Complexity of clinical trial operationalisation in India

Shivabasappa, Santhosh; Srinivasan, Akila

doi:10.1016/s2214-109x(22)00209-1

Cited by 2 publications

(1 citation statement)

References 3 publications

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“…Trials are often portrayed as commercial activity by the media instead of a scientific endeavor to answer public health questions. [ 26 ] The dip in the number of Phase 1 trials in India in 2013 coincided with the overall reduction in the number of clinical trials. This is believed to have been as a result of regulatory reforms linked to hearings of a public interest litigation by the Supreme Court of India concerning clinical trials.…”

Section: Discussionmentioning

confidence: 99%

A review of clinical trials registered in India from 2008 to 2022 to describe the first-in-human trials

Sabu,

Venkatraman,

Cherian

et al. 2023

Perspectives in Clinical Research

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Aim: This analysis was conducted to review the number, and describe the characteristics of first-in-human (FIH) Phase 1 clinical trials registered in India from 2008 to 2022. Materials and Methods: The data were extracted from the Clinical Trials Registry – India database for all FIH Phase 1 clinical trials registered between 2008 and 2022. Early-phase trials that were not FIH trials (e.g., pharmacokinetic studies and drug–drug interaction studies) were excluded from the study. Results: A total of 1891 trials were retrieved and 220 were included in the analysis. Most of the investigational products were drugs (55%) followed by vaccines (38.2%). The most common therapeutic class of drugs was cancer chemotherapy (19.8%), followed by antimicrobial chemotherapy and endocrinology (18.2% each). The most common vaccine was the influenza vaccine (21.4%), followed by the measles–mumps–rubella vaccine (15.5%). The pharmaceutical industry was the predominant sponsor for most (91%) of the Phase 1 trials. Of the top five sites where most of the Phase 1 trials were conducted, three were private nonacademic centers (cumulatively 31%) and two were tertiary care medical colleges (cumulatively 9%). Conclusion: Phase 1 clinical trials seem to be conducted in India predominantly with industry sponsorship. There is a need to have an alternate ecosystem to take forward molecules that do not receive adequate attention from the industry and molecules that are of national health priority other than areas such as chemotherapy, antimicrobials, and endocrinology. The Indian Council of Medical Research is setting up Phase 1 clinical trial capacity for molecules that predominantly may arise from nonindustry channels.

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Section: Discussionmentioning

confidence: 99%

A review of clinical trials registered in India from 2008 to 2022 to describe the first-in-human trials

Sabu,

Venkatraman,

Cherian

et al. 2023

Perspectives in Clinical Research

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Digital physiotherapy intervention in children in a low resource setting in Anantapur (India): Study protocol for a randomized controlled trial

Estebanez-Pérez

Martín-Valero

Morales

et al. 2022

Front. Public Health

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IntroductionIn rural India the scarcity of physiotherapists and inequalities complicate the recovery of traumatized children. This study protocol will explore a digital physiotherapy intervention in children with ankle fracture in a low-resource setting to improve functional independence and quality of life.Methods and analysisA randomized clinical trial with a mixed quantitative-qualitative design will be carried out. It is a single-blind study, where the evaluator does not know the nature of the intervention. Sixty subjects will be enrolled and randomly divided into two groups: the experimental group (EG) will receive a 4-week digital physiotherapy intervention through an app in a recycled mobile device after hospital discharge; the control group (CG) will receive the physiotherapy standard care recommended for patients discharged from the hospital. Subjects will receive a baseline (T0-pre) assessment of Functional Independence and Quality of Life. At the end of the 4-week intervention (T1-post) a new assessment of the outcome will be performed adding data on adherence, satisfaction (ad hoc questionnaire and TSQ), and barriers of use. Qualitative outcomes will also be explored. The author's hypothesized that the implementation of a digital physiotherapy intervention is feasible and effective to improve functional independence and quality of life. This study protocol is the first to explore the effect of digital physiotherapy intervention in children's patients in a low resource setting (Anantapur).DiscussionThe successful delivery of the intervention, an optimal adherence records, the absence of significant adverse effects, user satisfaction level and the qualitative analysis of limitations, will demonstrate the effectiveness of these procedure. This study will add more evidence in support the use of digital physiotherapy practice as an effective tool. User particularities, provider's capacity, technological and cultural limitations, and considerations for vulnerable populations will be taken into account.Clinical trial registrationNCT04946695 (https://clinicaltrials.gov/).

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Complexity of clinical trial operationalisation in India

Cited by 2 publications

References 3 publications

A review of clinical trials registered in India from 2008 to 2022 to describe the first-in-human trials

A review of clinical trials registered in India from 2008 to 2022 to describe the first-in-human trials

Digital physiotherapy intervention in children in a low resource setting in Anantapur (India): Study protocol for a randomized controlled trial

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