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Perspectives in Clinical Research

Suhasini Sharma
No abstract text is available yet for this article.
January 2019: Perspectives in Clinical Research
Francesco Chirico, Nicola Magnavita
No abstract text is available yet for this article.
January 2019: Perspectives in Clinical Research
Viraj Suvarna, Jignesh Ved
No abstract text is available yet for this article.
January 2019: Perspectives in Clinical Research
Goraj Desai
English, the most widely used and accepted language worldwide, is also the dominant language in scientific writing. To ensure that a publication has a wide reach, it should be written in a simple and concise manner, which requires a good command over the English language. However, this is an area of challenge for most medical writers in India. This article includes tips and tools that will help medical writers overcome these challenges, which will aid in better understanding of the audience and easier publication process...
January 2019: Perspectives in Clinical Research
Rakesh Aggarwal, Priya Ranganathan
One of the first steps in planning a research study is the choice of study design. The available study designs are divided broadly into two types - observational and interventional. Of the various observational study designs, the descriptive design is the simplest. It allows the researcher to study and describe the distribution of one or more variables, without regard to any causal or other hypotheses. This article discusses the subtypes of descriptive study design, and their strengths and limitations.
January 2019: Perspectives in Clinical Research
Amita Bhave, Lakhvinder Singh Batolar
This document provides updates in regulatory requirements regarding conduct of clinical trials in India.
January 2019: Perspectives in Clinical Research
Amit R Birajdar, Debdipta Bose, Tushar B Nishandar, Anagha A Shende, Urmila M Thatte, Nithya J Gogtay
Background: The Clinical Trials Registry of India (CTRI) was launched in July 2007 and will enter its tenth year in 2017. While its mission is to encourage prospective trial registration, CTRI does permit retrospective trial registration. Against this backdrop, the present audit was carried out with the primary objective of assessing the nature and extent of trials retrospectively registered with CTRI. Methods: All studies registered in the year 2016 were searched within CTRI using the keyword "CTRI/2016...
January 2019: Perspectives in Clinical Research
Kasturi Awatagiri, Durga Gadgil, Sadhana Kannan, Pallavi Rane, Bhavesh Bandekar, Nilam Sawant, Prafulla Parikh, Vedang Murthy
Context: Adherence to good clinical practice (GCP) guidelines by the researcher provides public confidence that the rights, safety and well-being of human participants involved in research are protected. It has been observed that researchers require basic GCP training. Considering this, we had decided to conduct a training session on overview of GCP. Aims: To strengthen the knowledge and awareness regarding GCP. Settings and Design: The design of the study was quasi-experimental one group, pre-test and post-test design and the study was conducted at ACTREC among healthcare professionals at Tata Memorial Centre...
January 2019: Perspectives in Clinical Research
Parvan A Shetty, Nithya J Gogtay, Urmila M Thatte
Background: In January 2015, the Drugs Controller General of India approved the formation of 25 Subject Expert Committees [SEC] to aid the office of the Central Drugs Standard Control Organization [CDSCO] with regards to decision making. The present study is an audit of the minutes of the meetings the SECs held over the past three years. Methods: All minutes during the period 1st July 2014 to 31st October 2017 were accessed from the CDSCO website. Applications were classified as those for clinical trials [CT] and those for marketing authorization [MA]...
January 2019: Perspectives in Clinical Research
Mahesh Ravindra Khairnar, Umesh Wadgave, Sagar Jatish Shah, Swarali Shah, Vardhaman Mulchand Jain, Sagar Kumbhar
Purpose: Plagiarism is a type of research misconduct that consists of copying other's work or ideas without giving them proper credit. The rise of plagiarism cases has become a serious concern in the scientific world. Hence, a cross-sectional survey was carried out to assess the attitude among dental faculty members and postgraduate (PG) students toward plagiarism. Objectives were to compare the attitudes of dental faculty members and PG students toward plagiarism and to analyze the association of attitude toward plagiarism (ATP) with age, gender, and number of publications of the participants...
January 2019: Perspectives in Clinical Research
Gaurav Anand, Mohit Joshi
Publications in peer-reviewed journals as well as oral and poster presentations for scientific conferences comes under the purview of GPP3 guideline. The GPP3 has kept pace with the changes in publication practices and focusses on every burning aspect of publications. The present paper evaluates the purview of GPP3 guideline in context with the evolving role of medical writer (MW) in the present times. A MW plays an important role to in producing high quality authentic documents. The role of professional MW have previously been emphasised upon in previous versions of GPP guidelines, and have been instrumental in acknowledging role of MWs in medical publications and cementing their existence rather than them being termed as 'ghostwriters'...
January 2019: Perspectives in Clinical Research
Amita Bhave, Suresh Menon
No abstract text is available yet for this article.
January 2019: Perspectives in Clinical Research
Gerard Marshall Raj
No abstract text is available yet for this article.
October 2018: Perspectives in Clinical Research
Priya Ranganathan, Rakesh Aggarwal
There are several types of research study designs, each with its inherent strengths and flaws. The study design used to answer a particular research question depends on the nature of the question and the availability of resources. In this article, which is the first part of a series on "study designs," we provide an overview of research study designs and their classification. The subsequent articles will focus on individual designs.
October 2018: Perspectives in Clinical Research
Mahanjit Konwar, Debdipta Bose, Nithya J Gogtay, Urmila M Thatte
Investigator-initiated studies (IISs) help by generating data on effectiveness and safety of a drug in the real-world setting and attempt to answer questions that clinicians face in their day-to-day practice. These are studies that are initiated and managed by a nonpharmaceutical company researcher/s who could be an individual investigator, an institution or a group of institutions, and a collaborative study group or a cooperative group. They are largely driven by questions that arise beyond the completion of Phase III studies that have not been studied during Phases I-III of drug development...
October 2018: Perspectives in Clinical Research
Bikash Ranjan Meher
Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices and protection of patient's health by preventing its recurrences. Postmarketing surveillance of medical devices has been initiated in many countries, but it is still not as developed and robust as that of medicines. Materiovigilance program of India was launched on July 6, 2015, at Indian Pharmacopeia Commission with objectives to track the adverse events associated with the use of medical devices, to generate safety data, create awareness among the different stakeholders, and recommend the best practices and interventions to improve the patient's safety...
October 2018: Perspectives in Clinical Research
Mohit Hans, Suresh Kumar Gupta
The primary focus of the pharmacovigilance (PV) practice has been on the collection, assessment, and reporting of the adverse drug reactions to medicinal products. Globalization of the pharmaceutical industry has prompted efforts to toward harmonization of PV practices worldwide to enable improved knowledge of medicine's benefit-risk profile and risk communication. Even as PV has evolved over the past decade, there still exist few areas of discordance across global PV practices. This article compares the PV legislation in the United States, United Kingdom, Canada, and India with a view to understand areas of harmony in the current legislation across regions and further compare health authorities' requirements with recommendations made by international organizations...
October 2018: Perspectives in Clinical Research
Kiran Gordhanbhai Piparva, Gaurav Jansari, Anil P Singh
Background: The emergence of drug-resistant mycobacteria becomes a significant public health problem globally creating an obstacle to effective tuberculosis (TB) control. Gujarat, Maharashtra, and Andhra Pradesh DRS survey estimated that the proportion of multidrug-resistant TB (MDR-TB) is 2.1% (in new TB cases) and 15% (in previously treated cases). Programmatic management of MDR-TB implemented under Revised National Tuberculosis Control Programme in India in 2007. Objectives: The objective of this study is to evaluate treatment outcome and adverse drug reactions (ADRs) of category IV...
October 2018: Perspectives in Clinical Research
Swapnil Narayan Deshmukh, Vandana Avinash Badar, Manali Mangesh Mahajan, D Sujata Dudhgaonkar, Dharmendra Mishra
Background: Topical retinoids in combination with antimicrobials have been proven to reduce acne lesions faster and to a greater degree than antimicrobial therapy alone . Aims and Objectives: To compare the efficacy and safety of topical combination of 1% Nadifloxacin [NAD] and 0.025% Tretinoin [Tr] with 1% Clindamycin [CLN] and 0.025% Tr in patients of mild to moderate acne vulgaris of the face. Material and Methods: There were two groups (40 patients in each group): Group A received (NAD+Tr) combination therapy and group B received (CLN+Tr) combination therapy...
October 2018: Perspectives in Clinical Research
Pradeep Gadge, Roshani Gadge, Nikita Paralkar, Preeti Jain, Vrunda Tanna
Introduction: Telmisartan is one of the preferred choices of antihypertensive in patients of diabetes with hypertension (HTN) and lowers blood pressure (BP) effectively. Objective: The objective of the study was to determine BP-lowering efficacy of telmisartan monotherapy in patients of Stage I HTN with or without complications of type 2 diabetes mellitus (T2DM). Materials and Methods: In this retrospective study, patients of T2DM without (Group A) or with (Group B) complications who had Stage I HTN and were prescribed telmisartan (20-80 mg/day) treatment were identified from database...
October 2018: Perspectives in Clinical Research
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