Pub Date : 2024-10-01Epub Date: 2024-08-30DOI: 10.4103/picr.picr_59_24
Abissha Sargunaraj, Jerin James, P Kala, R Jamuna Rani
{"title":"Changing landscape of geriatric clinical trials: Analysis of Clinical Trials Registry of India.","authors":"Abissha Sargunaraj, Jerin James, P Kala, R Jamuna Rani","doi":"10.4103/picr.picr_59_24","DOIUrl":"10.4103/picr.picr_59_24","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"15 4","pages":"215-216"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11584156/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142710893","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-10-09DOI: 10.4103/picr.picr_160_24
Vishal Deo, Priya Ranganathan
Previous articles in this series have looked at various aspects of planning, designing, conducting and interpreting biomedical research. In this article, we offer an overview of some tools and resources available to health and biomedical researchers, to help them with their research.
{"title":"Statistical tools and packages for data collection, management, and analysis - A brief guide for health and biomedical researchers.","authors":"Vishal Deo, Priya Ranganathan","doi":"10.4103/picr.picr_160_24","DOIUrl":"10.4103/picr.picr_160_24","url":null,"abstract":"<p><p>Previous articles in this series have looked at various aspects of planning, designing, conducting and interpreting biomedical research. In this article, we offer an overview of some tools and resources available to health and biomedical researchers, to help them with their research.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"15 4","pages":"209-212"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11584161/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142710896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Purpose: To conduct a network meta-analysis comparing the safety and efficacy of gabapentin (GBP), pregabalin (PGB), oxcarbazepine (OXC), and duloxetine (DLX) in treating diabetic peripheral neuropathy (DPN).
Materials and methods: The study's eligibility criteria includee randomized controlled trials (RCTs) with a focus on DPN patients receiving GBP, PGB, DLX, or OXC versus placebo. Noncompliant trials with incomplete information and observational studies were excluded.
Results: Twelve (RCTs) of PGB, 2 of GBP, 3 of DLX, and 1 of OXC met the inclusion criteria. When drugs were compared for efficacy (direct comparison), GBP (Odd's ratio [OR] = 3.208, P < 0.001) was most effective followed by OXC (OR = 2.4, P = 0.0248), DLX (OR = 2.346, P < 0.001), and PGB (OR = 2.161, P < 0.001). When drugs were compared for withdrawal due to adverse drug reaction (ADR) (direct comparison), GBP (OR = 1.3818, P = 0.766) was safest followed by PGB (OR = 2.16, P < 0.001), DLX (OR = 2.469, P < 0.001), and OXC (OR = 4.4967, P = 0.001). Indirect comparison was done for efficacy, DLX was statistically significant than PGB and OXC (DLX vs. PGB, P = 0.03; DLX vs. OXC, P = 0.02). When indirect comparison was done for patient withdrawal due to ADR, OXC was worst (GBP vs. OXC, P = 0.0001; PGB vs. OXC, P = 0.007; DLX vs. OXC, P = 0.015). When drugs were compared for individual ADRs (direct comparison), dizziness was most commonly seen with OXC (OR = 9.6535, P = 1.8425), headache with OXC (OR = 3.8686, P = 0.006), somnolence with PGB (OR = 5.189, P < 0.001), and nausea with DLX (OR = 3.264, P < 0.001). GBP was most effective and safest drug followed by OXC > DLX > PGB for efficacy and PGB > DLX > OXC for safety.
Conclusion: In evaluating medications for DPN against placebo, GBP and OXC demonstrated the highest effectiveness while maintaining a favorable safety profile.
{"title":"Comparative efficacy and safety of gabapentin, pregabalin, oxcarbazepine, and duloxetine in diabetic peripheral neuropathy: A network meta-analysis.","authors":"Karan Bhavesh Shah, Devang A Rana, Yash Dharmendra Mehta, Supriya Deepak Malhotra","doi":"10.4103/picr.picr_218_23","DOIUrl":"10.4103/picr.picr_218_23","url":null,"abstract":"<p><strong>Purpose: </strong>To conduct a network meta-analysis comparing the safety and efficacy of gabapentin (GBP), pregabalin (PGB), oxcarbazepine (OXC), and duloxetine (DLX) in treating diabetic peripheral neuropathy (DPN).</p><p><strong>Materials and methods: </strong>The study's eligibility criteria includee randomized controlled trials (RCTs) with a focus on DPN patients receiving GBP, PGB, DLX, or OXC versus placebo. Noncompliant trials with incomplete information and observational studies were excluded.</p><p><strong>Results: </strong>Twelve (RCTs) of PGB, 2 of GBP, 3 of DLX, and 1 of OXC met the inclusion criteria. When drugs were compared for efficacy (direct comparison), GBP (Odd's ratio [OR] = 3.208, <i>P</i> < 0.001) was most effective followed by OXC (OR = 2.4, <i>P</i> = 0.0248), DLX (OR = 2.346, <i>P</i> < 0.001), and PGB (OR = 2.161, <i>P</i> < 0.001). When drugs were compared for withdrawal due to adverse <i>drug</i> reaction (ADR) (direct comparison), GBP (OR = 1.3818, <i>P</i> = 0.766) was safest followed by PGB (OR = 2.16, <i>P</i> < 0.001), DLX (OR = 2.469, <i>P</i> < 0.001), and OXC (OR = 4.4967, <i>P</i> = 0.001). Indirect comparison was done for efficacy, DLX was statistically significant than PGB and OXC (DLX vs. PGB, <i>P</i> = 0.03; DLX vs. OXC, <i>P</i> = 0.02). When indirect comparison was done for patient withdrawal due to ADR, OXC was worst (GBP vs. OXC, <i>P</i> = 0.0001; PGB vs. OXC, <i>P</i> = 0.007; DLX vs. OXC, <i>P</i> = 0.015). When drugs were compared for individual ADRs (direct comparison), dizziness was most commonly seen with OXC (OR = 9.6535, <i>P</i> = 1.8425), headache with OXC (OR = 3.8686, <i>P</i> = 0.006), somnolence with PGB (OR = 5.189, <i>P</i> < 0.001), and nausea with DLX (OR = 3.264, <i>P</i> < 0.001). GBP was most effective and safest drug followed by OXC > DLX > PGB for efficacy and PGB > DLX > OXC for safety.</p><p><strong>Conclusion: </strong>In evaluating medications for DPN against placebo, GBP and OXC demonstrated the highest effectiveness while maintaining a favorable safety profile.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"15 4","pages":"202-208"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11584157/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142710895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Evaluation of student-led “Association for Support and Propagation of Innovation, Research, and Education” (A.S.P.I.R.E) in empowering undergraduate medical students in research: A 2-year longitudinal study","authors":"Shirish Rao, Yashika Yagade, Amey Ambike, Aarya Desai, Amey Kundawar, Alhad Mulkalwar, Munira Hirkani, Raakhi Tripathi","doi":"10.4103/picr.picr_25_24","DOIUrl":"https://doi.org/10.4103/picr.picr_25_24","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":" 669","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141823787","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-10DOI: 10.4103/picr.picr_305_23
Vijeta Bajpai, Tejas K. Patel, Priyanka Dwivedi, Ankita Kabi, Yashpal Singh, Richa Agarwal, Ravi Gupta, Surekha Kishore
The present study aimed to compare the efficacy, safety, and cost-effectiveness of quick penetrating solution (QPS) heparin, QPS diclofenac, and heparin gel in the prevention of superficial thrombophlebitis (ST). This randomized controlled trial was conducted after approval from the Institutional Ethics Committee and registration to Clinical Trial Registry of India. Patients of 18–60 years age, American Society of Anesthesiologists I/II, and who needed venous cannulation for at least 72 h were included in the study. Patients were randomly divided into three groups receiving study drugs (heparin gel, QPS heparin, and QPS diclofenac) every 8 hourly for a period of 72 h. Venous cannulation site was graded using the Visual Infusion Phlebitis Scale. Patients developing no ST, mean time to reach ST Grade 1 and 2, prevention of ST probability, and cost-effectiveness of interventions during the study period were assessed. Out of 219 included patients, development of no ST in the study groups at 72 h of treatment were heparin gel (11%), QPS heparin (9.6%), and QPS diclofenac (2.7%). The mean time (hours) to develop any grade ST in the study arms was heparin gel (36.2 [11.9]), QPS heparin (40.0 [13.4]), and QPS diclofenac (37.0 [13.2]). The Kaplan–Meier analysis did not reveal significant differences for the prevention of any grade ST or severe ST in three treatment arms. The average cost-effectiveness ratio for preventing thrombophlebitis was 14.2 in heparin gel-, 13.2 in QPS heparin-, and 95.6 in QPS diclofenac-treated patients. Based on efficacy, safety, and cost-effectiveness, heparin gel or QPS heparin can be used to prevent ST due to intravenous cannulation in surgical patients. QPS diclofenac is not a cost-effective option to prevent ST.
本研究旨在比较肝素快速渗透溶液（QPS）、肝素快速渗透溶液双氯芬酸和肝素凝胶在预防浅表血栓性静脉炎（ST）方面的疗效、安全性和成本效益。 这项随机对照试验是在获得机构伦理委员会批准并在印度临床试验登记处登记后进行的。研究对象包括年龄在 18-60 岁之间、美国麻醉医师协会 I/II 级、需要静脉插管至少 72 小时的患者。患者被随机分为三组，在 72 小时内每 8 小时接受一次研究药物（肝素凝胶、QPS 肝素和 QPS 双氯芬酸）。对研究期间未发生 ST 的患者、达到 ST 1 级和 2 级的平均时间、ST 概率的预防以及干预措施的成本效益进行了评估。 在纳入的 219 名患者中，治疗 72 小时后未出现 ST 的研究组分别为肝素凝胶组（11%）、QPS 肝素组（9.6%）和 QPS 双氯芬酸组（2.7%）。肝素凝胶（36.2 [11.9]）、QPS 肝素（40.0 [13.4]）和 QPS 双氯芬酸（37.0 [13.2]）治疗组出现任何等级 ST 的平均时间（小时）为 36.2 [11.9]，QPS 肝素（40.0 [13.4]）和 QPS 双氯芬酸（37.0 [13.2]）。卡普兰-梅耶分析显示，三种治疗组在预防任何等级 ST 或严重 ST 方面没有显著差异。肝素凝胶治疗患者预防血栓性静脉炎的平均成本效益比为 14.2，QPS 肝素治疗患者为 13.2，QPS 双氯芬酸治疗患者为 95.6。 根据疗效、安全性和成本效益，肝素凝胶或 QPS 肝素可用于预防手术患者因静脉插管导致的 ST。QPS 双氯芬酸不是一种具有成本效益的预防 ST 的选择。
{"title":"Efficacy and safety of quick penetrating solution heparin, quick penetrating solution diclofenac, and heparin gel in the prevention of infusion-associated superficial thrombophlebitis: A randomized controlled trial","authors":"Vijeta Bajpai, Tejas K. Patel, Priyanka Dwivedi, Ankita Kabi, Yashpal Singh, Richa Agarwal, Ravi Gupta, Surekha Kishore","doi":"10.4103/picr.picr_305_23","DOIUrl":"https://doi.org/10.4103/picr.picr_305_23","url":null,"abstract":"\u0000 \u0000 \u0000 The present study aimed to compare the efficacy, safety, and cost-effectiveness of quick penetrating solution (QPS) heparin, QPS diclofenac, and heparin gel in the prevention of superficial thrombophlebitis (ST).\u0000 \u0000 \u0000 \u0000 This randomized controlled trial was conducted after approval from the Institutional Ethics Committee and registration to Clinical Trial Registry of India. Patients of 18–60 years age, American Society of Anesthesiologists I/II, and who needed venous cannulation for at least 72 h were included in the study. Patients were randomly divided into three groups receiving study drugs (heparin gel, QPS heparin, and QPS diclofenac) every 8 hourly for a period of 72 h. Venous cannulation site was graded using the Visual Infusion Phlebitis Scale. Patients developing no ST, mean time to reach ST Grade 1 and 2, prevention of ST probability, and cost-effectiveness of interventions during the study period were assessed.\u0000 \u0000 \u0000 \u0000 Out of 219 included patients, development of no ST in the study groups at 72 h of treatment were heparin gel (11%), QPS heparin (9.6%), and QPS diclofenac (2.7%). The mean time (hours) to develop any grade ST in the study arms was heparin gel (36.2 [11.9]), QPS heparin (40.0 [13.4]), and QPS diclofenac (37.0 [13.2]). The Kaplan–Meier analysis did not reveal significant differences for the prevention of any grade ST or severe ST in three treatment arms. The average cost-effectiveness ratio for preventing thrombophlebitis was 14.2 in heparin gel-, 13.2 in QPS heparin-, and 95.6 in QPS diclofenac-treated patients.\u0000 \u0000 \u0000 \u0000 Based on efficacy, safety, and cost-effectiveness, heparin gel or QPS heparin can be used to prevent ST due to intravenous cannulation in surgical patients. QPS diclofenac is not a cost-effective option to prevent ST.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141661090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-10DOI: 10.4103/picr.picr_265_23
M. Kanimozhi, Manisha Bisht, Ravikant, Arkapal Bandyopadhyay, Manisha Naithani, S. Handu
The objective of the study was to estimate the pleiotropic effect of teneligliptin on high-sensitivity C-reactive protein (hs-CRP) levels and some cardiorenal parameters in comparison to glimepiride, both as add-on therapy to metformin. This 12-week open-label, parallel-group, randomized controlled trial was conducted among Indian people with type 2 diabetes mellitus and on metformin monotherapy with poor glycemic control (glycated hemoglobin >7% or 53 mmol/mol). The endpoints were mean change in hs-CRP levels, systolic blood pressure (SBP), diastolic blood pressure (DBP), serum creatinine, blood urea, estimated glomerular filtration rate (eGFR), and change in cardiovascular (CV) risk categories from baseline to end of 12 weeks. Seventy participants were randomized (1:1) to receive either teneligliptin 20 mg once daily (n = 35) or glimepiride 1 mg twice daily (BD) (n = 35) as an add-on to metformin 500 mg BD. The mean age of the participants was 50.65 and 50.7 years in arms 1 and 2, respectively. At 12-weeks end, teneligliptin add-on caused a statistically significant reduction in hs-CRP compared to glimepiride in both per-protocol (PP) and intention-to-treat (ITT) sets. No significant difference was observed for changes in SBP and DBP, creatinine, urea, eGFR levels, and CV risk category in both PP and ITT sets. Teneligliptin add-on resulted in favorable effects on hs-CRP levels and comparable effects on cardiorenal parameters compared to glimepiride add-on therapy at 12-weeks end. This trial has been prospectively registered in CTRI (Clinical Trials Registry of India). Registration number: CTRI/2021/08/035342.
{"title":"Pleiotropic effect of teneligliptin versus glimepiride add-on therapy on hs-CRP and cardiorenal parameters in Indian type 2 diabetes patients: An open-labeled randomized controlled trial","authors":"M. Kanimozhi, Manisha Bisht, Ravikant, Arkapal Bandyopadhyay, Manisha Naithani, S. Handu","doi":"10.4103/picr.picr_265_23","DOIUrl":"https://doi.org/10.4103/picr.picr_265_23","url":null,"abstract":"\u0000 \u0000 \u0000 The objective of the study was to estimate the pleiotropic effect of teneligliptin on high-sensitivity C-reactive protein (hs-CRP) levels and some cardiorenal parameters in comparison to glimepiride, both as add-on therapy to metformin.\u0000 \u0000 \u0000 \u0000 This 12-week open-label, parallel-group, randomized controlled trial was conducted among Indian people with type 2 diabetes mellitus and on metformin monotherapy with poor glycemic control (glycated hemoglobin >7% or 53 mmol/mol). The endpoints were mean change in hs-CRP levels, systolic blood pressure (SBP), diastolic blood pressure (DBP), serum creatinine, blood urea, estimated glomerular filtration rate (eGFR), and change in cardiovascular (CV) risk categories from baseline to end of 12 weeks.\u0000 \u0000 \u0000 \u0000 Seventy participants were randomized (1:1) to receive either teneligliptin 20 mg once daily (n = 35) or glimepiride 1 mg twice daily (BD) (n = 35) as an add-on to metformin 500 mg BD. The mean age of the participants was 50.65 and 50.7 years in arms 1 and 2, respectively. At 12-weeks end, teneligliptin add-on caused a statistically significant reduction in hs-CRP compared to glimepiride in both per-protocol (PP) and intention-to-treat (ITT) sets. No significant difference was observed for changes in SBP and DBP, creatinine, urea, eGFR levels, and CV risk category in both PP and ITT sets.\u0000 \u0000 \u0000 \u0000 Teneligliptin add-on resulted in favorable effects on hs-CRP levels and comparable effects on cardiorenal parameters compared to glimepiride add-on therapy at 12-weeks end.\u0000 This trial has been prospectively registered in CTRI (Clinical Trials Registry of India). Registration number: CTRI/2021/08/035342.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"44 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141660230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.4103/picr.picr_289_23
Arunkumar Gondhali, Rakesh Patil, Manoj Dagwar, Ravikant Vishwakarma, H. Lubree, G. Dayma, A. Kawade, Aditi Apte
{"title":"Experience of participating in community-based clinical trials from rural Maharashtra: Analysis of over 4000 participant feedback forms","authors":"Arunkumar Gondhali, Rakesh Patil, Manoj Dagwar, Ravikant Vishwakarma, H. Lubree, G. Dayma, A. Kawade, Aditi Apte","doi":"10.4103/picr.picr_289_23","DOIUrl":"https://doi.org/10.4103/picr.picr_289_23","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"1 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141695311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.4103/picr.picr_109_24
Sanish Davis
{"title":"Clinical trial footprint in BRICS: Improvements seen but needs further affirmative action","authors":"Sanish Davis","doi":"10.4103/picr.picr_109_24","DOIUrl":"https://doi.org/10.4103/picr.picr_109_24","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"28 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141704687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.4103/picr.picr_103_24
Arun Bhatt
Indian biotech startup sector – a rapidly growing business segment focused on the development of innovative products has the potential to make significant contributions to the country’s economy. Indian bio-entrepreneurs’ optimistic expectation of rapidly moving product development from bench to bedside faces tremendous challenges of the complex Indian regulatory system, which is shaped by a diversity of regulatory authorities, rules, guidelines, and processes. This brief review discusses specific regulatory issues faced by bio-entrepreneurs investing in a variety of innovative products – new drugs, vaccines, medical devices, cell, and gene therapy and suggests approaches which can ease Indian entrepreneur’s endeavors.
{"title":"Bio-entrepreneurs’ bugbear: Regulatory rigmarole","authors":"Arun Bhatt","doi":"10.4103/picr.picr_103_24","DOIUrl":"https://doi.org/10.4103/picr.picr_103_24","url":null,"abstract":"\u0000 Indian biotech startup sector – a rapidly growing business segment focused on the development of innovative products has the potential to make significant contributions to the country’s economy. Indian bio-entrepreneurs’ optimistic expectation of rapidly moving product development from bench to bedside faces tremendous challenges of the complex Indian regulatory system, which is shaped by a diversity of regulatory authorities, rules, guidelines, and processes. This brief review discusses specific regulatory issues faced by bio-entrepreneurs investing in a variety of innovative products – new drugs, vaccines, medical devices, cell, and gene therapy and suggests approaches which can ease Indian entrepreneur’s endeavors.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"222 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141692473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.4103/picr.picr_100_24
P. Ranganathan, Vishal Deo, C. Pramesh
Calculation of sample size is an essential part of research study design since it affects the reliability and feasibility of the research study. In this article, we look at the principles of sample size calculation for different types of research studies.
{"title":"Sample size calculation in clinical research","authors":"P. Ranganathan, Vishal Deo, C. Pramesh","doi":"10.4103/picr.picr_100_24","DOIUrl":"https://doi.org/10.4103/picr.picr_100_24","url":null,"abstract":"\u0000 Calculation of sample size is an essential part of research study design since it affects the reliability and feasibility of the research study. In this article, we look at the principles of sample size calculation for different types of research studies.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"40 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141698090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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