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Perspectives in Clinical Research

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https://www.readbyqxmd.com/read/28447023/virtue-ethics-of-clinical-research
#1
María PérezñPinar, Luis Ayerbe
No abstract text is available yet for this article.
April 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28447022/common-pitfalls-in-statistical-analysis-linear-regression-analysis
#2
Rakesh Aggarwal, Priya Ranganathan
In a previous article in this series, we explained correlation analysis which describes the strength of relationship between two continuous variables. In this article, we deal with linear regression analysis which predicts the value of one continuous variable from another. We also discuss the assumptions and pitfalls associated with this analysis.
April 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28447021/clinical-trials-in-dentistry-in-india-analysis-from-trial-registry
#3
S Gowri, Sridharan Kannan
INTRODUCTION: Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. METHODOLOGY: All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www...
April 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28447020/impact-of-educational-intervention-on-knowledge-attitude-and-awareness-of-good-clinical-practice-among-health-care-providers
#4
Divya Goel, Rani Walia, Poonam Sharma, Harmanjeet Kaur, Pallak Agnihotri
BACKGROUND: Clinical trials play an important role in the generation of evidence-based data in health care practices. To ensure the credibility of data and the safety and well-being of the patients Good clinical practice (GCP) guidelines play an important role. At present, we have little knowledge about awareness of GCP guidelines among health care providers in India. AIM: To assess the level of awareness, and perception of the health care providers toward GCP and subsequent change in these after a dayer training session on GCP guidelines...
April 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28447019/a-cross-sectional-study-need-of-equal-respect-for-all-professionals-in-the-institutional-ethics-committees-composition
#5
Ramandeep Kaur, Ajay Francis Christopher, Vikas Gupta, Parveen Bansal
BACKGROUND: The composition of the Institutional Ethics Committee (IEC) with an equal respect plays a major role in evaluating research proposals to ensure the safety of the subjects and ethical quality of research project. It is mandatory that all research projects with an involvement of human subjects should be approved by the IEC before commencement. AIM: To find out the equality of respect to members of IEC irrespective of nature of their profession. MATERIALS AND METHODS: Methods include a cross-sectional study, the general information and member composition, multidisciplinary nature, independent performance, competence, decision capability, professionally biased of IECs in health research institutions of Punjab, India...
April 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28447018/predictors-of-over-the-counter-medication-a-cross-sectional-indian-study
#6
Abinash Panda, Supriya Pradhan, Gurukrushna Mohapatro, Jaya Singh Kshatri
CONTEXT: The determinants of over-the-counter (OTC) medication need to be understood to design adequate drug information policies. AIM: To determine the prevalence and predictors of OTC medication among the adult population of Berhampur town in Odisha, India. SETTINGS AND DESIGN: It was a prospective, cross-sectional, observational study carried out in the private retail pharmacy on a convenience sample of 880 adults over a period of 6 months at Berhampur, Odisha, India...
April 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28447017/in-sickness-and-in-health-clinical-research-and-social-media
#7
REVIEW
Saswata Ray
In this "digital age," the model of healthcare is changing rapidly, primarily in the area of communication that is happening among the major stakeholders each minute. Patients, being the central point of the importance of all the work and development, are more empowered than ever with information from various sources, among which social media is leading from the front. This article reviews how social media engages healthcare service providers, service seekers, and regulatory authorities. If the gaps in the current regulations are filled, better healthcare outputs can be triggered...
April 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28447016/deriving-meaningful-insights-from-clinical-trial-and-postmarketing-safety-data-perspectives-from-india
#8
REVIEW
Anand Harugeri, Vineet Shastri, Chanakya Patel
Today, drug safety data collection in India is both manual and electronic with reporting of potential overlapping and duplicate data, which is likely incomplete for further review and analysis. Furthermore, standardized data collection and timelines are not aligned with international standards. Complete coverage of safety data from all sources throughout the life of the drug cannot be ensured. There is no requirement to submit periodic safety data in clinical trials to regulatory authority. There is clearly a lack of emphasis on deriving meaningful safety data insights for ensuring patient safety...
April 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28447015/data-sharing-a-viable-resource-for-future
#9
REVIEW
Kritarth Naman M Singh, Yashashri C Shetty
Clinical trials and research studies are being conducted worldwide at a rampant pace leading to generation of large amount of data. However, to reap the benefits of the data generated it is important that this data is shared with the general public without which it can be deemed useless. Despite its importance being known to us, data sharing does not come without its share of problems and it is not as easy to execute as it sounds on-paper. Over the past few years, multiple coveted organizations around the world involved in research activities have come up with their respective guidelines and initiatives to make sure the sharing of research data is smooth and ethical...
April 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28447014/narrative-writing-effective-ways-and-best-practices
#10
REVIEW
Samir D Ledade, Shishir N Jain, Ankit A Darji, Vinodkumar H Gupta
A narrative is a brief summary of specific events experienced by patients, during the course of a clinical trial. Narrative writing involves multiple activities such as generation of patient profiles, review of data sources, and identification of events for which narratives are required. A sponsor outsources narrative writing activities to leverage the expertise of service providers which in turn requires effective management of resources, cost, time, quality, and overall project management. Narratives are included as an appendix to the clinical study report and are submitted to the regulatory authorities as a part of dossier...
April 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28447013/is-there-a-need-for-investigator-initiated-research
#11
EDITORIAL
Viraj Ramesh Suvarna
No abstract text is available yet for this article.
April 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28194338/development-of-medical-writing-in-india-past-present-and-future
#12
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
#13
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
#14
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
#15
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
#16
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. THE PAST: The requirement for an EC to oversee clinical research was first made in the ICMR Policy Statement for Ethics published in 1980 and then again in the Schedule Y (1988)...
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
#17
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
#18
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
#19
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
#20
EDITORIAL
Arun Bhatt
No abstract text is available yet for this article.
January 2017: Perspectives in Clinical Research
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