THE LAW RELATING TO CLINICAL TRIALS IN INDIA: THE PREVAILING DEFICIENCIES AND THE ROAD AHEAD
Notice bibliographique
Résumé
Clinical trials stand at the crux of medical advancement, serving as the vital link between laboratory research and the availability of new treatments for patients’ ailments. In a world increasingly reliant on evidence-based medicine, the importance of rigorous, ethical, and well-regulated clinical trials cannot be overstated. However, the dynamic and multifaceted nature of clinical trials raises complex legal, ethical, and social issues, particularly in a diverse and populous nation like India. This book, “The Law Relating to Clinical Trials in India: The Prevailing Deficiencies and the Road Ahead,” by Ms. Gayathri N. M. and Ms. Nidhi R, provides a comprehensive analysis of India’s legal framework governing clinical trials. It assesses the current state of the law, identifies the deficiencies therein, and offers a thought-provoking exploration of the path to rectifying these shortcomings. The pages within unfold the historical tapestry of clinical trials, setting the stage with an exploration of their evolution both globally and within the Indian context. The book ventures into the intricate lattice of regulations and guidelines that govern clinical trials in India and juxtaposes them against the global standards set by more developed frameworks in the United States and Canada. Through the chapters, the reader is invited to examine the role of Indian courts in interpreting and applying the laws concerning clinical trials, often acting as bulwarks against unethical practices. The narrative further delves into the comparisons between regulatory systems, thereby drawing lessons from international best practices. Perhaps most critically, this work does not shy away from discussing the challenges and deficiencies that mar the current Indian clinical trial landscape. It ventures into the depths of the 2019 New Drugs and Clinical Trials Rules (NDCTR), unearthing its flaws and potential. The Covid-19 pandemic and the resultant vaccine fast approvals present a case study, highlighting the urgency for reform in the face of unprecedented global health challenges. As we reach the denouement in the concluding chapter, the authors synthesize their findings and articulate a series of well-reasoned suggestions. Their vision for the future of India’s clinical trial legal system is one of pragmatism and hope, guided by the twin stars of participant safety and scientific integrity. The preface serves as an invitation to readers — scholars, practitioners, policymakers, and anyone with an interest in the crossroads of law, medicine, and ethics — to embark on this intellectual journey. The goal is not only to inform but also to inspire action that will shape a more robust, just, and effective framework for clinical trials in India. In closing, this book aims to contribute meaningfully to the discourse on improving the regulatory environment for clinical trials in India, ensuring that the nation’s laws keep pace with scientific progress while safeguarding the rights and welfare of participants.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,031 | 0,010 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,001 | 0,004 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; les deux têtes enseignantes s’accordent sur ce qui est montré ici.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».