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   Table of Contents - Current issue
Coverpage
October-December 2021
Volume 12 | Issue 4
Page Nos. 177-237

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EDITORIAL  

Role of investigational new drug committees in propelling the drug development ecosystem in India p. 177
Sanish Davis
DOI:10.4103/picr.picr_190_21  
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SYSTEMATIC REVIEW Top

The state of cost-utility analysis in India: A systematic review p. 179
Tanu Khurana, Amit Gupta, Hemant Rathi
DOI:10.4103/picr.PICR_256_20  
Aims: Cost-utility studies are crucial tools that help policy-makers promote appropriate resource allocation. The objective of this study was to evaluate the extent and quality of cost-utility analysis (CUA) in India through a systematic literature review. Methods: Comprehensive database search was conducted to identify the relevant literature published from November 2009 to November 2019. Gray literature and hand searches were also performed. Two researchers independently reviewed and assessed study quality using Consolidated Health Economic Evaluation Reporting Standards checklist. Results: Thirty-five studies were included in the final review. Thirteen studies used Markov model, five used decision tree model, four used a combination of decision tree and Markov model and one each used microsimulation and dynamic compartmental model. The primary therapeutic areas targeted in CUA were infectious diseases (n = 12), ophthalmology (n = 5), and endocrine disorders (n = 4). Five studies were carried out in Tamil Nadu, four in Goa, three in Punjab, two each in Delhi, Maharashtra, and Uttar Pradesh, and one each in West Bengal and Karnataka. Twenty-three, eight, and four studies were found to be of excellent, very good, and good quality, respectively. The average quality score of the studies was 19.21 out of 24. Conclusions: This systematic literature review identified the published CUA studies in India. The overall quality of the included studies was good; however, features such as subgroup analyses and explicit study perspective were missing in several evaluations.
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REVIEW ARTICLES Top

Digital clinical trial: A new norm in clinical research p. 184
Sayanta Thakur, Sandeep Lahiry
DOI:10.4103/picr.PICR_278_20  
The advent of digital technologies has been well blended with every aspect of human lives. Despite not being a new concept, the adoption of digital health technologies in clinical research, i.e., digital clinical trial has not been utilized extensively. However, with the prevailing COVID-19 pandemics, such transformation in clinical trial seems imminent. Few components of a trial such as consent, remote site monitoring, recruitment process which can be modified through digital technologies, are further specified by the regulatory authorities such as FDA and EMA. However, such novel method cannot be implemented without facing any limitations. All stakeholders pertinent to virtual clinical trial including the provider of digital technologies should align themselves with the patient-centric approach to propagate this concept. It is expected that such a transition is well accomplished and adopted by the sponsors without any compromise in scientific as well as ethical standard.
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Building research capacity in India: The Masters in Clinical Research program at the Tata Memorial Centre p. 189
Durga Gadgil, Manju Sengar, CS Pramesh, Rajendra Badwe, Priya Ranganathan
DOI:10.4103/picr.picr_48_21  
Clinical research is an essential part of evidence-based medicine. The conduct of high-quality clinical research requires the backing of strong infrastructure, especially well-trained clinical research professionals. Tata Memorial Centre is the largest public cancer center in India and has been offering a Masters degree in Clinical Research since 2014. In this article, we look at the need for clinical research training, the evolution of this course and the impact it has had on clinical research capacity in India
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ORIGINAL ARTICLES Top

Determination of reference intervals from a laboratory database of an academic clinical research unit in a tertiary care teaching hospital and an audit of out of range values p. 193
Brinal H Figer, Jeffrey Pradeep Raj, Saket J Thaker, Nithya Jaideep Gogtay, Urmila Mukund Thatte
DOI:10.4103/picr.PICR_71_20  
Background: Abnormal laboratory values are a common reason for the exclusion of participants in clinical studies, increasing the recruitment time and cost during conduct. The use of sample-specific reference intervals (RIs) may help to address this issue. Hence, the present study derived site-specific RIs using the department laboratory database and compare the proportion of “out of range” (OOR) values between the new and the old RIs used by the trial site. Methods: Institutional ethics committee approval was obtained. Data for hematology and biochemistry parameters were analyzed. Normality was assessed and RIs computed using nonparametric method. Data were partitioned for gender and descriptive statistics applied for demographics. The OOR values based on new RIs were compared with old RIs using Chi-squared tests. Between gender OOR proportions compared using Chi-squared test (significance at P < 0.05). Post hoc analysis was performed with Beasley's technique. Results: Data of 601 participants were analyzed. The median (Inter Quartile Range) age was 22 (47) years and 64.72% were male. New RIs for key parameters were: Haemoglobin (9.3–16.5 g/dl), alanine aminotransferase (11.4–47.74 U/I), aspartate aminotransferase (8.8–58 U/I), total bilirubin (0.27–1.4 mg/dl), and creatinine (0.59–1.36 mg/dl). Post partitioning, the RI for hemoglobin (g/dl) was lower (8.72–15.72) in females. The proportion of OOR values were lower with new RIs relative to old laboratory RIs (P < 0.0001). Conclusion: A reduction in the proportion of OORs and a change in the upper and lower bound laboratory intervals with new RIs emphasize the need for sample-specific ranges to prevent unnecessary exclusions of volunteers from trials.
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A two-year evaluation of the minutes of Investigational New Drug committee meetings p. 199
Jeffrey Pradeep Raj, Nithya J Gogtay, Urmila M Thatte
DOI:10.4103/picr.PICR_83_19  
Introduction: The Investigational New Drug (IND) committee advises the Drug Controller General of India on matters pertaining to clinical trials (CTs) of IND for clinical development. An audit of the minutes of this committee's meetings would shed light on the drug discovery in India. Methods: Minutes of the IND committee meetings available in the public domain (2-year period) were evaluated. The applications which were postponed were excluded from the study. Outcome measures were therapeutic areas of IND, purpose of the applications, status of registration with the CT Registry of India (CTRI), and the innovator country. Results: The minutes of N = 7 meetings were available in the public domain for the period January 2017–December 2018 with N = 45 agenda items. One agenda item was excluded, and n = 44 agenda items were finally analyzed. The total number of therapeutic agents discussed was N = 29, of which n = 7/29 and n = 6/29 belonged to infectious diseases (ID) and oncology, respectively. The total number of purposes of these applications was N = 46, of which n = 35/46 (76%) were to seek permission to conduct a CT, and n = 31/35 (88.6%) were found registered with CTRI as on April 01, 2019. Of the N = 46 purposes, n = 33/46 (71.7%) were approved. Of the n = 29 INDs discussed, n = 19/29 (65.52%) were of the Indian origin. Conclusions: Although a majority (65%) of INDs discussed in the meetings were of the Indian origin, the drug discovery was not in line to tackle the top ten causes of years of life lost prematurely (barring ID).
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Drug use pattern for emergency psychiatric conditions in a tertiary care hospital: A prospective observational study p. 203
Sharmila V Jalgaonkar, Tausif I Mapara, Urwashi I Parmar, Mahesh L Patil, Shilpa Adarkar, Shubhangi Parkar
DOI:10.4103/picr.PICR_158_19  
Purpose: Psychiatric emergencies (PEs) are defined as acute disturbances of thought, mood, behavior, or social relationships requiring immediate interventions. The common emergency psychiatrics are attempted suicide, severe anxiety, schizophrenia, acute psychosis, substance abuse, acute panic attacks, drug toxicities, and extrapyramidal reactions. Emergency physicians in the general hospital may face the challenge of assessing and managing patients in PEs. This study was conducted to evaluate the clinical pattern and drug use pattern for PEs at a tertiary care hospital. Materials and Methods: This was a cross-sectional, observational study where patients presenting to emergency medical services of a tertiary care hospital were recruited after approval from Institutional Ethics Committee and written informed consent. Demographic details, diagnosis, medication details, cost of the treatment, and adherence to guidelines in the management of emergency psychiatric conditions were assessed using a validated questionnaire. Descriptive statistics was applied to analyze the data. Results: In 110 patients, a total number of drugs prescribed were 463 (mean: 4.21 drugs/prescription). The most commonly used psychotropic drug in emergency setting was found to be risperidone (19.39%), followed by lorazepam (13.60%) and clonazepam (4.28%). The most common diagnoses were substance abuse (32.72%) and schizophrenia (21.81%). About 74.5% of the physicians prescribed drugs abiding by the standard guidelines. The average total cost incurred by patients was about Rs. 366. Conclusion: The most commonly used drugs in emergency treatment found in this study are risperidone, followed by lorazepam and haloperidol.
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Immune response to hepatitis B vaccine: An evaluation p. 209
Anitha Madhavan, Dhanya Sasidharan Palappallil, Jayalakshmy Balakrishnapanicker, Anjana Asokan
DOI:10.4103/picr.PICR_119_19  
Background: Hepatitis B virus infection is a major public health problem in India, and all health-care workers (HCWs) need to be immunized to prevent occupational exposure. This study was done to find the hepatitis B vaccination rates, immune response, and predictors of titer <10 mIU/ml among students and HCWs of a tertiary care institution in the state of Kerala. Materials and Methods: This was a cross-sectional study conducted in the Department of Microbiology, Government TD Medical College, Alappuzha, Kerala, India, for a period of 1½ years between January 1, 2016, and June 30, 2017. Vaccination rates were collected through a screening proforma. Of the 1321 participants who filled the screening proforma, 5 ml of blood was collected aseptically from 579 participants who were fully vaccinated (all the three doses of vaccine) and stored at −20°C until antibody to hepatitis B surface antigen (anti-HBs) assay was done using Microlisa (Biorad). Data were analyzed using SPSS for Windows, version 16.0. (SPSS Inc., Chicago, IL, USA) (trial version). Statistical Analysis: Descriptive data were expressed using frequencies and percentages, and Chi-square test was applied to find the association between antibody titer <10 mIU/ml and independent variables. Results: Of the 1321 participants who filled up the screening proforma, the vaccination rate was 72.6%. Majority of the participants, i.e. 83.5% of doctors, 81.1% of nurses, 69.7% of students, and 21.4% of technicians, had taken all the three doses of hepatitis B vaccine. Of the fully vaccinated (n = 959) participants, 76.9% had the vaccination during adulthood and only 26.1% had it during childhood. The correlate of protection was defined as the presence of anti-HBs ≥10 mIU/ml. The mean antibody titer was 448 ± 284.97 mIU/ml ranging from 9.8 to 2000. Of the 579 participants whose titer was checked, 71 (12.3%) had a nonprotective titer of <10 mIU/ml. We found that age >35 (odds ratio [OR]: 3.85, 95% confidence interval [CI]: 2.12–6.99]), last dose >10 years (OR: 5.01, 95% CI: 2.94–8.55), no boosters or revaccination (OR: 2.94, 95% CI: 1.42–6.07), and body mass index (BMI) >25 (OR: 2.51, 95% CI: 1.44–3.39) were associated with nonprotective titer. Conclusion: More than a quarter of the study population who were at high risk of exposure were unvaccinated or partially vaccinated. Even after taking the full course of hepatitis B vaccine, 12.3% had titer <10 mIU/ml. Nonprotective titer was found to be associated with age >35 years, last dose taken >10 years ago, no boosters/revaccination, and BMI ≥25.
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Implementation of an educational program to promote research ethics in undergraduate medical students p. 216
Tejal C Patel, Raakhi K Tripathi, Tushar R Bagle, Nirmala N Rege
DOI:10.4103/picr.PICR_148_19  
Background: MBBS students lack training in research ethics which is crucial when they enter clinical practice and venture into clinical research in future. This study was planned to implement an educational module to build concepts in research ethics Objective: To assess the change in the knowledge and attitude of medical students towards research ethics. Methods: The study was initiated after obtaining institutional ethics committee approval. It was an interventional study, conducted on 2nd MBBS students (N=130) subjected to an educational program which comprised of three modules viz., theme lectures, educational visits and small group case based learning. A prevalidated questionnaire(35 items), was administered at baseline and at the end of 3 modules, to assess the change in the knowledge gained and in the attitude towards ethics in animal and human research. Feedback was obtained from students and faculty to assess the outcome of this program. Results: On analyzing the knowledge gained post intervention in 130 students, it was observed that in the post test for the items on ethics committee- need and composition, principles of research ethics was answered correctly by more number of students, which was statistically significant. The statistically significant positive change was observed for attitude of these students towards both animal and human research ethics. Case based discussions provided better understanding of ethical practices and its importance in conducting research as responded by majority students and faculty. Conclusions: Educational program on research ethics enhanced learning and brought about the positive attitudinal change. Majority students’ and faculty appreciated the program and considered it as relevant for undergraduate training.
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Comparison of efficacy, safety, and cost-effectiveness of sertaconazole and luliconazole cream in patients with dermatophytoses: A prospective, randomized, open-label study p. 223
Ganesh N Dakhale, Ashish V Gupta, Jayesh I Mukhi, Mrunalini V Kalikar
DOI:10.4103/picr.PICR_24_19  
Objective: To compare efficacy, safety, and cost-effectiveness of sertaconazole (2%) and luliconazole (1%) cream in patients with dermatophytoses. Materials and Methods: Sixty-four patients with tinea corporis and tinea cruris infections were enrolled in this single-center, randomized, open–label, parallel study. Following inclusion and exclusion criteria, patients were randomly divided into two treatment groups and received either sertaconazole 2% cream applied topically twice daily for 4 weeks and luliconazole 1% cream once daily for 2 weeks. At follow-up, efficacy was assessed clinically using 4-point physician global assessment (PGA) scale, composite score, and mycologically by KOH mount. Safety was assessed by monitoring adverse drug events at each visit. Results: The primary efficacy variables including changes in pruritus, erythema, vesicle, and desquamation (4-point PGA) were significantly (P < 0.0001) improved in both the groups, at the end of treatment. There was a significant reduction in mean total composite score (pruritus, erythema, vesicle, and desquamation) after the end of treatment in the sertaconazole group (P = 0.0002) compared to the luliconazole group. Both the groups showed equal negative mycological assessment. Both the study drugs were well tolerated. Only one patient in the sertaconazole group showed allergic contact dermatitis. Conclusion: Sertaconazole was better than luliconazole in relieving signs and symptoms during the study and follow-up period, but cost-effectiveness wise, luliconazole was better than sertaconazole.
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PUBLICATION PERSPECTIVE Top

Advice to authors for avoiding flaws in preparation of original research manuscripts p. 229
Arun Bhatt
DOI:10.4103/picr.PICR_139_21  
Preparation of manuscripts of original research for publication is the final and critical step in the conduct of clinical research. Most manuscripts are rejected because of flaws in design, methodology, interpretation, and writing. Understanding the reasons for rejection can help clinical researchers in avoiding common errors in all sections of manuscript – introduction, methods, results, and discussion. The article highlights the reasons for rejection of original research manuscripts and suggests approaches to improve the quality of the manuscript.
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BRIEF COMMUNICATIONS Top

Reasons for refusal among patients with tuberculosis and their household contacts to participate in an observational cohort study p. 234
Kalaivani Raghupathy, Selby Knudsen, Jerrold Ellner, Charles Horsburg, Natasha Hochberg, Padmini Salgame, Palanivel Chinnakali, Senbagavalli Prakashbabu, Sonali Sarkar
DOI:10.4103/picr.picr_377_20  
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Perception of Indian citizens toward the available COVID-19 vaccines: Need to create increased awareness p. 236
Anagha Hari Bharadwaj, Shobha Chikkavaddaragudi Ramachandra, Abhijith Devaraju, Suma M Nataraj, Prashant Vishwanath, Akila Prashant
DOI:10.4103/picr.picr_97_21  
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