortcomings were also not detected by on-site monitoring arranged by clinical trial sponsors. We therefore conclude that on-site monitoring of ongoing clinical trials is a highly important activity for Indian Ethics Committees. (shrink)

This volume is a critical investigation into the contemporary phenomenon of the dissensus of the globe and the planet, and the new terrains of consciousness that need to be negotiated towards a possibility for transformation. It examines the possibilities of alternate, sustainable modes of being and existing in a world which requires a unified, ethical, biopolitical worldview. The book explores themes like philosophical posthumanism and planetary concerns; disruption of cultural and intellectual inequality; bodily movement through nomadic subjectivity; dystopic spatialities of (...) game(re)play; globalization, and speculative imaginaries of the body; and theory of multiplicity. It also discusses impact of COVID on human beings, role of the neoliberal media, the question of rights of robots and cyborgs in sci-fi movies, and representation of refugees in literature. This book will be of interest to scholars and researchers of English literature, political philosophy, cultural studies, literary cultures, post-colonial studies, critical theory, and social anthropology. (shrink)

This book presents a critical analysis of sense-making practices through an exploration of acoustic, creative, and artistic spaces. It studies how local cultures of sight, hearing, smell, taste, and touch are impacted by global discourses and media, such as television, popular music, digital media, and literature. The authors look at sense-making practices and spatial discourses through an interconnected discussion on thought and experience that seeks to present a multidimensional cartography of the global, the local, and the glocal, to closely analyze (...) the phenomenon of globalization. The volume is an investigation of the possibilities of alternate, sustainable modes of being and existing in a world which requires a unified, ethical, biopolitical worldview that challenges the disparity of its fragments while speculating on their synesthetic conditionality. A unique contribution, the book will be of interest to scholars and researchers of English literature, media studies, cultural studies, literary cultures, post-colonial studies, globalization studies, philosophy, critical theory, sociology, and social anthropology. (shrink)

Clinical Pharmacology is a specialty with many attributes and our association with the subject has allowed us to acquire, apply and disseminate myriad aspects of research and practice. Though clinical pharmacologists are conspicuous by virtue of their small number, recent years have shown a growing need for the course. In the review below we navigate through several aspects of the subject as we encountered them from time to time. From critical appraisal of literature, to application of knowledge of drugs, to (...) clinical practice; moving on to clinical and basic research, to drug development process, to policy making - these are but a few of the many fields which constitute the scope of clinical pharmacology. The importance of the subject lies in allowing a trainee to develop a broad overview of the entire process, from drug generation to drug distribution to drug utilization, a process meant for the greater common goal of better health for all. We foresee a bright future for the subject though with a slight skepticism thrown in. In the present article, we make use of personal experiences and reference from literature to help you get a broad view of what clinical pharmacology means to us. (shrink)