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   2016| April-June  | Volume 7 | Issue 2  
    Online since March 31, 2016

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MicroRNA therapeutics: Discovering novel targets and developing specific therapy
Ajay Francis Christopher, Raman Preet Kaur, Gunpreet Kaur, Amandeep Kaur, Vikas Gupta, Parveen Bansal
April-June 2016, 7(2):68-74
DOI:10.4103/2229-3485.179431  PMID:27141472
MicroRNAs (miRNAs) are small non-coding RNA molecules that regulate gene expression in diverse biological process. They act as intracellular mediators that are necessary for various biological processes. MicroRNAs targeting pathways of human disease provide a new and potential powerful candidate for therapeutic intervention against various pathological conditions. Even though, the information about miRNA biology has significantly enriched but we still do not completely understand the mechanism of miRNA gene regulation. Various groups across the globe and pharmaceutical companies are conducting research and developments to explore miRNA based therapy and build a whole new area of miroRNA therapeutics. Consequently, few miRNAs have entered the preclinical and clinical stage and soon might be available in the market for use in humans.
  15,254 3,272 264
Common pitfalls in statistical analysis: The perils of multiple testing
Priya Ranganathan, CS Pramesh, Marc Buyse
April-June 2016, 7(2):106-107
DOI:10.4103/2229-3485.179436  PMID:27141478
Multiple testing refers to situations where a dataset is subjected to statistical testing multiple times - either at multiple time-points or through multiple subgroups or for multiple end-points. This amplifies the probability of a false-positive finding. In this article, we look at the consequences of multiple testing and explore various methods to deal with this issue.
  8,250 1,796 65
Phytopharmaceuticals: A new drug class regulated in India
Arun Bhatt
April-June 2016, 7(2):59-61
DOI:10.4103/2229-3485.179435  PMID:27141470
  7,877 1,493 17
Multi-regional clinical trials and global drug development
Premnath Shenoy
April-June 2016, 7(2):62-67
DOI:10.4103/2229-3485.179430  PMID:27141471
Drug development has been globalized, and multi-regional clinical trial (MRCT) for regulatory submission has widely been conducted by many discovery based global pharmaceutical companies with the objective of reducing the time lag of launch in key markets and improve patient access to new and innovative treatments. Sponsors are facing several challenges while conducting multiregional clinical trials. Challenges under the heads statistics, clinical, regulatory operational, and ethics have been discussed. Regulators in different countries such as USA, EU-Japan, and China have issued guidance documents in respect of MRCT's. Lack of harmonization in the design and planning of MRCT is perceived to create a difficult situation to sponsors adversely affecting progressing MRCT in more and more discoveries. International conference on hormonisation (ICH) has initiated the process for having a harmonized guidance document on MRCT. This document is likely to be issued in early 2017.
  6,713 956 25
Effectiveness of 3% hypertonic saline nebulization in acute bronchiolitis among Indian children: A quasi-experimental study
Harsh V Gupta, Vivek V Gupta, Gurmeet Kaur, Amitoz S Baidwan, Pardeep P George, Jay C Shah, Kushal Shinde, Ruku Malik, Neha Chitkara, Krushnan V Bajaj
April-June 2016, 7(2):88-93
DOI:10.4103/2229-3485.179434  PMID:27141475
Objective: To compare the effects of 3% hypertonic saline (HS) and 0.9% normal saline with nebulized 0.9% normal saline with salbutamol in patients of acute viral bronchiolitis. Materials and Methods: Participants were divided into three groups, that is, 3% HS group, 0.9% normal saline group and 0.9% saline with salbutamol group. Four doses at interval of 6 h were given daily until discharge. Average CS score and length of hospital stay were compared. One-way analysis of variance paired t-test and Chi-square test were utilized for statistical analysis. Results: The mean ages of the patients in three groups were 6.03 ± 3.71, 5.69 ± 3.34 and 5.48 ± 3.35 respectively. The 3rd day CS scores for all the groups were 1.0 ± 1.1, 1.9 ± 1.1 and 3.3 ± 0.5 respectively (P = 0.000). The average length of hospital stay was 3.4 ± 1.7, 3.7 ± 1.9 and 4.9 ± 1.4 days respectively (P = 0.001). Conclusion: The present study concludes that 3% HS nebulization (without additional bronchodilators) is an effective and safe treatment for nonasthmatic, moderately ill patients of acute bronchiolitis. The economic benefit of this comparably priced modality of treatment can be enormous in terms of hospital costs with parents returning to work sooner.
  5,996 781 5
A commentary on randomized clinical trials: How to produce them with a good level of evidence
Olga Dumont Flecha, Dhelfeson Willya Douglas de Oliveira, Leandro Silva Marques, Patricia Furtado Gonçalves
April-June 2016, 7(2):75-80
DOI:10.4103/2229-3485.179432  PMID:27141473
Randomized clinical trial (RCT) is the gold standard study for the evaluation of health interventions and is considered the second level of evidence for clinical decision making. However, the quality of the evidence produced by these studies is dependent on the methodological rigor employed at every stage of their execution. The purpose of randomization is to create groups that are comparable independent of any known or unknown potential confounding factor. A critical evaluation of the literature reveals that, for many years, RCTs have been developed based on inaccurate methodological criteria, and empirical evidence began to accumulate. Thus, guidelines were developed to assist authors, reviewers, and editors in the task of developing and assessing the methodological consistency of this type of study. The objective of this article is to review key aspects to design a good-quality RCT, supporting the scientific community in the production of reliable evidence and favoring clinical decision making to allow the patient to receive the best health care.
  5,588 665 4
Knowledge and perception regarding clinical trials among doctors of government medical colleges: A questionnaire-based study
Supriyo Choudhury, Richeek Pradhan, Lily Dubey, Lisa Barman, Tanmoy Biswas, Manisha Das, Suparna Chatterjee
April-June 2016, 7(2):94-99
DOI:10.4103/2229-3485.179433  PMID:27141476
Aims: By virtue of being a specialized field by itself, the science of clinical trials (CTs) may not be well understood by doctors who are not specifically trained in it. A lack of knowledge may translate to a negative perception toward CT. With the idea of getting a situational snapshot, we estimated the knowledge and perception of CTs among doctors from government medical colleges of West Bengal who are not trained on CT in their postgraduate curriculum. Several determinants of knowledge and perception regarding CT were also evaluated. Methods: We have quantified the knowledge and perception of CTs by a structured validated questionnaire. Development and validation of the questionnaire was performed prior to the study. Results: Among 133 participants, 7.5% received focused training on CT and 16.5% participated in CTs as investigators. Majority of the doctors were unfamiliar with the basic terminologies such as, “adverse event” and “good clinical practice.” Encouragingly, 93.3% doctors advised that a detailed discussion of CT methodology should be incorporated in the under graduate medical science curriculum. They had an overall positive attitude toward CTs conducted in India, with a mean score that is 72.6% of the maximum positive score. However, a large number of the doctors were skeptical about the primary motivation and operations of pharmaceutical industry sponsored CTs, with 45% of them believing that patients are exploited in these sponsored CTs. Conclusion: Participant doctors had a basic knowledge of CT methodology. The study has revealed specific areas of deficient knowledge, which might be emphasized while designing focused training on CT methodology.
  4,655 486 6
Understanding perception of chronic obstructive pulmonary disease among general practitioners, physicians, and pulmonologists in India: Results from a face-to-face survey
Ishpreet Kaur, Bhumika Aggarwal, Jaideep Gogtay
April-June 2016, 7(2):100-105
DOI:10.4103/2229-3485.179438  PMID:27141477
Background: Challenges exist in the diagnosis, management and follow-up of patients with chronic obstructive pulmonary disease (COPD) in India. Lack of awareness of the disease, its symptoms and its implications may significantly contribute in preventing individuals with symptoms from seeking advice from their primary care physicians or eliminating risk factors. This cross-sectional survey aimed to explore the attitudes, beliefs, and knowledge of doctors (general practitioners [GPs], physicians and pulmonologists) related to COPD recognition, diagnosis, and treatment in India. Methods: Data was collated from 91 randomly selected GPs, physicians and pulmonologists through a questionnaire and face-to-face interviews, in 8 cities of India. Results: The response rate to the survey was 68% (61 out of 91). Majority of the doctors (90% of GPs-physicians and 82% of pulmonologists) reported that patients with COPD visit them at moderate to severe stages of the disease. 44% of the GPs and physicians reported that they had never performed spirometry to make a diagnosis of COPD. About 35% of doctors reported that COPD occurred only in smokers. The most common reported barriers to the treatment of COPD were difficulty in explaining COPD to the patients, poor patient compliance to the prescribed treatment and the inability of patients to give up smoking. Most doctors agreed that compliance with treatment is a major concern in patients with COPD due to an ageing population, existence of limited therapeutic options and presence of comorbidities. Conclusion: The results of this cross-sectional survey of doctors in India, highlighted the need for increasing the awareness about COPD at both doctor and patients level to overcome the prevalent under-diagnosis and under-treatment in COPD.
  4,256 431 13
Opinions and perceptions regarding the impact of new regulatory guidelines: A survey in Indian Clinical Trial Investigators
Rashmi Kadam, Sanghratna Borde, Sapna Madas, Aarti Nagarkar, Sundeep Salvi, Sneha Limaye
April-June 2016, 7(2):81-87
DOI:10.4103/2229-3485.179437  PMID:27141474
Background: Clinical research in India experienced dramatic changes with series of stringent guidelines introduced by regulatory authorities. These guidelines posed significant challenges for the clinical trial industry. Objective: To assess the perceptions and opinion of Indian Investigators about the new regulatory guidelines. Methods: We developed a survey questionnaire on recent regulatory guidelines which was hosted on a web portal. Seventy-three investigators from India participated in the survey. Results: Central registration of Ethics Committees (ECs) was agreed by 90.1% participants, 76.8% participants agreed to compensation of subjects for study related Serious Adverse Events (SAE's). The compulsion to include government sites in clinical trials was not agreed by 49.3% participants while 21.2% agreed to it. Restriction on a number of trials per investigator was agreed by 49.3% of participants while 40.9% disagreed. Participants (50.7%) disagreed to the introduction of audio-video (AV) recording of informed consent, 36.6% agreed and 12.7% were neutral. Discussion: Participants observed that post central registration; ECs have improved systems with adequate member composition, functional Standard Operating Procedures, and timely approvals. Participants agreed that compensation of study related SAE's would assure subject protection and safety. The introduction of AV consenting was strongly debated sighting sociocultural issues in the implementation of the same. Conclusion: Participants endorsed guidelines pertaining to the central registration of ECs, SAE related compensation. Restrictions on a number of trials per investigator and AV consenting were debated ardently. The response of the survey participants who are clinical trial investigators in India showed general acceptance, effectiveness and anticipated compliance to the new regulatory guidelines.
  3,878 342 3