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   2020| April-June  | Volume 11 | Issue 2  
    Online since May 6, 2020

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Clinical trials during the COVID-19 pandemic: Challenges of putting scientific and ethical principles into practice
Arun Bhatt
April-June 2020, 11(2):59-63
Global pandemic of COVID-19 is a serious unmet medical need requiring clinical research into effective therapies. Clinical trials during pandemics of infections face complex challenges of putting scientific and ethical principles into practice. Some of these issues – selection of investigational product and participants, study design, assessment of efficacy and safety, ethics review, informed consent and publication, sample size, and publications – require in-depth consideration in planning and implementation of clinical trials during pandemics.
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Exploring digital therapeutics: The next paradigm of modern health-care industry
Raj Khirasaria, Vikramjit Singh, Angelika Batta
April-June 2020, 11(2):54-58
In this era of 21st century, the most valuable resource is data. Digital technology can generate terabytes of data which has a tremendous potential in the modern-day world. Pharmaceuticals play an essential role in improving and maintaining the health of patients. However, their cost in health-care budget is a major issue. Due to high prevalence and unfavorable consequences, managing chronic and lifestyle disorders has now become areas of major clinical concern globally. Harnessing this digital technology in our overburdened health-care industry can improve the treatment outcome and even replace the existing treatment. Health authorities such as U.S. Food and Drug Administration (USFDA) are also acknowledging their potential. FDA's Center for Devices and Radiological Health has established the “Digital Health Program” which seeks to promote public health and provide continued regulatory clarity by enhancing outreach to digital health customers and developing and implementing regulatory strategies and policies for digital health technologies. The main focus of this article is to give an overview of digital therapeutics (DT), its clinical applications, role of regulators, and challenges ahead along with potential areas for developers and to present an update on major developments and initiatives taken in this field. The most important advantages of DT are that it has direct access to patients, decreases cost of treatment, encourages healthy lifestyle modifications, and can substitute or complement conventional treatments. Many of these models are still in infancy stage, and further research and development is needed to demonstrate their enormous potential in near future. If used judiciously, they can modernize our health-care industry.
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Recruitment and retention of the participants in clinical trials: Challenges and solutions
Nayan Chaudhari, Renju Ravi, Nithya J Gogtay, Urmila M Thatte
April-June 2020, 11(2):64-69
Drug development is a tedious and expensive procedure and it takes roughly 10 to 15 years to take a potential treatment from bench to bedside and costs the pharmaceutical companies as much as USD ~2 billion for the process. Delay in investigator-initiated studies can cause financial loss to grant providers (either public or private) and investigator's reputation may also be at stake. Participant recruitment and retention are two major bottlenecks in conducting clinical trials and contribute vastly to the delays. They are essential for both scientific validity of the clinical study and economic reasons. Thus, issues in recruitment and retention should be addressed and minimized. A proper recruitment and retention plan incorporating adequate communication between all stakeholders will eventually avoid the delays in drug development and make treatments available to the consumer at an earlier date and at a more affordable price. Awareness of challenges and reviewing strategies that can optimise recruitment and retention will facilitate drug development. The article gives a first-person perspective on challenges and proposed solutions from an experienced clinical study centre in a tertiary care hospital.
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Evaluation of prescribing practices and drug-related problems in chronic kidney disease patients: A cross-sectional study
Viswam K Subeesh, Rishma Abraham, Minnikanti Venkata Satya Sai, Kranthi Swaroop Koonisetty
April-June 2020, 11(2):70-74
Aim: The primary intent of the study is to analyze the prescribing pattern and to identify the various drug-related problems (DRPs) associated with the therapy in chronic kidney disease (CKD) patients. Subjects and Methods: A prospective observational study was conducted in 160 patients diagnosed with any stages of CKD. The prescribing pattern was studied and DRPs were identified, reported, and categorized as per the Pharmaceutical Care Network Europe classification V 5.01. The association between categorical variables was analyzed using the Chi-square test. The predictors of DRPs were identified using binary logistic regression analysis. Results: The mean age of the study population was 50.08 ± 15.32 years with male predominance (71%). The average number of drugs per prescription was found to be 9.16 ± 3.01. The most prescribed drug category was antihypertensives and the most commonly prescribed drugs were diuretics. A total of 337 DRPs were identified, out of which the most common DRP was drug interactions (60%), followed by frequency errors (11.6%). Logistic regression analysis identified comorbidities more than three (odds ratio 2.09), antihypertensives more than two (odds ratio 1.9), alcoholism (odds ratio 1.5), and polypharmacy (odds ratio 1.2) as the predictors of DRPs even though they were not statistically significant at P = 0.01. Conclusion: DRPs increase the risk of deterioration of the disease state and increase the length of hospital stay. Identification and resolving of the DRPs will lead to better patient care and proper treatment. Early identification and modification of the above-mentioned predictors could possibly prevent/reduce DRPs.
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The determinants of out-of-pocket health-care expenses for diabetes mellitus patients in India: An examination of a tertiary care government hospital in Delhi
Saurav Basu, Suneela Garg, Nandini Sharma, M Meghachandra Singh, Sandeep Garg, Miqdad Asaria
April-June 2020, 11(2):86-91
Objective: To assess the determinants of out-of-pocket (OOP) expenses on diabetes-related treatment incurred in patients attending outpatient clinics in a tertiary care hospital in Delhi, India. Study Design: A cross-sectional analysis of baseline data from a quasi-experimental study was conducted over 8 months in 2016 in a major tertiary care hospital in Delhi. Methods: The study included 375 diabetes patients up to 65 years of age on treatment for at least a year without significant complications. Data were collected through a patient interview schedule. Results: Of the previous six scheduled appointments, at least two missed appointments were seen in 267 (71.2%) patients. The average patient's OOP expenditure on diabetes-related medicines was ₹63.5 a month, a similar amount was spent on traveling to and from health facilities. Sixty-four (17.1%) patients took antidiabetic medication for <85% of the days in the previous 3 months. Conclusion: There exists a high burden of missed clinic appointments among diabetes patients in tertiary care government health settings in India. This appears to be related to the high cost in terms of both time and money involved in attending appointments for the modest benefit of a dispensation of a 15-day drug refill. Health policy measures focused on strengthening medication coverage need to explore the balance of costs and benefits when determining the frequency of clinical appointments in these settings.
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An observational study on acute poisoning in a tertiary care hospital in West Bengal, India
Suparna Chatterjee, Vivek Kumar Verma, Avijit Hazra, Jyotirmoy Pal
April-June 2020, 11(2):75-80
Aim: Poisoning is a preventable cause of morbidity and mortality in India. We undertook a prospective observational study to estimate the incidence, nature, severity and treatment outcome trends of acute poisoning in a tertiary care hospital in eastern India. Methods: All patients, admitted during the study period with acute poisoning, drug overdose and envenomation, were enrolled. Food poisonings, animal bites, chronic drug or chemical poisonings were excluded. Medical records were scrutinized and caregiver interviews served as source documents. Demographics, nature and circumstances of the poisoning event, treatment offered, duration of hospitalization and outcome data were collected. Results: Over 18 months, 592 cases of acute poisoning, accounting for 0.63% of all hospital admissions, were enrolled. Males comprised 57.09%, median age was 22 years, and 52.20% hailed from rural area. Occupation-wise, excluding students and children, patients were mostly daily wage workers followed by housewives, service holders and farm workers. Snake bites comprised the largest category of cases at 264 (44.6%) followed by corrosives (13.68%), sedatives/hypnotics (13.18%), pesticides (12.16%), hydrocarbon oils (8.61%) and others. Majority (60.64%) of the cases was accidental and occurred at home (66.72%) and most (87.33%) were referred from primary health centers. Median time between event and arrival at primary care center was 1 hour while median time to arrival at the hospital was 11 hours. There were 89 deaths (mortality 15.03%) in the series. Male gender, rural residence, referred status and non-use of specific antidotes had negative impact on survival. Conclusion: This large prospective study from eastern India from a hospital perspective, has captured data not only on the incidence and nature of poisoning but also on treatment trends and mortality outcomes. Field studies conducted in the light of these results will clarify additional issues.
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Recruitment and retention of participants in clinical studies: Critical issues and challenges
Mira Desai
April-June 2020, 11(2):51-53
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Factors influencing recruitment and retention of participants in clinical studies conducted at a tertiary referral center: A five-year audit
Debdipta Bose, Shruti Saha, Unnati Saxena, Harshad Kesari, Urmila M Thatte, Nithya J Gogtay
April-June 2020, 11(2):81-85
Introduction: A key determinant of the success of any study is the recruitment and subsequent retention of participants. Screen failure and dropouts impact both the scientific validity and financial viability of any study. We carried out this audit with the objective of evaluating the recruitment and retention of participants in clinical studies conducted over the last five years at our center. Methods: Studies completed between 2014 and 2018 at our center were included. Screening ledgers and study trackers were hand searched for screen failures and dropouts. Four pre-identified predictors were evaluated – risk as per the classification of Indian Council of Medical Research 2017 Ethical Guideline, nature of funding, study design, and nature of participants. Association of the predictors with screen failures and dropouts was determined using crude odds ratios along with 95% confidence intervals. All analyses were done at 5% significance using Microsoft Excel 2016. Results: A total of n = 19 completed studies had n = 2567 screened and n = 2442 enrolled participants with a screen failure and dropout rate of 5% and 4%, respectively. We found 59% screen failures due to abnormal laboratory values. The main reasons for dropouts were lost to follow-up 86 (88%). High-risk and interventional studies were the predictors for both screen failures and dropouts, but pharmaceutical industry-funded studies and healthy participants were predictors for only screen failures. Conclusion: Risk, funding, study design, and nature of participants are important to be considered while planning studies to minimize screen failures and dropouts.
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Study designs: Part 7 – Systematic reviews
Priya Ranganathan, Rakesh Aggarwal
April-June 2020, 11(2):97-100
In this series on research study designs, we have so far looked at different types of primary research designs which attempt to answer a specific question. In this segment, we discuss systematic review, which is a study design used to summarize the results of several primary research studies. Systematic reviews often also use meta-analysis, which is a statistical tool to mathematically collate the results of various research studies to obtain a pooled estimate of treatment effect; this will be discussed in the next article.
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Effect of educational intervention on awareness of pharmacovigilance among medical undergraduates in a tertiary care teaching hospital
Mrunalini V Kalikar, Ganesh N Dakhale, Mayur Shrirao
April-June 2020, 11(2):92-96
Aim: (1) To assess the knowledge and attitude of undergraduates about adverse drug reaction (ADR) reporting at a tertiary care teaching hospital. (2) To assess the effect of educational intervention among medical undergraduates on knowledge and attitude about pharmacovigilance (PV). Materials and Methods: Cross-sectional, questionnaire-based survey conducted at a tertiary care teaching hospital. Respondents were 192 undergraduate students (2nd year). The study instrument was a self-developed, prevalidated semi-structured questionnaire. Participants were given 1 h to complete the questionnaire. After this, a 2 h lecture about PV was taken. Participants were asked to fill the same questionnaire after the educational intervention. Pre- and post-test questionnaire were compared. Results: There was an overall improvement in all three aspects, i.e., awareness, knowledge, and attitude. Most of the students had knowledge of the meaning of PV and reporting of ADR by doctors. However, there was a significant improvement in the knowledge regarding reporting of ADR by dentist, nurses, and pharmacist. Similarly, students were aware of the fact that ADR with allopathic medicines should be reported, but postintervention, there was improvement in percentage regarding reporting of ADR in the case of herbal and traditional medicine, blood products, and biological and medical device. There was a significant improvement in percentage regarding awareness about process of reporting ADR after exposure to lecture. Conclusion: There is a need of increasing awareness among the medical students to improve the reporting of ADRs. Adequate consideration needs to be given to the subject of ADRs in the clinical pharmacology and therapeutics curricula in undergraduate medical education.
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Erratum: Study designs: Part 5 – Interventional studies (III)

April-June 2020, 11(2):101-101
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