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Perspectives in Clinical Research

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https://www.readbyqxmd.com/read/27843796/knowledge-about-clinical-trial-agreement-and-clinical-trial-related-insurance-among-ethics-committee-members-a-cross-sectional-survey
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
https://www.readbyqxmd.com/read/27453832/common-pitfalls-in-statistical-analysis-intention-to-treat-versus-per-protocol-analysis
#12
Priya Ranganathan, C S Pramesh, Rakesh Aggarwal
During the conduct of clinical trials, it is not uncommon to have protocol violations or inability to assess outcomes. This article in our series on common pitfalls in statistical analysis explains the complexities of analyzing results from such trials and highlights the importance of "intention-to-treat" analysis.
July 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27453831/challenges-in-recruitment-and-retention-of-clinical-trial-subjects
#13
Rashmi Ashish Kadam, Sanghratna Umakant Borde, Sapna Amol Madas, Sundeep Santosh Salvi, Sneha Saurabh Limaye
BACKGROUND: Successful recruitment of patients is known to be one of the most challenging aspects in conduct of randomized controlled trials. Inadequate patient retention during conduct of trial affects conclusive results. OBJECTIVE: To assess the level of challenges faced by Indian investigators in recruitment and retention of trial subjects. METHODS: We developed a survey questionnaire on challenges encountered by investigators in subject recruitment and retention which was hosted on a web portal...
July 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27453830/assessment-and-classification-of-protocol-deviations
#14
Ravindra Bhaskar Ghooi, Neelambari Bhosale, Reena Wadhwani, Pathik Divate, Uma Divate
INTRODUCTION: Deviations from the approved trial protocol are common during clinical trials. They have been conventionally classified as deviations or violations, depending on their impact on the trial. METHODS: A new method has been proposed by which deviations are classified in five grades from 1 to 5. A deviation of Grade 1 has no impact on the subjects' well-being or on the quality of data. At the maximum, a deviation Grade 5 leads to the death of the subject...
July 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27453829/assessment-of-adherence-to-the-statistical-components-of-consolidated-standards-of-reporting-trials-statement-for-quality-of-reports-on-randomized-controlled-trials-from-five-pharmacology-journals
#15
Sachin Satpute, Manthan Mehta, Sandeep Bhete, Dnyneshwar Kurle
BACKGROUND: The Consolidated Standards of Reporting Trials (CONSORT) statement is a device to standardize reporting and improve the quality of controlled trials. However, little attention is paid to the statistical components in the CONSORT checklist. The present study evaluates the randomized controlled trials [RCTs] published in five high impact pharmacology journals with respect to its statistical methods. METHODS: Randomized Controlled Trials [RCTs] published in the years 2013 & 2014 in five pharmacology journals with high impact factor, The Journal of Clinical Pharmacology (JCP), British Journal of Clinical Pharmacology (BJCP), European Journal of Clinical Pharmacology (EJCP), Journal of Pharmacology & Pharmacotherapeutics (JPP) and Indian Journal of Pharmacology (IJP) were assessed for adherence to the statistical components of CONSORT statement...
July 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27453828/comparison-of-good-clinical-practice-compliance-and-readability-ease-of-the-informed-consents-between-observational-and-interventional-clinical-studies-in-the-emirates
#16
Satish Chandrasekhar Nair, Halah Ibrahim, Omar Sherif Askar
BACKGROUND: Expansion of clinical trials activity into emerging regions has raised concerns regarding participant rights and research ethics. Increasing numbers of observational studies are now conducted in developing economies, including the United Arab Emirates. MATERIALS AND METHODS: This study compares the content of information provided, Good Clinical Practice (GCP) guideline compliance, and readability of informed consent forms (ICFs) for observational compared to interventional studies...
July 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27453827/emerging-role-of-bioinformatics-tools-and-software-in-evolution-of-clinical-research
#17
REVIEW
Supreet Kaur Gill, Ajay Francis Christopher, Vikas Gupta, Parveen Bansal
Clinical research is making toiling efforts for promotion and wellbeing of the health status of the people. There is a rapid increase in number and severity of diseases like cancer, hepatitis, HIV etc, resulting in high morbidity and mortality. Clinical research involves drug discovery and development whereas clinical trials are performed to establish safety and efficacy of drugs. Drug discovery is a long process starting with the target identification, validation and lead optimization. This is followed by the preclinical trials, intensive clinical trials and eventually post marketing vigilance for drug safety...
July 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27453826/reporting-of-adverse-events-for-marketed-drugs-need-for-strengthening-safety-database
#18
REVIEW
Aditi Anand Apte
Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported. This article discusses the need to strengthen national safety database by promoting and mandating reporting of adverse events by all the stakeholders...
July 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27453825/how-informed-are-our-subjects
#19
Ravindra B Ghooi
No abstract text is available yet for this article.
July 2016: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/27141478/common-pitfalls-in-statistical-analysis-the-perils-of-multiple-testing
#20
Priya Ranganathan, C S Pramesh, Marc Buyse
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.
April 2016: Perspectives in Clinical Research
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