Corpus ID: 32917242

Clinical Research Methodology

@article{Gandhi2011ClinicalRM,
  title={Clinical Research Methodology},
  author={Purvi Gandhi},
  journal={Journal of Pharmaceutical Research},
  year={2011},
  volume={45}
}
  • P. Gandhi
  • Published 2011
  • Medicine
  • Journal of Pharmaceutical Research
Medical trials occupy a greater part of clinical trials and exceed in number over other types of clinical trials. Although clinical researches or studies other than those falling under the category of trial, lack the commercial aspect, they may contribute to the betterment of clinical practice and may constitute a base for large-scale commercial trials. Explanatory clinical studies are the most widely accepted and executed type of clinical researches/ trials. They explain not only the… Expand
Glossary for randomized clinical trials.
TLDR
The aim of the current paper is to present a comprehensive glossary of the terminology used in randomized clinical trials in order to assist authors when designing, executing and writing-up randomizedclinical trials. Expand
Protocol Development in Clinical Trials for Healthcare Management
TLDR
Protocol is a roadmap for team of healthcare professionals involved in investigation work and should explain the significance of research trial, location, detail procedure, methods, activities, time allotment, financial estimate and any other information required. Expand
India's Clinical Trial Regulatory Changes, Indian Researcher?s Awareness of Recently Changed Regulations, and the Impact of the New Drugs and Clinical Trial Rules: A Review
Medical companies consider India is above other countries worldwide as an alternative nation for clinical trials due to easily available sources and infrastructure. However, the developing IndianExpand
Comprehensive Survey of Clinical Trials Registration for Melanoma Immunotherapy in the ClinicalTrials.gov
TLDR
Currently, most of the registered clinical trials for melanoma immunotherapy were interventional open-label trials, and most immunotherapy research hotspots were in the FDA-regulated drug product, and a few trials reported available test results. Expand
Evidence Based Medicine- Hydrocephalus Guideline for Systemic Reviews, Meta-analysis and Evidence Based Medicine
TLDR
The optimum and proper management of hydrocephalus is the main goal for all neurosurgeons all over the world and the search for the best treatment for each and every type of hydrophalus is a necessity. Expand
A questionnaire based comparative study on dry lab versus wet lab among second year medical undergraduates in a tertiary care hospital of Bihar
TLDR
Although there is no substitution of conventional teaching methods, in this new era of information and technology CAL lab can be the saviour to students in making better understanding and enhancing the performance without help of experimental animals. Expand
Research methodology workshops evaluation using the Kirkpatrick’s model: Translating theory into practice
TLDR
The results from participants' performance revealed an overall positive feedback and 79% of participant reported transfer of training skills at their workplace and the course outcomes achievement and suggestions given for improvements offer insight into the program which were encouraging and very useful. Expand

References

SHOWING 1-10 OF 14 REFERENCES
Clinical Research in India: An Update
TLDR
Significant efforts are warranted to educate the professionals about pharmacogenomic and pharmacovigilance studies so as to ensure safety of the participants and minimize the possibilities of trial failure, says the present communication. Expand
New Developments in Medical Clinical Trials
TLDR
This paper reviews several new developments and long-standing good practices for conducting clinical trials, including the current trend of the replacement of placebo-controlled trials by active controlled non-inferiority trials, the increasing use of Independent Data Monitoring Committees, the prominence of analysis on Intention-to-Treat samples, and the importance of imputation of missing data. Expand
Biostatistics in clinical trials: Part 2. Determining sample sizes for clinical trials.
TLDR
The appropriate sample size for a clinical trial depends on the objectives of the trial and the type of endpoint that is to be the primary focus of analysis, and tables of sample sizes for a variety of situations are presented. Expand
Biostatistics in Clinical Trials
TLDR
Adaptive and Dynamic Methods of Treatment Assignment, Statistical Review for Medical Journals, Guidelines for Authors, and Society for Clinical Trials. Expand
Dose translation from animal to human studies revisited
TLDR
BSA correlates well across several mammalian species with several parameters of biology, including oxygen utilization, caloric expenditure, basal metabolism, blood volume, circulating plasma proteins, and renal function, and is advocated as a factor when converting a dose for translation from animals to humans. Expand
Quality of life is a primary end-point in clinical settings.
TLDR
There is no gold standard way to measure QOL and the existence of a huge number of measures and related QOL concepts makes it difficult to discuss QOL, so it is important to keep looking for the good construct and the good measure. Expand
Pharmaceutical statistics: Practical and clinical applications
Basic definitions and concepts data graphics introduction to probability - the binomial and normal probability distributions choosing samples statistical inference - estimation and hypothesis testingExpand
Evaluation of Angiotensin II Receptor Blockers for 24‐Hour Blood Pressure Control: Meta‐Analysis of a Clinical Database
TLDR
A meta‐analysis of five large, multicenter trials in which ambulatory blood pressure monitoring was used to compare the antihypertensive effects of three angiotensin II receptor blockers revealed that telmisartan 80 mg was significantly more effective than losartan 50 mg and valsartan80 mg for reducing 24‐hour mean blood pressure. Expand
Introduction to Statistical Quality Control
TLDR
This book discusses the development of process quality, design and improvement in the modern business environment, and methods and philosophy of Statistical Process Control. Expand
...
1
2
...