دورية أكاديمية
Compensation in Neonatal Clinical Trials: A Perspective.
| العنوان: | Compensation in Neonatal Clinical Trials: A Perspective. |
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| المؤلفون: | Mathur A; Division of Reproductive, Child Health and Nutrition, Indian Council of Medical Research (ICMR), New Delhi, India., Raja D; Division of Reproductive, Child Health and Nutrition, Indian Council of Medical Research (ICMR), New Delhi, India., Sinha A; Division of Reproductive, Child Health and Nutrition, Indian Council of Medical Research (ICMR), New Delhi, India. Correspondence to: Dr. Anju Sinha, ICMR Emeritus Scientist, Division of Reproductive, Child Health and Nutrition, Coordinator and PI MRC UKRI, ProSPoNS trial, Indian Council of Medical Research Head Quarters, Ansari Nagar, New Delhi, India. apradhandr@gmail.com., Gupta SS; Department of Community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences(MGIMS), Wardha, Maharashtra, India., Gupta YK; Principal Advisor India Strategy Development - Global Antibiotics Research and Development Partnership (GARDP), Pune, Maharashtra, India., Kawade AS; King Edwards Medical College, Pune, Maharashtra, India 5INCLEN Trust, New Delhi, India., Poluru R; INCLEN Trust, New Delhi, India. |
| مؤلفون مشاركون: | The ProSPoNS Trial Group |
| المصدر: | Indian pediatrics [Indian Pediatr] 2024 May 15; Vol. 61 (5), pp. 469-474. Date of Electronic Publication: 2024 Mar 19. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Indian Pediatrics Country of Publication: India NLM ID: 2985062R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 0974-7559 (Electronic) Linking ISSN: 00196061 NLM ISO Abbreviation: Indian Pediatr Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: New Delhi : Indian Pediatrics Original Publication: Bombay. |
| مواضيع طبية MeSH: | Clinical Trials as Topic*, Humans ; Infant, Newborn ; India ; Compensation and Redress/legislation & jurisprudence |
| مستخلص: | Well conducted clinical trials are the mainstay for generating evidence on preferred treatments. In order to adequately protect the interests of the trial participants, the Central Licensing Authority of India has formulated guidelines to determine the quantum of compensation in cases of regulatory clinical trial related injury or death. However, these guidelines do not address the nuances of trials recruiting children aged under 16 years, within which, neonates are the most vulnerable population. Thus, there is a need for addressing this lacuna in the current guidelines. This article examines the challenges in determining the quantum of compensation in neonatal clinical trials using the current formula, which is a corollary to the challenges faced by the authors in procuring clinical trial insurance for the Probiotic supplementation for Prevention of Neonatal Sepsis (ProSPoNS) trial. Further, it suggests a template for a differential formula using birthweight of infants, which is one of the many important factors impacting neonatal mortality. |
| تواريخ الأحداث: | Date Created: 20240322 Date Completed: 20240513 Latest Revision: 20240513 |
| رمز التحديث: | 20240513 |
| PMID: | 38517006 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 0974-7559 |
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