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Perspectives in Clinical Research

Chetna Desai
No abstract text is available yet for this article.
April 2018: Perspectives in Clinical Research
Saurav Basu
No abstract text is available yet for this article.
April 2018: Perspectives in Clinical Research
Indu Nambiar
One of the reasons that a research molecule undergoes through different phases of clinical trials is to establish the safety and efficacy of the drug. To establish the safety profile of any drug, the most important aspect is to evaluate every adverse event (AE) that a clinical trial individual experiences. This detail is provided by any investigator or sponsor through the narratives that is prepared post the analysis of a serious AE. The purpose of this article is to emphasize the importance of these narratives...
April 2018: Perspectives in Clinical Research
Priya Ranganathan, Rakesh Aggarwal
Diagnostic tests are used to identify subjects with and without disease. In a previous article in this series, we examined some attributes of diagnostic tests - sensitivity, specificity, and predictive values. In this second article, we look at likelihood ratios, which are useful for the interpretation of diagnostic test results in everyday clinical practice.
April 2018: Perspectives in Clinical Research
Renju Ravi, Debdipta Bose, Nithya J Gogtay, Urmila M Thatte
Monitoring and audits are two distinct processes that ensure that the rights and safety of the participants are protected, and data integrity is maintained. The present narrative summates authors' experiences with monitoring and audits by sponsor along with challenges faced by the site. It also offers potential solutions for challenges faced during the process of monitoring and audits. It is important to remember that no monitoring or audit can ever substitute for a well-designed and articulated protocol. In addition, a determined approach by the investigator and his/her team to ensure that all aspects of the protocol are adhered to in totality will go a long way in assuring quality...
April 2018: Perspectives in Clinical Research
Sanish Davis
Continuing review of studies approved by the Ethics Committees (ECs) involves review of the progress of the study, annual reports, protocol deviations/violations, serious adverse event monitoring, and on-site monitoring. International and national regulations and guidelines for continuing review state that it is an opportunity for the EC to be assured that risks to subjects are minimized and is are reasonable in relation to anticipated benefits if any to the subjects and the knowledge it will generate. There are several barriers (e...
April 2018: Perspectives in Clinical Research
Manisha Shrivastava, Nehal Shah, Seema Navaid
Aim: In an era of evidence based medicine research is an essential part of medical profession whether clinical or academic. A research methodology workshop intends to help participants, those who are newer to research field or those who are already doing empirical research. The present study was conducted to assess the changes in knowledge of the participants of a research methodology workshop through a structured questionnaire. Methods: With administrative and ethical approval, a four day research methodology workshop was planned...
April 2018: Perspectives in Clinical Research
Jaya Prasad Tripathy, Pankaj Bahuguna, Shankar Prinja
Background: Poor prescription practices result in increased side effects, adverse drug reactions, and high cost of treatment. The present study was undertaken to describe the drug-prescribing patterns in two North Indian states through prescription auditing. Materials and Methods: The study was carried out in 80 public health facilities across 12 districts in two states of Haryana and Punjab (6 in each) covering all levels of care. The information from prescription slips was abstracted on a structured pro forma for all patients who visited the pharmacy of the health facility...
April 2018: Perspectives in Clinical Research
Saloni Amin, Samidh Shah, Mira Desai, Asha Shah, K M Maheriya
Objectives: To analyze clinical spectrum, seriousness, outcome, causality, severity and preventability of ADRs in geriatrics and pediatric patients. Materials and Methods: All ADRs reported in geriatrics (≥ 65 years) and pediatrics (≤ 12 years) indoor as well outdoor patients from January, 2010 to April, 2016 at ADR monitoring centre, Department of Pharmacology, B. J. Medical College and Civil Hospital were identified. A retrospective analysis was carried out for clinical presentation, causality (as per WHO-UMC scale and Naranjo's algorithm), severity (Hatwig and Seigel scale) and preventability (Schaumock and Thornton criteria)...
April 2018: Perspectives in Clinical Research
Padmaja A Marathe, Raakhi K Tripathi, Yashashri C Shetty, Sunil S Kuyare, Sandhya K Kamat, Urmila M Thatte
Objective: In view of dearth of information in national and international guidelines on payment practices in research, the present study was done to find out payments for participation allowed by 3 Ethics committees (ECs) and reasons for payment. Method: This was a retrospective observational study which analysed research proposals reviewed by 2 institutional and 1 non-institutional ECs over a period of 2 years. The permission of ECs was obtained and confidentiality of data was maintained...
April 2018: Perspectives in Clinical Research
Viraj Ramesh Suvarna
Real world evidence is important as it complements data from randomised controlled trials (RCTs). Both have limitations in design, interpretation, and extrapolatability. It is imperative one designs real world studies in the right way, else it can be misleading. An RCT is always considered higher in the evidence ladder and when there is discordance between a real world study and an RCT, it is the latter which is always considered pristine because of the way it is conducted, e.g., randomization, prospective, double-blind, etc...
April 2018: Perspectives in Clinical Research
Nithya Jaideep Gogtay
No abstract text is available yet for this article.
April 2018: Perspectives in Clinical Research
Natasha Das
No abstract text is available yet for this article.
January 2018: Perspectives in Clinical Research
Prasad Thota, Anusha Thota, Bikash Medhi, Shabir Sidhu, Pramod Kumar, V Kalai Selvan, Gyanendra Nath Singh
Background: The National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmacopoeia Commission works under the aegis of Ministry of Health and Family Welfare, Government of India. It promotes patient safety in India and also supports postmarketing surveillance programs. Currently, almost hundred thousand case reports are submitted to NCC-PvPI each year through its 250 ADR Monitoring Centers (AMCs) located across India, and India is the one of the top ten contributor countries under WHO-Uppsala Monitoring Centre since 2012 and start issuing drug safety alerts from March 2016...
January 2018: Perspectives in Clinical Research
Amita Bhave
This document provides updates in regulatory requirements regarding conduct of clinical trials in India.
January 2018: Perspectives in Clinical Research
Parvan A Shetty, Mitesh R Maurya, Brinal H Figer, Urmila M Thatte, Nithya J Gogtay
The quality of the written informed consent process is one of the most important aspects of clinical research, as it is the single tool that serves as a metric of autonomy. Several challenges have been identified with the informed consent process in developing countries the most important of which is the ability to assimilate and understand the information presented in the consent form. In India, a unique aspect of the informed consent process is the need for audio-video [AV] recording of the process for vulnerable populations and new chemical entities...
January 2018: Perspectives in Clinical Research
Priya Ranganathan, Rakesh Aggarwal
In this article in our series on common pitfalls in statistical analysis, we look at some of the attributes of diagnostic tests (i.e., tests which are used to determine whether an individual does or does not have disease). The next article in this series will focus on further issues related to diagnostic tests.
January 2018: Perspectives in Clinical Research
Arun Bhatt
The article discusses conflict of interest (COI) situations and how to manage COI in ethics committee (EC).
January 2018: Perspectives in Clinical Research
Mohit Joshi, Payal Bhardwaj
Data transparency has been an important aspect of medical research as it helps in enabling evidence-based decisions in medicine which leads to foster trust among the patients and research community alike. Currently, it is one of the key talking points owing to a number of initiatives taken by the pharmaceutical organizations, regulatory bodies, and the other decision enablers of the industry. Thanks to this, there are a number of ways by which a single piece of datum is available through multiple access points, namely, clinical trial disclosures (CTDs), clinical study reports (CSRs), plain language summaries, and scientific publications including abstracts, posters, and manuscripts, to name a few...
January 2018: Perspectives in Clinical Research
Shruti Singh, Prashant Kumar Singh
Background: Drug therapy today is remarkably safe and efficacious. Still, some drugs - particularly anticancer drugs - are fraught with numerous adverse drug reactions (ADRs), severely jeopardizing quality of life of cancer patients. Fortunately, most of these ADRs are preventable provided adequate prophylactic drugs are administered along with chemotherapy. Aims: The aim of this study is to assess the pattern and impact of cytoprotective prophylactic drugs on anticancer ADRs in patients receiving cancer chemotherapy...
January 2018: Perspectives in Clinical Research
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