Perspectives in clinical research (Perspect Clin Res )


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Publications in this journal

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    ABSTRACT: Randomized control trials and its meta-analysis has occupied the pinnacle in levels of evidence available for research. However, there were several limitations of these trials. Network meta-analysis (NMA) is a recent tool for evidence-based medicine that draws strength from direct and indirect evidence generated from randomized control trials. It facilitates comparisons across multiple treatment options, direct comparisons of which have not been attempted till date due to multitude of reasons. These indirect treatment comparisons of randomized controlled trials are based on similarity and consistency assumptions that follow Bayesian or frequentist statistics. Most NMAuntil date use Microsoft Windows WinBUGs Software for analysis which relies on Bayesian statistics. Methodology of NMA is expected to undergo further refi nements and become robust with usage. Power and precision of indirect comparisons in NMA is a concern as it is dependent on effective number of trials, sample size and complete statistical information. However, NMA can synthesize results of considerable relevance to experts and policy makers.
    Perspectives in clinical research 10/2014; 5(4):154-8.
  • Perspectives in clinical research 07/2014; 5(3):139-40.
  • Perspectives in clinical research 07/2014; 5(3):141.
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    ABSTRACT: 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.
    Perspectives in clinical research 07/2014; 5(3):95-9.
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    ABSTRACT: The clinical SAS ( 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.
    Perspectives in clinical research 07/2014; 5(3):125-8.
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    ABSTRACT: 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.
    Perspectives in clinical research 07/2014; 5(3):108-14.
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    ABSTRACT: 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.
    Perspectives in clinical research 07/2014; 5(3):100-7.
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    ABSTRACT: 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.
    Perspectives in clinical research 07/2014; 5(3):115-20.
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    ABSTRACT: 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.
    Perspectives in clinical research 07/2014; 5(3):121-4.
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    ABSTRACT: 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.
    Perspectives in clinical research 07/2014; 5(3):129-33.
  • Perspectives in clinical research 07/2014; 5(3):93-4.
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    ABSTRACT: Sponsors need to pay for management of all serious adverse events suffered by subjects in a clinical trial and to compensate for injuries or deaths related to the trial. This study examines if insurance policies of trials, cover all contingencies that require reimbursement or compensation.
    Perspectives in clinical research 01/2014; 5(4):145-150.
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    ABSTRACT: Asthma is a common chronic inflammatory disease of the bronchial airways. Well defined treatment options for asthma are very few. The role of vitamin D3 on asthma is still baffling. AIM: We have examined the effect of vitamin D3 supplementation in mild to moderate persistent asthma patients.
    Perspectives in clinical research 01/2014; 5(4):167-171.
  • Perspectives in clinical research 01/2014; 5(4):195-196.
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    ABSTRACT: Obtaining negative or contradicting results, whereas conducting a study has always been overlooked as inadequacies on the part of the researcher. Many-a-times, negative results are arrived at even after conducting the study with great care and effort. This cannot be considered, a flaw, always. Contradicting results may be arrived at because of various reasons and should be considered and published in order to arrive at a definitive result. Various journals are available which publish these contradicting results exclusively. It is the duty of the researcher to know in detail the cause and effect of these, considering the pros and cons. This article gives a bird's eye view of when, where and how to manage negative or contradicting results of a study.
    Perspectives in clinical research 01/2014; 5(4):151-153.
  • Perspectives in clinical research 01/2014; 5(4):197.