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Perspectives in Clinical Research

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https://www.readbyqxmd.com/read/28194338/development-of-medical-writing-in-india-past-present-and-future
#1
REVIEW
Suhasini Sharma
Pharmaceutical medical writing has grown significantly in India in the last couple of decades. It includes preparing regulatory, safety, and publication documents as well as educational and communication material related to health and health-care products. Medical writing requires medical understanding, knowledge of drug development and the regulatory and safety domains, understanding of research methodologies, and awareness of relevant regulations and guidelines. It also requires the ability to analyze, interpret, and present biomedical scientific data in the required format and good writing skills...
January 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28194337/development-of-statistics-as-a-discipline-for-clinical-research-past-present-and-future
#2
REVIEW
Chitra Lele
This article traces the history and evolution of statistics in the era of evidence based medicine, and focuses on the Indian perspective of this growth of statistics as a discipline for clinical research. Statistics will assume a more inter disciplinary form. Use of software other than SAS likely to grow further. In India, innovative statistical methods will help propel the development of biosimilars. The future is exciting with statistics being used for real world evidence, development of biosimilars, mining of adverse event data and becoming a core function in medicinal product development and lifecycle maintenance...
January 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28194336/clinical-research-a-personal-perspective
#3
REVIEW
Arun S Nanivadekar
Research ought to be inculcated as an attitude during the formative years of every health-care professional. The core elements of research are curiosity, observation, reasoning, and experimentation. These suggestions are supported with suitable examples. Medical advisers in the pharmaceutical industry are in a unique position to act as facilitators of such a process. The tools they can use are also suggested.
January 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28194335/investigators-viewpoint-of-clinical-trials-in-india-past-present-and-future
#4
REVIEW
Mohandas K Mallath, Tanuj Chawla
India's success in producing food and milk for its population (Green Revolution and White Revolution) happened because of scientific research and field trials. Likewise improving the health of Indians needs clinical research and clinical trials. A Large proportion of the sick Indians are poor, illiterate with no access to good health care. They are highly vulnerable to inducement and exploitation in clinical trials. The past two decades saw the rise and fall of clinical trials in India. The rise happened when our regulators created a favorable environment, and Indian investigators were invited to participate in global clinical trials...
January 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28194334/ethics-committees-in-india-past-present-and-future
#5
REVIEW
Urmila M Thatte, Padmaja A Marathe
: Following watershed amendments in Schedule Y India's star rose rather rapidly on the clinical research (especially clinical trials) horizon. Just as dramatic was the fall of this empire. At the centre of these events has been the participant and indirectly, the Ethics Committee (EC) that is established primarily to protect this individual. This paper traces the evolution of the concept of ECs in India, examines the current state of these committees in the country and suggests the way forward...
January 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28194333/ethics-committees-and-the-changed-clinical-research-environment-in-india-in-2016-a-perspective
#6
Sanish Davis, Poonam Sule, Murtuza Bughediwala, Vrunda Pandya, Shilpi Sinha
INTRODUCTION: Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs Standard Control Organization has in the period 2013-2016 introduced several new regulations and amendments to existing regulations overseeing the conduct of Research in India. Several of these have direct effect on the functioning of the EC from a review, approval, and oversight mechanism. METHODOLOGY: The Ethics Council of Indian Society for Clinical Research conducted a questionnaire survey among EC members to understand the impact of these changes in their functioning...
January 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28194332/regulatory-environment-for-clinical-research-recent-past-and-expected-future
#7
REVIEW
Amita Bhave, Suresh Menon
In the past few years, there have been numerous updates to policy and guidelines governing the conduct of clinical research in India. These measures were taken by regulators considering safety of Indian patients as the topmost priority although the overall regulatory environment became challenging. However, in the recent past, Indian regulations have evolved positively to favorably support clinical research in India while appropriately balancing patient safety as well. These regulatory changes are expected to bring newer innovative medicines to Indian patients at an earliest...
January 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28194331/-the-invisible-participant-s-experiences-in-clinical-trials
#8
Sarojini Nadimpally, Divya Bhagianadh
BACKGROUND: The paper discussing the perspectives of clinical trial participants about the various aspects of CTs is based on the primary research conducted by Sama in 2012-13. METHODOLOGY: In-depth interviews were conducted with 36 CT participants from the states of New Delhi, Gujarat, Maharashtra and Andhra Pradesh. In addition to CT participants, other key informants including investigators, representatives of Contract Research Organizations (CROs), sponsor, Ethics Committee (EC) members etc...
January 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28194330/future-of-indian-clinical-trials-moving-forward-from-hyped-potential-to-human-protection
#9
EDITORIAL
Arun Bhatt
No abstract text is available yet for this article.
January 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27843796/knowledge-about-clinical-trial-agreement-and-clinical-trial-related-insurance-among-ethics-committee-members-a-cross-sectional-survey
#10
Kannan Sridharan, Siddharth Deshpande, Subodh Sirur, Nithya J Gogtay, Urmila M Thatte
No abstract text is available yet for this article.
October 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27843795/common-pitfalls-in-statistical-analysis-the-use-of-correlation-techniques
#11
Rakesh Aggarwal, Priya Ranganathan
Correlation is a statistical technique which shows whether and how strongly two continuous variables are related. In this article, which is the eighth part in a series on 'Common pitfalls in Statistical Analysis', we look at the interpretation of the correlation coefficient and examine various situations in which the use of technique of correlation may be inappropriate.
October 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27843794/an-analysis-of-serious-adverse-drug-reactions-at-a-tertiary-care-teaching-hospital
#12
Kinjal Prajapati, Mira Desai, Samidh Shah, Jigar Panchal, Jigar Kapadia, Ramkumar Dikshit
OBJECTIVE: The objective of this study was to analyze the various aspects of serious adverse drug reactions (serious ADRs) such as clinical presentation, causality, severity, and preventability occurring in a hospital setting. MATERIALS AND METHODS: All serious ADRs reported from January 2010 to May 2015 at ADR Monitoring Centre, Department of Pharmacology, B. J. Medical College and Civil Hospital, Ahmedabad, were selected as per the World health Organization -Uppsala Monitoring Center (WHO-UMC) criteria...
October 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27843793/evaluation-of-performance-of-the-medical-research-department-in-research-naive-non-academic-hospital-an-audit
#13
Mukta Sunil Kuyare, Parag Vijayrao Sarve, Komal S Dalal, Raakhi K Tripathi
INTRODUCTION: Conducting medical research is not limited to academia and pharmaceutical industry but even multispeciality hospitals need to venture in this area along with patient care. To develop research culture among well-established non-acedemic hospital is always difficult and challenging task. This article attempts to evaluate the performance of the department in 'Research naïve' hospital in the last two years and review the strengths and challenges it faced at each step. METHODS: This was a retrospective document analysis study evaluating the steps towards setting and sustaining of Medical Research Department of Bhaktivedanta Hospital during the period of January 2013 to June 2015 (30 Months)...
October 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27843792/a-study-of-medication-errors-in-a-tertiary-care-hospital
#14
Nrupal Patel, Mira Desai, Samdih Shah, Prakruti Patel, Anuradha Gandhi
OBJECTIVE: To determine the nature and types of medication errors (MEs), to evaluate occurrence of drug-drug interactions (DDIs), and assess rationality of prescription orders in a tertiary care teaching hospital. MATERIALS AND METHODS: A prospective, observational study was conducted in General Medicine and Pediatric ward of Civil Hospital, Ahmedabad during October 2012 to January 2014. MEs were categorized as prescription error, dispensing error, and administration error (AE)...
October 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27843791/an-audit-of-the-approval-letters-issued-by-drugs-controller-general-of-india-to-ethics-committees-in-india
#15
Shruti S Bhide, Jahnavi V Katkar, Mitesh Maurya, Nithya Jaideep Gogtay, Urmila M Thatte
AIM: The present study is an audit of the communiqués issued by the Drugs Controller General of India [DCGI] to Ethics Committees [ECs] for content and directives after the mandatory notification of registration of Ethics Committees issued on 8(th) February 2013. METHODS: All letters were downloaded from the website of the Central Drugs Standard Control Organization [CDSCO] and evaluated for the date of issue, number of directives, domains covered by the directives [general instructions, administrative requirements and quorum requirements], median time to approval for registration and time elapsed between date of application and issue of the approval letter...
October 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27843790/trends-in-clinical-trials-of-dengue-vaccine
#16
REVIEW
Priya Marimuthu, Jamuna Rani Ravinder
Dengue is one of the most important vector-borne disease and an increasing problem worldwide because of current globalization trends. Roughly, half the world's population lives in dengue endemic countries, and nearly 100 million people are infected annually with dengue. India has the highest burden of the disease with 34% of the global cases. In the context of an expanding and potentially fatal infectious disease without effective prevention or specific treatment, the public health value of a protective vaccine is clear...
October 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27843789/real-world-evidence-an-indian-perspective
#17
REVIEW
Amit Dang, B N Vallish
Randomized controlled trials (RCTs) are the gold standard for measuring the safety and efficacy of drugs. However, they are being challenged by payers and health care providers since they are looking for real world evidence (RWE) to validate whether the new intervention provides similar safety and efficacy as reported in RCT data. RWE uses real world data (RWD) to generate insight, foresight, and explorative findings on diseases, products, and patient populations. There are varied sources of RWD such as administrative data, large pragmatic trials, registries, electronic health records, and health surveys...
October 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27843788/involvement-of-general-public-in-biomedical-research
#18
C S Pramesh, R Venkataramanan, Viraj Suvarna, Nishu Singh Goel, S Lakshman, Viji Venkatesh, Vandana Gupta, Rajendra Badwe
Biomedical research is crucial for any country's progress and the health of its ethnic population. This effort needs to be sustained and well supported for it to bear optimum results. The major stakeholders in medical research are the general public, patients, researchers, physicians (and medical institutions), the pharmaceutical industry, regulatory authorities, and the government. Much of the pressure to perform cutting edge research in developed countries is driven by the general public; however, this has been conspicuous by its absence in India...
October 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27843787/are-registered-ethics-committees-empowered-to-ensure-human-research-protection
#19
EDITORIAL
Arun Bhatt
No abstract text is available yet for this article.
October 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27453833/single-versus-double-masking-in-glaucoma-clinical-trials
#20
D L DeMill, Barbara M Wirostko, Lindsay A Nelson, Jeanette A Stewart, William C Stewart
No abstract text is available yet for this article.
July 2016: Perspectives in Clinical Research
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