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   Table of Contents - Current issue
Coverpage
July-September 2021
Volume 12 | Issue 3
Page Nos. 115-176

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EDITORIAL  

Addressing challenges faced by trial sites and investigators p. 115
Sandeep B Bavdekar
DOI:10.4103/picr.picr_118_21  
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REVIEW ARTICLES Top

National guidelines for gene therapy product (2019): A road-map to gene therapy products development and clinical trials p. 118
Kiruthika Sivagourounadin, Mirunalini Ravichandran, Priyadharsini Rajendran
DOI:10.4103/picr.PICR_189_20  
The “National Guidelines for Gene Therapy Product (GTP) Development and Clinical Trials” prepared by the Indian Council of Medical Research and Department of Biotechnology in 2019 came as a welcome step in the process of regulation of gene therapy research, as there was a lack of Indian guidelines earlier specific to gene therapy. Indian researchers have taken their step in setting the path of gene therapy research, and this guideline serves to provide the standards starting from its development up to translation to new drug including the ethical, scientific, and regulatory requirements to be followed during the conduct of trial. The Indian guidelines were framed with reference to United States-Food and Drug Administration and European Union guidelines on gene therapy. It is the responsibility of all the stakeholders involved in the development of GTP to adhere to the national guidelines. This review provides an outline of the Indian regulatory guidelines on GTP.
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Conducting community-based pediatric research in rural India: Experience from vadu rural health program p. 126
Aditi Apte, Girish Dayma, Himangi Lubree, Anand Kawade, Sanjay Juvekar, Ashish Bavdekar
DOI:10.4103/picr.picr_325_20  
This paper describes unique challenges faced during conduct of community research studies in rural population of Maharashtra at Vadu Rural Health Program, Pune, India. Some of the ethical issues faced include difficulty in comprehending the informed consent by rural families with low education levels and ensuring adequate compensation for study participation without undue inducement, ensuring large number of recruitments during early infancy, ensuring adherence to intervention by care-providers, retention of participants especially in studies having long follow-ups and regulatory compliance for serious adverse event reports are major operational challenges. The delays faced in approvals from the Health Ministry Screening Committee and lack of specific regulatory guidance on community-based conduct of studies pose challenges in terms of study timelines and operational aspect of these studies. Provision of study-related information during prestudy visits, designing patient information sheets in simple language, involving the decision-making member of the family, adequate time for families for decision-making are certain measures that have been useful for effective informed consent administration. Collaboration with accredited social health activists and auxillary nurse midwives for line-listing of pregnancies and births and regular conduction of prestudy visits or community sensitization meetings have been useful for the recruitment of large number of study participants during infancy. Strategies such as provision of universal immunization, selection of field research assistants from the local population, regular home visits, and provision of medical care has been helpful in retention of the study participants. Networking with local health facilities and local government bodies has helped in the provision of medical care to the study participants and in the management of serious adverse events. Our experience can provide important learnings to other investigators from developing countries working in the domain of child health.
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ORIGINAL ARTICLES Top

Compliance of Mumbai-based clinical trial sites with the Quality Council of India guidelines and evaluation of the challenges faced by the investigators p. 133
Brinal Figer, Nithya Jaideep Gogtay, Urmila Mukund Thatte
DOI:10.4103/picr.PICR_22_20  
Purpose: A committee chaired by Dr. Ranjit Roy Chaudhary suggested accreditation of investigators, sites and ethics committees to improve the quality of trial conduct in the country. Prior to accreditation, understanding the challenges faced at the sites by investigators could help define the extent of the problem and identify potential solutions. Hence, we conducted the present study. Methods: Institutional Ethics Committee approval and written informed consent was obtained prior to enrolment. A checklist and a questionnaire was used to assess compliance to Quality Council of India (QCI) standards and the challenges faced by the sites and investigators respectively. Mumbai based investigators listed in the Clinical Trial Registry of India (CTRI) were enrolled. The responses obtained were analysed descriptively. The responses to each question in the checklist were calculated as a proportion and response to each item in the questionnaire was calculated in frequency and percent frequency. All the analysis was done using Microsoft Excel version 2013. Results: A total of 30 investigators from 69 clinical trial sites agreed to participate. We found that over 80% of the sites complied with standards recommended by the QCI guideline. The most frequently reported issues at the site were lack of space for archival (25%), no System to evaluate adequacy of training (31.81%) and lack of understanding of the technical language of the informed consent form (39.02%). Conclusion: There is a need of coordinated effort between all the stakeholders to improve the clinical trial conduct at the site.
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A study of perceptions and exposure of drug promotional literature among clinicians in a teaching hospital p. 140
Sushil Sharma, Neha Akhoon, Htet Wai Moe, Deepak R Nair, Venkat Shashidhar
DOI:10.4103/picr.PICR_36_19  
Background: Drug promotional literature (DPL) forms a major marketing technique of pharmaceutical companies for propagating information regarding a drug. Many a times, it is the only source on which treating physicians depend for updating their knowledge about the existing and novel drugs. Aims and Objectives: This study was conducted to understand the clinicians’ perceptions about DPL and its critical appraisal so that relevant interventions can be made. Materials and Methods: It was a cross-sectional questionnaire based study. A self-administered validated questionnaire was administered to 125 clinicians working in a medical college, which sought responses on their perception of various aspects including interpretation, analysis, evaluation, inference and decision making based on the DPL which they encounter in their day-to-day practices. The data was analyzed using descriptive statistics. Results: A total of 100 clinicians reciprocated with complete questionnaire. 99% of the clinicians were exposed to pharmaceutical promotional activities and around 79% clinicians accepted that drug promotion has a considerable bearing on their prescribing practices. Majority (79%) of the clinicians felt that the accuracy of the claims in the various forms of DPL was between 50-75%. Amongst the various forms of DPL, brochures were adjudged as the most useful followed by interactions with medical representatives, advertisements in medical journals and direct mailers. a majority of the clinicians (69%) felt that, though the claims in the DPL are balanced but are supported by poor evidence. Around 75% clinicians perceived the primary intention of drug promotional literature was to boost company sales. Around 84% clinicians felt that doctors’ integrity can be compromised by accepting gifts from medical representatives. Over 75% of clinicians believed that training in interacting with medical representatives and assessing other forms of drug promotional literature should be imparted to undergraduates in medical colleges. Conclusion: Physicians need to be aware that the pharmaceutical industry may use drug advertisements to influence prescription patterns even when this results in distortion of scientific facts. The pharmaceutical industry should be more responsible and more meticulous in making sure that pharmaceutical claims referring to scientific studies are quoted accurately.
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Knowledge, attitude, and practices of health-care providers toward antibiotic prescribing, antibiotic resistance, and multidrug-resistant tuberculosis p. 146
Ashna Malhotra, Vimal Kumar, Deepak Juyal, Deepak Gautam, Rajesh Malhotra
DOI:10.4103/picr.PICR_122_19  
Introduction: Antibiotic resistance (ABR) is a growing public health problem and is a subject of international concern. It poses a serious threat to health and health-care systems in both developed and developing countries. The problem is more confounding with tuberculosis (TB), and drug resistance in TB has threatened the progress made in TB care and control worldwide. The aim of this study was to understand the knowledge, attitude, and practices of health-care providers (HCPs) toward antibiotics, antibiotic prescribing, ABR, and multidrug-resistant TB (MDR-TB). Materials and Methods: A total of 125 participants were included in this cross-sectional, questionnaire-based survey conducted in tertiary care teaching hospitals of the Delhi-NCR region. A five-point Likert scale, whose responses ranged from “strongly agree” to “do not know,” was used to record the responses from participants. Results: Among the 125 HCPs who participated in the survey, the response rate was 100%. Around 94.4% of the respondents agreed that ABR is an important and a serious public health issue. More than 80% of the respondents strongly agreed that over-the-counter sale and/or dispensing antibiotics without prescription should be controlled. About 86.4% of the participants agreed that MDR-TB is a growing problem and 59.2% strongly agreed that indiscriminate use of anti-TB drugs could be a major causative factor. Almost 85.6% of the participants agreed that a proper diagnosis should be ensured before treating the TB cases. Conclusions: HCPs had a good knowledge of antibiotics and the association of its misuse or overuse with increasing ABR. Educational and persuasive measures are certainly needed, but the use of restrictive and organizational measures appears mandatory if the misuse of antibiotics is to be decreased in the near future. A stringent assessment of the impact of implemented measures seems essential to better guide antibiotic stewardship in our country.
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Assessment of adherence to medication during chronic illnesses in pregnancy p. 153
Smita Sontakke, Vrushali Takalikar, Jitendra Deshmukh, Vijay M Motghare, Mrunalini Kalikar, Avinash Turankar
DOI:10.4103/picr.PICR_111_19  
Purpose/Aim: To evaluate adherence to medication in chronic illnesses during pregnancy and to identify factors responsible for non-adherence. Methods: This was a prospective, cross-sectional, questionnaire based study initiated after approval of the institutional ethics committee. Pregnant women suffering from any chronic illness (except HIV) were questioned to evaluate adherence to medication in chronic illnesses during pregnancy and to detect factors responsible for non-adherence using a semi-structured, open-ended questionnaire. Adherence to medication was also assessed using 4-item Morisky's medication adherence scale. Results: Rate of high adherence was significantly more (58.77%) with medications for chronic illness compared to medications for normal pregnancy (15.78%). Majority of women were more concerned about the chronic illness and believed that keeping the chronic illness under control is more important for normal growth of the baby. Unawareness about usefulness of each medicine and forgetfulness were the most common reasons for non-adherence to medications. Not taking prescribed dose was the most common type of non-adherence. Level of adherence positively correlated with level of education while it was inversely related to number of tablets per day. Conclusion: Higher adherence to medications for chronic illnesses during pregnancy is an encouraging finding but at the same time poor adherence to medications for normal pregnancy is a matter of concern. Most of the issues responsible for non-adherence to medication as reported in this study can be resolved to a significant extent by planning and implementing interventions aimed at improving adherence to treatment during pregnancy in which health professionals play a major role.
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An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004–2018) p. 159
Mahanjit Konwar, Mitesh R Maurya, Tushar B Nishandar, Urmila M Thatte, Nithya J Gogtay
DOI:10.4103/picr.PICR_99_19  
Background: The approval process of every drug regulatory agency differs, and hence, the time required for the approval of a new drug varies. This results in a drug lag and India is no exception to this phenomenon. A drug lag precludes Indian patients from accessing new medicines at the same time as they are approved elsewhere. Against this backdrop, we assessed the absolute and relative drug lags of the Indian regulator relative to three regulators in mature markets, namely United States (US), European Union (EU), and Japan. Methods: International nonproprietary names were used to identify new drugs. Their dates of approval (2004-2018) from the online database of four regulatory agencies were identified. Both absolute and relative drug lags were calculated for India as compared to US, EU, and Japan as well for all the agencies relative to the Indian regulator. Results: We identified a total of 453, 473, 424, and 472 new drugs approved over the study period in India, US, EU, and Japan, respectively. The absolute drug lag of Central Drugs Standard Control Organization (CDSCO) was 19 and 18 relative to the US Food and Drug Administration (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA), respectively. The relative drug lag for the CDSCO vis-a-vis the US FDA, European Medicines Agency, and PMDA was 43.2 (2.1–1287.8), 25.6 (0.03–1310.5), and 30.3 (1.2–1242) months, respectively. Conclusion: Our study shows a significant drug lag between India and other three developed nations (US, EU, and Japan). However, in some therapeutic areas, Indian regulator has proactively approved new drugs much before other agencies. The New Drugs and Clinical Trials Rule of 2019 has brought hope for reduction in drug lag in the near future.
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An observational study to evaluate the prescription pattern of analgesics used in the perioperative period in a tertiary care hospital Highly accessed article p. 165
Shirish Joshi, Yashashri Shetty, Roshni Panchal, Panini Patankar, Sweta Salgaonkar, Rishabh Rawat, Anuya Natu
DOI:10.4103/picr.PICR_87_19  
Background and Aims: Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. There are limited observational prescription pattern studies of analgesics in perioperative period in tertiary care hospitals for which this study was carried out in orthopedic, general surgery, and plastic surgery departments. The primary aim was to study the prescription pattern of analgesics in the perioperative period with the secondary aim to study the specific use of opioids and pain relief using the Visual Analog Scale (VAS). Methods: A total of 250, 250, and 100 patients were taken from orthopedic, general surgery, and plastic surgery departments, respectively. The analgesics commonly used in preoperative, intraoperative, and postoperative period were observed. The use of opioids in the perioperative period, the number of fixed drug combinations used, the number of generic drug prescription, and pain relief postoperatively were also observed. The analysis was done using descriptive statistics. Results: Total analgesics prescribed were 1168, 117, and 369 in orthopedic, general surgery, and plastic surgery departments, respectively, and were maximum in the intraoperative period. Most commonly used analgesic in the preoperative and postoperative period was paracetamol and that in intraoperative period was fentanyl. Nonsteroidal anti-inflammatory drugs (NSAIDs) were mainly prescribed by the general surgery department in postoperative period. The amount of pain in postoperative period after treatment with analgesics was mild to moderate as per the VAS. Conclusion: This study revealed that in preoperative and postoperative period, the most common analgesic used is paracetamol. In the intraoperative period, maximum patients received fentanyl. Diclofenac is an established NSAID used in the management of acute and chronic pain states. In our study, we found that the usage of paracetamol was more than NSAIDs and the usage of opioid was maximum during intraoperative period.
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REAL WORLD RESOURCE Top

Introduction to real-world evidence studies p. 171
Deepa Chodankar
DOI:10.4103/picr.picr_62_21  
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BRIEF COMMUNICATION Top

A survey to assess the impact of the COVID-19 pandemic and the resultant lockdown measures on the ongoing clinical trials in India p. 175
Jayanti Gupta, Rakesh N Dadhania
DOI:10.4103/picr.picr_380_20  
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