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   2014| July-September  | Volume 5 | Issue 3  
    Online since June 11, 2014

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Ethics reporting practices in clinical research publications: A review of four Indian journals
Mahesh N Belhekar, Supriya S Bhalerao, Renuka P Munshi
July-September 2014, 5(3):129-133
DOI:10.4103/2229-3485.134316  PMID:24987584
Background: Manuscript authors of scientific journals are expected to report if their studies were conducted according to international and national ethical guidelines and inform readers regarding ethics approval and informed consent obtained from participants and/or their legally acceptable representative/s. In the present study we assessed the reporting practices of ethics approval and informed consent (assent in case of pediatric studies) in four Indian journals. Materials and Methods: Original research articles published over a period of 4 years (2009-2012) in four major national clinical journals, viz. Journal of Association of Physicians of India (JAPI), Indian Journal of Surgery (IJS), Journal of Obstetrics and Gynecology of India (JOGI), and Indian Journal of Orthopedics (IJO) were reviewed with regard to documentation of ethics approval and written informed consent and assent in case of pediatric participants. Results: We reviewed 673 research articles and found that, overall ethical approval was mentioned in 163 (24.2%) and informed consent or assent was mentioned in 179 (26.5%) articles in all four journals. Individually we found, in JAPI of the 174 manuscripts reviewed, 74 (42.5%) reported having obtained approval from the ethics committee and 68 (39.1%) reported taking written informed consent from participants. In IJS of 123 manuscripts, 18 (14.6%) reported ethics committee approval and 20 (16.2%) reported informed consent from participants. In JOGI of 152 manuscripts, 21 (13.8%) reported ethics committee approval while 49 (32.2%) reported informed consent from participants. In IJO, of 224 manuscripts, 50 (22.3%) reported ethics committee approval and 42 (18.7%) reported obtaining informed consent. Conclusion: Majority of the publications did not provide information regarding compliance to ethical guidelines in spite of the availability of various guidelines. Thus, there is a need for awareness and training on bioethics for authors, reviewers, and editors of biomedical journals.
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India's next challenge: Rebooting recruitment
Arun Bhatt
July-September 2014, 5(3):93-94
DOI:10.4103/2229-3485.134295  PMID:24987577
  3 1,701 376
Analysis of data query as parameter of quality
Sonia Khatawkar, Arun Bhatt, Rutika Shetty, Patricia Dsilva
July-September 2014, 5(3):121-124
DOI:10.4103/2229-3485.134312  PMID:24987582
Introduction: Data query (DQ) rate per case record form (CRF) page is an index of quality of clinical trial data, which can be affected by the phase of clinical trial, the therapeutic area, and the country, where investigator site is located. Objective: To compare DQ rate per page by countries, phases, and therapeutic areas. Materials and Methods: Data from 19 paper CRF clinical trials conducted at 352 sites, in 5,610 patients were entered into clinical data management system by double data entry method, and DQs were generated. The DQ rate per page was compared for the phase, therapeutic area, and the country, by parametric analysis of variance (ANOVA) and nonparametric test-Kruskal-Wallis and median test. Multiple comparisons test was conducted for each category using Tukey's Studentized Range Test. Results: The total number of DQs from 108,599 CRF pages was 33,177 (0.306/CRF page). The studies included 12 countries, all phases, and seven therapeutic areas. Comparison of DQ rate per page showed a significant difference between phases, countries, and therapeutic areas. However, multiple comparisons showed that the DQ rate per page was significantly different between Phase I and other phases, and oncology, cardiology, endocrinology, and dermatology. The DQ categories were: Missing 21.8%, confirmatory 50.1%, and clarification 28.2%. The most common DQs by CRF field were: Lab data (23.2%), physical examination (17.4%), study assessment (17.4), and concomitant medication (12%). There was no correlation between the number of CRF pages and DQ rate per page per study. Conclusion: The phase of study and therapeutic area could impact the data quality as measured by DQ rates.
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Glaucoma clinical trial design: A review of the literature
William C. Stewart, Jeanette A. Stewart, Lindsay A. Nelson
July-September 2014, 5(3):108-114
DOI:10.4103/2229-3485.134306  PMID:24987580
The purpose of this article is to review the prior research evaluating design techniques for glaucoma clinical trials to help ophthalmologists and pharmaceutical sponsors better develop literature-based studies that are cost- and time-efficient. We performed this study using known published articles by the authors and literature found on Pub Med. We included 24 articles that analyzed specifically the results of clinical trial methods and/or interpretation. This review found that studies have evaluated glaucoma specific aspects of glaucoma clinical trials including: Predicting the results of later phase clinical trials based on early phase clinical trials and animal studies; protocol design parameters such as intraocular pressure, inclusion criteria, method of pressure measurement, study population, and side effect evaluation; and study planning issues such as number of clinical sites as well as subjects, dropout rates, estimated serious adverse events, and protocol violations. This review suggests that the medical literature supports some aspects of glaucoma clinical trial study design. Additional design features might be derived from government regulations, guidance, as well as agency contacts, consultants, and clinical community standards. Study design decisions that must be made beyond the aforementioned resources should be made carefully, with appropriate consultation as needed, considering the risk/benefit ratio to the study. However, more research is needed to better evaluate the design procedures and methods involved in glaucoma clinical trials to best provide a cost- and time-efficient study while achieving quality efficacy and safety results.
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Matching in case control studies - A comment on the Revised National Tuberculosis Control Program regimens with and without directly observed treatment, short-course: A comparative study of the therapeutic cure rate and adverse reactions
Kanica Kaushal, Sunil K. Raina
July-September 2014, 5(3):141-141
DOI:10.4103/2229-3485.134324  PMID:24987587
  - 1,289 208
Author's reply
Rengaraj Sivaraj, Sivaraj Umarani, Subramani Parasuraman, Pyapti Muralidhar
July-September 2014, 5(3):141-142
  - 1,136 194
Serological response to one intradermal or intramuscular hepatitis B virus vaccine booster dose in human immunodeficiency virus-infected nonresponders to standard vaccination
Amitis Ramezani, Alireza Janbakhsh, Maryam Gol-Mohammadi, Mohammad Banifazl, Arezoo Aghakhani, Ali Eslamifar, Zahra Pournasiri, Behzad Mahdavian, Ali-Asghar Farazi, Masoomeh Sofian
July-September 2014, 5(3):134-138
DOI:10.4103/2229-3485.134318  PMID:24987585
Purpose : Hepatitis B virus (HBV) vaccination is recommended for all human immunodeficiency virus (HIV)-infected patients without HBV immunity. However, serological response to standard HBV vaccination is frequently suboptimal in this population and the appropriate strategy for revaccination of HIV-infected nonresponders remained controversial. We aimed to determine the serological response to one booster dose of HBV vaccine given by intradermal (ID) or intramuscular (IM) route in HIV-positive nonresponders to standard HBV vaccination. Materials and Methods : In this study, 42 HIV-infected nonresponders were enrolled. We randomized them to receive either 10 μg (0.5 mL) for ID (20 cases) or 20 μg (1 mL) for IM (22 cases) administration of HBV vaccine as a one booster dose. After 1 month, anti-HBs titer was checked in all cases. A protective antibody response (seroconversion) defined as an anti-HBs titer ≥10 IU/L. Results: Seroconversion was observed in 47.6% of subjects after 1 ID dose. A total of 30% showed antibody titers above 100 IU/L. Except one case, all responders had CD4 + >200 cells/mm 3 . Mean anti-HBs titer was 146.5 ± 246 IU/L. After the one IM booster dose, seroconversion was observed in 50% of cases. A total of 36.3% of subjects had anti-HBs ≥100 IU/L. All responders had CD4 + >200 cells/mm 3 , except one case. Mean anti-HBs titer was 416.4 ± 765.6 IU/L. Responders showed significantly higher CD4 + cell counts, in comparison to nonresponders (P < 0.001). Conclusions: One booster dose administered IM or ID to HIV-infected nonresponders resulted in similar rates of seroconversion, overall response rate 50%. However, higher anti-HBs titers observed more frequently in IM group.
  - 2,248 295
An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study
Subhrojyoti Bhowmick, Koyel Banerjee, Shreya Sikdar, Tapan Kumar Chatterjee
July-September 2014, 5(3):115-120
DOI:10.4103/2229-3485.134310  PMID:24987581
Purpose of study: The vital responsibility of Institutional Ethics Committee (IEC) members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. Materials and Methods: A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals) in Kolkata conducting active clinical research and having functional Ethics Committees (ECs) in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to all EC members through telephone/e-mail for completion and returning of the forms. The filled in forms were returned to their respective Member Secretaries, from whom authors' collected the forms. Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Categorical data were analyzed using Chi-square test and a P < 0.05 was considered statistically significant. Results: Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly. Overall awareness regarding different pharmacovigilance terminologies and activities among EC members from nonmedical background (71.43%) was found to be more than that of the medical members (68.75%), though the figure was not statistically significant. Majority of the members (75%) felt that EC should decide compensation in case of a serious adverse event. Conclusion: The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding pharmacovigilance activities conducted during clinical trials; and, hence the functioning of the ECs to safeguard the safety of patients during clinical trials remains questionable. There is a definite need for immediate intervention in the form of mandatory training hours for EC members about pharmacovigilance activities and reporting timelines to ensure clinical trial s ubject safe t y in the long run.
  - 2,745 378
Clinical SAS programming in India: A study of industry needs versus wants
Nithiyanandhan Ananthakrishnan
July-September 2014, 5(3):125-128
DOI:10.4103/2229-3485.134314  PMID:24987583
Background: The clinical SAS (www.sas.com) programming industry, in India, has seen a rapid growth in the last decade and the trend seems set to continue, for the next couple of years, due to cost advantage and the availability of skilled labor. On one side the industry needs are focused on less execution time, high margins, segmented tasks and the delivery of high quality output with minimal oversight. On the other side, due to the increased demand for skilled resources, the wants of the programmers have taken a different shift toward diversifying exposure, unsustainable wage inflation due to multiple opportunities and generally high expectations around career progression. If the industry needs are not going to match with programmers want, or vice versa, then there is the possibility that the current year on year growth may start to slow or even go into decline. Aim: This paper is intended to identify the gap between wants and need and puts forwards some suggestions, for both sides, in ways to change the equation to benefit all. Settings and Design: Questionnaire on similar themes created to survey managers and programmers working in clinical SAS programming industry and was surveyed online to collect their perspectives. Their views are compared for each theme and presented as results. Materials and Methods: Two surveys were created in www.surveymonkey.com. Management: https://www.surveymonkey.com/s/SAS_India_managment_needvswant_survey. Programmer: https://www.surveymonkey.com/s/SAS_India_programmer_needvswant_survey. Statistical Analysis Used: Bar chart and pie chart used on data collect to show segmentation of data. Results and Conclusions: In conclusion, it seeks to highlight the future industry direction and the skillset that existing programmers need to have, in order to sustain the momentum and remain competitive, to contribute to the future pipeline and the development of the profession in India.
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Indian Regulatory Update: Jan-May 2014
Kedar Suvarnapathaki
July-September 2014, 5(3):139-140
DOI:10.4103/2229-3485.134322  PMID:24987586
  - 1,588 384
Competent statistical programmer: Need of business process outsourcing industry
Imran Khan
July-September 2014, 5(3):95-99
DOI:10.4103/2229-3485.134300  PMID:24987578
Over the last two decades Business Process Outsourcing (BPO) has evolved as much mature practice. India is looked as preferred destination for pharmaceutical outsourcing over a cost arbitrage. Among the biometrics outsourcing, statistical programming and analysis required very niche skill for service delivery. The demand and supply ratios are imbalance due to high churn out rate and less supply of competent programmer. Industry is moving from task delivery to ownership and accountability. The paradigm shift from an outsourcing to consulting is triggering the need for competent statistical programmer. Programmers should be trained in technical, analytical, problem solving, decision making and soft skill as the expectations from the customer are changing from task delivery to accountability of the project. This paper will highlight the common issue SAS programming service industry is facing and skills the programmers need to develop to cope up with these changes.
  - 2,836 360
Expert committee to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs-comments
Ravindra B. Ghooi
July-September 2014, 5(3):100-107
DOI:10.4103/2229-3485.134304  PMID:24987579
All is not well with the clinical research industry. Instances of scientific misconduct by investigators, cutting corners by sponsors, irregularities by regulators, have brought a bad name to the industry. These however form a small part of the clinical research done in this country. The US FDA has conducted over 40 audits, and not made any major observations, suggesting that the clinical research in India is by and large above board. Regulators have amended trial rules recently which have cost the industry dear. A committee appointed to formulate the policy and guidelines for approval of new drugs, clinical trials and banning of the drugs has made 25 recommendations of which most are either superfluous or not likely produce the desired effect. Clubbing banning of the drugs with approval of new drugs and clinical trials also does not make sense, since the mechanisms involved are totally different. Barring a few, most recommendations are counterproductive and should be rejected outright. It is time we learnt that appointment of a committee is not the best way to solve a problem.
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