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   Table of Contents - Current issue
April-June 2021
Volume 12 | Issue 2
Page Nos. 63-114

Online since Friday, March 12, 2021

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Medication package inserts: Complete, accurate, and up-to-date p. 63
Veena Jaguste
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The changing perspective of clinical trial designs p. 66
Yamini Ajmera, Sunny Singhal, SN Dwivedi, AB Dey
Maintaining health and well-being of the population is a universal priority. Governments around the globe are therefore seeking greater efficiency and better outcomes from researches being held. Although large randomized trials or systematic review of several large trials provides the highest level of evidence, the intricate cost, time, and difficulties of conventional trials have led to questions about their sustainability commanding search for alternative approaches. Demands for improved competences in medical research have led to mounting interest in newer clinical trial designs. This article provides an insight into newer clinical trial designs, including cluster trials, adaptive designs, the master protocols along with their strengths, weaknesses, and which trials design should be opted for in different clinical scenarios.
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Has mandatory prospective registration of all studies brought about a change? A 1-year audit of studies registered in the Clinical Trials Registry of India [CTRI] before and after April 1, 2018 p. 72
Nayana S Shetty, Rachana A Salvi, Urmila M Thatte, Nithya J Gogtay
Introduction: The Clinical Trials Registry of India (CTRI) that initially permitted retrospective registration moved to mandatory prospective registration of studies with effect from April 1, 2018. The present study was an audit that compared registration 1 year post the rule versus a year prior to it. Materials and Methods: All studies registered with the CTRI from April 1, 2017, to March 31, 2018, and subsequently from April 1, 2018, to March 31, 2019, were included for the analysis. The extents of retrospective registration a year pre and a year post April 1, 2018, of all studies were evaluated. Results: A total of 4628 studies were registered prior to April 1, 2018, and 5438 post that. Pre April 1, 2018, 2687 / 4628 (58.06%) studies were retrospectively registered, while post that, 1100 / 5438 (20.23%) studies were retrospectively registered (cOR: 5.46 [5.0, 5.9], P < 0.001). Regardless of whether the studies were PG theses, regulatory studies, observational studies, or interventional studies, there was a statistically significant reduction in the number retrospectively registered post April 1, 2018, relative to the year predating it. Discussion and Conclusion: The success of CTRI's decision to move to prospective registration is seen in the overall reduction in the total number of retrospective registrations from nearly two-thirds in the year predating April 1, 2018, to just a quarter in the year post that, indicating significant inroads made by the CTRI with regard to raising awareness. Some regulatory studies continue to be retrospectively registered and this presents a significant ethical and regulatory breach. This could be potentially addressed by linking ethics committee approval with trial registration.
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Impact of newer direct-acting antiviral drugs based on quality-adjusted life years: A prospective pharmacoeconomic study in hepatitis C patients p. 76
Bhavya H Vyas, Nishita H Darji, Devang A Rana, Kaushal Y Vyas, Supriya D Malhotra
Context: The Indian government is dispensing newer direct-acting antiviral (DAA) drugs, which may have impact on hepatitis C virus (HCV) patients’ quality of life (QoL). Aims: To evaluate different DAA regimens and impact on QoL in terms of quality-adjusted life year (QALY) in HCV patients and to measure cost-effectiveness. Methods: This prospective, observational study was carried out on patients who were diagnosed with HCV. Recruited patients were followed up until 12–24 weeks. Patients were recruited following the selection criteria. Along with demographic and drug details, the regimens used were analyzed and evaluated for cost minimization, cost-effectiveness, and cost–utility analysis. For health quality check, the Chronic Liver Disease questionnaire (CLDQ) was used which was also used for QALY assessment. Data were entered into MS Excel 2016. Difference in between the regimens for total cost was done using unpaired t-test and ANOVA test using SPSS 25.0. Overall cost-effectiveness, cost minimization, cost utility and cost of illness analysis was also calculated.P < 0.05 was considered statistically significant. Results: A total of 31 patients were enrolled. A total of five drugs, namely, sofosbuvir, daclatasvir, ribavirin, velpatasvir, and ledipasvir were widely used. Sofosbuvir was most common (46.25%)component of drug combination in our study. A total of five types of regimen were used according to the genotype of patients. With 44,260.13 ± 15,884.92 INR of the total drug cost, 70.97% of patients spent around 30,000–40,000 INR for the whole pharmacotherapy. The total indirect cost was 2768.39 ± 3916.13 INR with the total direct cost of 48,660.90 ± 15,356.39 INR. The total cost including direct as well as indirect cost spent during 6-month therapy by 61.29% of patients was 40,000–50,000 INR. Based on the CLDQ score, QoL was 64.1 ± 25. Regimen 2 (sofosbuvir + velpatasavir) stood out with the lowest cost. Regimen 5 (ribavirin [200 mg] + sofosbuvir [400 mg] + velpatasvir [100 mg]) was found to be the most cost-effective. Considering 1 life year with good health after treatment, QALY was 0.31. Conclusions: Ribavirin (200 mg) + sofosbuvir (400 mg) + velpatasvir (100 mg) was found to be the cost-effective and cost-saving regimen among DAAs.
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Development and validation of patient information leaflet for coronary heart disease patients p. 83
BC Vinay, CS Shastry, Subramanyam Kodangala, Uday Venkat Mateti, Krishna Bhat
Background: Patient information leaflets (PILs) are effectively used to improve the patient's knowledge about medications, disease, diet, and lifestyle modifications. Aim: This study aims to develop and evaluate PILs for coronary heart disease patients. Materials and Methods: Primary, secondary, and tertiary resources were used to develop PILs. The developed PILs were validated by four doctors, four academic pharmacists, and one dietician. PILs design and layout was prepared using barker able leaflet design (BALD) criteria. PILs readability was assessed using the Flesch Reading Ease test (FRE), Flesch–Kincaid Grade Level (FKGL), and user readability methods. User opinion on PILs content and design was obtained from patients. Results: The FRE and FKGL readability scores were 61.5 and 7.4, respectively. The BALD criteria scores for English, Kannada, and Malayalam PILs were 28, 27, and 26, respectively. The overall user testing readability means scores had significantly improved from 45 to 79.30. Nearly 82.55% of patients rated the PILs as good design and content. Conclusion: The developed leaflet met the standard criteria for easy reading and comprehension. The majority of the patients gave good opinion on the content and design of the PILs.
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Information adequacy of medicine package inserts in India: A critical evaluation p. 87
Bikramjit Barkondaj, Kaushik Mukhopadhyay, Suvajit Das, Chandan Chatterjee, Sonali Mukherjee, Avijit Hazra
Objectives: Package inserts (PIs) are used by physicians and other health-care providers as ready source of approved prescribing information. In India, they are subject to statutory regulations that specify the information to be provided under various headings. Uniformity of PIs with optimal level of information is desirable, the absence of which may lead to medication errors. This observational study aimed to evaluate the information adequacy and accuracy of PIs available in the Indian market. Materials and Methods: PIs of drugs marketed in India, and approved by United States Food and Drug Administration, were collected from various retail pharmacies through purposive sampling. The adequacy and accuracy of the information in each PI were evaluated with the help of a 25-item checklist prepared as per stipulations mentioned in statutory guidelines. Each required item of information was scored 1 if present and appropriate or 0 if absent or deemed incomplete or inaccurate. A total information adequacy score (IAS), with maximum value 25, was thereby calculated. Results: From the total 135 PIs analyzed, the median IAS was 17 (interquartile range 15–19). Deficiencies were observed under important headings. For example, “references” were mentioned in only 6.67% and “date of last updating” in only 19.26% of PIs. Other notable shortcomings were in “disposal” (not mentioned in 92.59%), “effects on ability to drive and use machines” (76.30%), “pharmaceutical incompatibilities” (66.67%), “shelf life” (62.96%), “excipients” (60.00%), and “overdose” (17.78%) information. Information on “generic name,” “composition,” and “indications” were however provided by all (100%) PIs. Conclusions: The information provided by PIs in India being inadequate, may not be able to serve as a reliable source of information.
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A survey of knowledge and variables influencing perceptions about clinical research: A cross-sectional study from Mumbai p. 93
Brinal H Figer, Swastika S Lamture, Tanmay Gandhi, Ashnik Chauhan, Anchal Gvalani, Nithya Jaideep Gogtay, Urmila Mukund Thatte
Purpose: Clinical research in India has been besieged by controversies. While studies have addressed other stakeholders, few have addressed the patient. The present study was conducted to assess the extent of awareness and understanding about the nature and conduct of CR among people of Mumbai. Methods: Institutional Ethics Committee approval was taken (EC/OA-12/15) and written informed consent was obtained. Adults who were residents of Mumbai were enrolled. A prevalidated and published 48-item questionnaire based on six themes, namely awareness and participation, voluntariness and autonomy, compensation, confidentiality, safety, and involvement in CR were administered. Perception based on themes and association of variables such as age, gender, socioeconomic class, and education on this perception was assessed. Descriptive statistics along with Chi-square test/Chi-square test for trend and crude odds ratio (cOR) were assessed. Results: Of the 453 participants approached, 400 (age 32 [18–96]) consented. Only 210/400 (52.5%) were aware of CR and 194/400 (48.5%) said they needed permission for participation. Only 226/400 (56.5%) were aware of their rights and 111/400 (27.75%) felt that clinical trial participants received compensation. The socioeconomic class influenced awareness of CR (P < 0.00001; r2 = 0.495) as did the age (P < 0.0001; r2 = 0.82). Men were less likely to need permission to participate relative to women (cOR [95% confidence interval (CI)] 2.47 [1.6, 3.6] [P < 0.00001]). Those who had heard of CR were twice more willing to participate (cOR [95% CI] 1.72 (1.2, 2.6); P = 0.008). Conclusions: There is a greater need to improve awareness, especially about safety, compensation, and confidentiality in CR.
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Critical appraisal of published research papers – A reinforcing tool for research methodology: Questionnaire-based study p. 100
Snehalata Gajbhiye, Raakhi Tripathi, Urwashi Parmar, Nishtha Khatri, Anirudha Potey
Background and Objectives: Critical appraisal of published research papers is routinely conducted as a journal club (JC) activity in pharmacology departments of various medical colleges across Maharashtra, and it forms an important part of their postgraduate curriculum. The objective of this study was to evaluate the perception of pharmacology postgraduate students and teachers toward use of critical appraisal as a reinforcing tool for research methodology. Evaluation of performance of the in-house pharmacology postgraduate students in the critical appraisal activity constituted secondary objective of the study. Materials and Methods: The study was conducted in two parts. In Part I, a cross-sectional questionnaire-based evaluation on perception toward critical appraisal activity was carried out among pharmacology postgraduate students and teachers. In Part II of the study, JC score sheets of 2nd- and 3rd-year pharmacology students over the past 4 years were evaluated. Results: One hundred and twenty-seven postgraduate students and 32 teachers participated in Part I of the study. About 118 (92.9%) students and 28 (87.5%) faculties considered the critical appraisal activity to be beneficial for the students. JC score sheet assessments suggested that there was a statistically significant improvement in overall scores obtained by postgraduate students (n = 25) in their last JC as compared to the first JC. Conclusion: Journal article criticism is a crucial tool to develop a research attitude among postgraduate students. Participation in the JC activity led to the improvement in the skill of critical appraisal of published research articles, but this improvement was not educationally relevant.
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Understanding estimands p. 106
Nithya Jaideep Gogtay, Priya Ranganathan, Rakesh Aggarwal
Randomized controlled trials are the gold standard for determining the efficacy of a new intervention. Trials conducted for regulatory approval of an intervention compare the effect of the intervention with the standard of care or placebo to demonstrate efficacy. Randomization attempts to ensure that all known and unknown confounding factors are evenly distributed between the groups, and that the groups will be comparable at the end of the study, so that any inter-group differences in outcomes can be attributed to the intervention. However, in reality, intercurrent events may impact the assessment and subsequent interpretation of the outcome of interest. To address this, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2017, released an addendum to the E9 guideline (ICH E9 R1) putting forth the concept of Estimands and Sensitivity Analysis in Clinical Trials. This addendum addresses how these intercurrent events are to be handled using the Estimand concept, which is now expected to be detailed in a separate section of the study protocol. In this paper, we discuss what estimands are, and their likely impact on how regulatory trial protocols and their statistical analyses plans are written and implemented. We also look at the application of the concept of estimands to routine clinical practice.
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Only umbilical cord blood banking for stem cells permissible by the Indian Council of Medical Research: Perception of medical professionals p. 113
Anissa Ann Biju, Akila Prashant, Prashant Vishwanath, Shobha Chikkavaddaragudi Ramachandra
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