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   Table of Contents - Current issue
Coverpage
January-March 2020
Volume 11 | Issue 1
Page Nos. 1-50

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EDITORIAL  

Embedding good clinical practice into investigator-initiated studies or trials p. 1
Sanish Davis
DOI:10.4103/picr.PICR_2_20  
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REVIEW ARTICLE Top

Compassionate drug use: Current status in India Highly accessed article p. 3
Yashashri C Shetty, Smita Brahma, PS Manjesh
DOI:10.4103/picr.PICR_119_18  
The World Health Organization defines compassionate use (CU) as a “program that is intended to provide potentially life-saving experimental treatments to patients suffering from a disease for which no satisfactory authorized therapy exists and/or who cannot enter a clinical trial. For many patients, these programs represent their last hope.” Over the years, an increasing number of requests and isolated cases have paved the way for more robust CU programs by pharmaceutical companies and guidelines by eminent regulatory bodies globally. In India, although there is no formal mention of the term “Compassionate Use” by the Central Drugs Standard Control Organization, there are provisions in the Drugs and Cosmetics Act 1940 and Rules 1945 to allow drugs to be imported as and when necessary. Such applications can be submitted to the Drug Controller General of India by a hospital, patient, or a pharmaceutical company. The evidence of such use of drugs is underlined by the availability of bedaquiline and delamanid for extensively drug-resistant tuberculosis (TB) and multidrug-resistant TB patients, respectively. CU is in its nascent stage in India owing to the lack of policies and laws needed to govern it. There is a need for regulatory bodies and pharmaceutical companies to work together to extend the spectrum of CU of drugs for the betterment of needy patients.
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ORIGINAL ARTICLES Top

A review of clinical studies involving pregnant women registered in the Clinical Trials Registry of India p. 8
Sonali Rajiv Karekar, SG Pooja, Padmaja Anil Marathe
DOI:10.4103/picr.PICR_157_18  
Context and Aims: Pregnant women undergo physiological changes which influence the efficacy as well as safety of medications used. Very few drugs are tested and approved for medical conditions during pregnancy, and less pharmacokinetic data are available to form clinical treatment guidelines. There was no data available regarding the type of research studies conducted in pregnancy in India. Hence, we conducted this study to analyze the type of research studies in pregnancy registered in the Clinical Trials Registry of India (CTRI). Subjects and Methods: Following exemption from review by the Institutional Ethics Committee, all studies in pregnant women registered in CTRI from its inception in July 2007 to June 2018 were reviewed. Data were captured with respect to geographical distribution, trimester of pregnancy, study designs used, therapy area, and funding. Statistical Analysis Used: The variables were analyzed using descriptive statistics using SPSS version 16.0. Results: Out of a total of 14,911 studies in CTRI, a total of 285 (1.91%) studies involved pregnant women. Of these studies, 199 (69.8%) were interventional, whereas 86 (30.1%) were observational. Of all the interventional studies, 119 (60%) tested drugs, 47 (24%) tested a nondrug intervention, and the rest were nutraceuticals, Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy, and vaccines. Postgraduate theses constituted 140 (49.1%) studies, 79 (27.7%) were academic projects, 27 (9.4%) were government-funded studies, and only 16 (5.6%) were pharmaceutical-sponsored studies. The most commonly studied therapy area was anesthesia, followed by hypertension and induction of labor. Conclusions: This study depicts underrepresentation of pregnant women in clinical studies and more evidence needs to be generated with respect to drug safety and pharmacokinetics.
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A comparative study to evaluate quality of data documentation between investigator-initiated and pharmaceutical industry-sponsored studies p. 13
Brinal H Figer, Keyur P Sapra, Nithya J Gogtay, Urmila M Thatte
DOI:10.4103/picr.PICR_122_18  
Purpose: In pharmaceutical industry funded clinical studies (PIS), there is rigorous monitoring to ensure adequate and accurate data documentation. In comparison, the investigator-initiated studies (IIS) often lack in resources and may not follow such quality checks. At present, very limited data on the existing deficiencies in documentation for IIS are available. Hence, the present study assessed data quality in IIS relative to those funded by the industry to identify and address issues in data documentation. Materials and Methods: We evaluated records of 1276 participants in 13 studies (5 – industry sponsored and 8 – investigator initiated) conducted during 2009–2015 using a prevalidated checklist. The percentage total scores for overall documentation and general trial-related and patient-specific documents were calculated. The percentage total scores within the patient-specific documents were also calculated and compared. Between-group score analysis was done by Student's t-test using GraphPad InStat version 5.0. Results: The mean (standard deviation [SD]) percentage total score for the IIS was 80.96 (13.26) and that for PIS was 98.77 (1.84) (P = 0.01). For IIS, the total percentage scores ranged from 63% to 100% while it was above 95% for all PIS. For general trial-related documents, the mean (SD) percentage total score for IIS was 90.39 (13.26) while that for PIS was 97.38 (0.92) (P > 0.05). In the patient-specific documents, IIS scored 80.52 [14.41] versus 98.95 (1.98) for PIS (P = 0.016). The scores for IIS versus PIS (70.22 [21.6] and 99.36 [1.43]) within patient-specific documents were significant only for admission criteria (P = 0.016). Conclusion: Quality of IIS needs to be addressed by greater oversight and periodic quality control assessments.
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Factors most influencing antibiotic stewardship program and comparison of prefinal- and final-year undergraduate medical students p. 18
Bikash Ranjan Meher, Anand Srinivasan, CS Vighnesh, Biswa Mohan Padhy, Rashmi Ranjan Mohanty
DOI:10.4103/picr.PICR_162_18  
Background: As future practitioners, undergraduate medical students have a key role in the antimicrobial stewardship program (ASP). However, at present, there are not much data about their knowledge and perception of antibiotic resistance and ASP. Methods: This was a cross-sectional questionnaire-based survey administered to the prefinal- and final-year undergraduate medical students of a tertiary care institution. Results: One hundred and ninety-seven students participated in our study constituting 70% response rate. The mean difference in knowledge score between prefinal- and final-year students was 0.77 (95% confidence interval: 0.30–1.24, P = 0.0016). Thirty-seven (39.7%) prefinal- and 57 (54.8%) final-year students knew the correct definition of antimicrobial stewardship. Majority of the participants, i.e., 66 (70.9%) prefinal-year and 80 (76.9%) final-year students perceived antibiotic resistance as a public health problem. Principal component analysis revealed the greater role of attitude-related questions. Conclusion: Good knowledge and positive attitude are paramount for the effective implementation of the antibiotic stewardship program. Our study revealed that the knowledge gap exists among the undergraduate students about the rational use of the antibiotic stewardship program. It was also revealed that the role of attitude plays a more significant role than knowledge for the proper understanding of the program. A sustained effort is required to make them aware of the rational use of antibiotics by incorporating the knowledge and practice of the ASP into their study curriculum.
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Postlicensure surveillance of human papillomavirus vaccine using the Vaccine Adverse Event Reporting System, 2006–2017 p. 24
Reddy Neha, Viswam Subeesh, Elsa Beulah, Nair Gouri, Eswaran Maheswari
DOI:10.4103/picr.PICR_140_18  
Background: The United States Food and Drug Administration (FDA) has licensed three HPV (Human papilloma virus) vaccines. The centers for disease control and prevention (CDC) and advisory committee on immunization practices (ACIP) recommends routine HPV vaccination at age 11 or 12 years. This study aimed to summarize and characterize adverse events following HPV vaccination reported to VAERS database from July 2006 to May 2017. Methods: A systematic data mining was performed in the VAERS database for reports associated with HPV vaccine. Clinically relevant Vaccine Event Combinations (VEC) were identified in the VAERS database following HPV vaccination. A VEC was considered for analysis only if a minimum of hundred reports were present in database for the given Adverse Event (AE). The data mining algorithm used in this study was reporting odds ratio. A value of ROR-1.96SE >1 was considered as positive signal. Results: VAERS received 49444 reports after receipt of HPV vaccine during the study period. Out of 49444, 2307 unique reactions were identified. A total of 177 death reports and 3526 non death serious reactions were reported to VAERS. ROR showed positive signals for abdominal pain, syncope, dizziness, convulsion, abortion spontaneous, alopecia, amenorrhea, anogenital warts, cervical dysplasia, anaemia, dyskinesia, migrane, blood pressure decreased, fall, head injury, loss of consciousness, pallor, presyncope, seizures. Conclusion: The present analysis did not identify any new/unexpected safety concern and was consistent with the safety data from prelicensure trials. Further epidemiological studies are required to systematically validate the data provided by VAERS.
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Off-label drugs use in neurology outpatient department: A prospective study at a tertiary care teaching hospital p. 31
Kunj Arun Gor, Kartik N Shah, Pranav B Joshi, Harsh M Joshi, Devang A Rana, Supriya D Malhotra
DOI:10.4103/picr.PICR_117_18  
Background: Off-label drug use refers to any use of an approved or cleared drug that is not included in that product's approved labeling or cleared indications for use. It may be in terms of indication, age group, dosage, or route of administration. Off-label drug prescriptions are common neurology practice. Aim: The aim of the study is to evaluate the prevalence pattern of off-label drug use in neurology. Subjects and Methods: A prospective, observational, cross-sectional study was carried out in the neurology outpatient department of tertiary care teaching hospital. Data of patients above 18 years were recorded after obtaining their informed consent. The National Formulary of India (NFI) and British National Formulary (BNF) guidelines were used as tools for evaluation of the prevalence of off-label drug use. Results: A total of 709 drugs were recorded from the prescription data of 205 patients collected in the duration of 2 months. The results reported 145 (20.45%) and 317 (44.71%) drugs as off-label as per the NFI and BNF, respectively. Prescriptions with minimum 1 off-label drug use were 78.05% – BNF and 46.83% – NFI. The indication was one of the most common causes of drugs being off-label. Out of the total 317 off-label drug uses reported, 84 were unlicensed drug use as per the BNF. There is strong and positive correlation established between the age of the patients, number of drugs prescribed, and total off-label drugs prescribed per patient in the given study. The most common off-label drug use noted was with clonazepam and amitriptyline. Conclusion: Off-label prescriptions practice is common in the field of neurology.
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ETHICS EDUCATION Top

New drugs and clinical trials rules 2019: Changes in responsibilities of the ethics committee p. 37
Neelu Singh, Nivedita J Madkaikar, Partha M Gokhale, Deven V Parmar
DOI:10.4103/picr.PICR_208_19  
The New drugs and Clinical trials rules 2019 (New rules) was introduced on 19th March 2019 by Government of India. New rules have set specific requirements for ethics committee (EC). The EC is required to follow requirements set as per New rules and to forward their report to Central Licensing Authority (CLA). This document is divided into different sections like definitions and applicable chapter & schedules for EC; changes related to registration of clinical studies and biomedical and health research; changes related to constitution, functions, proceedings, responsibility of EC for clinical trial; maintenance of records by EC; suspension and cancellation of registration of EC, post-trial access of drugs, changes and clarity related to academic clinical trials and role of ECs in compensation and medical management process.
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READING BETWEEN THE LINES Top

CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with T2D trial p. 44
Baishali Nath, Viraj Ramesh Suvarna
DOI:10.4103/picr.PICR_157_19  
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STATISTICS Top

Study designs: Part 5 – Interventional studies (III) p. 47
Priya Ranganathan, Rakesh Aggarwal
DOI:10.4103/picr.PICR_209_19  
Several methodological and statistical aspects of clinical trials can affect the robustness of their results. We conclude the series of articles on “Interventional Studies” by discussing some of these features.
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