scholarly journals Why New Drugs, Treatments, and Medical Devices Still Needs to be Tested Clinically Before Making it Available in the Market? A Systematic Review

2019 ◽  
Vol 3 (1) ◽  
pp. 1-5 ◽  
Author(s):  
Naiya Patel
Keyword(s):  
Clinical Trials ◽  
Evidence Based Medicine ◽  
Target Population ◽  
New Drugs ◽  
Health Study ◽  
Evidence Based ◽  
Research Papers ◽  
New Drug ◽  
Public Health Study ◽  
Based Medicine

Objective Testing a new drug, treatment, and medical device clinically is critically important before prescribing it to patient. Not determining the drug’s safety and efficacy through clinical trials might impose life threatening outcomes on its consumers. The research paper describes the critical factors associated for testing any new drugs clinically, as limited research is performed in this field of public health. Study Design A qualitative systematic literature review was performed by mining relevant original peer reviewed research papers as well as some online resources like MedlinePlus due to limited availability of studies on such critical topic. Methods The databases used were Web of Sciences core collection, PubMed, Google scholar. The keywords used to search research papers were “clinical trials”, “testing new drugs”, “history of testing drugs”, “evidence-based medicine”. Conclusion Drugs which are prescribed to critical target population like pregnant women and children should be more often clinically tested if possible as majority of them are available in the market without Food and Drug Administration (FDA) approval. The abusive potential of any new drug could end up taking lives of innocent individuals. More evidence-based medicine can help translate research results on a heterogeneous population efficiently.

scholarly journals Clinical Trials: What, Where, When?

2018 ◽  
Vol 73 (5) ◽  
pp. 314-320
Author(s):  
Olga S. Kobyakova ◽  
Ivan A. Deev ◽  
Evgeny S. Kulikov ◽  
Roman I. Shtykh ◽  
Igor D. Pimenov ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Evidence Based Medicine ◽  
Randomized Clinical Trials ◽  
Professional Community ◽  
New Drugs ◽  
Evidence Based ◽  
Literature Analysis ◽  
Complete Knowledge ◽  
Reliable Knowledge ◽  
Based Medicine

Currently randomized clinical trials (RCTs) are a key stage in the development of new drugs. Despite the huge scale of the CT market, general awareness of the issue remains low and the society has formed a number of stereotypes and misconceptions about CTs. The presented review of Russian and foreign studies provides the information on the level of general awareness of clinical research in different countries, as well as among patients and practitioners. The conducted literature analysis demonstrates that awareness of clinical trials remains low both in society at large and among patients or in the professional community of practitioners. According to foreign studies, only 20–30% of respondents have heard anything about medical research while a relatively small percentage of respondents have more complete knowledge of RCTs. Among practitioners, only one in five is sufficiently informed about CTs while, according to different data, only about half fully realize what evidence-based medicine is and understand the importance of CTs as a source of reliable knowledge in everyday practice.

scholarly journals Bias against Vitamin C in Mainstream Medicine: Examples from Trials of Vitamin C for Infections

Life ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. 62
Author(s):  
Harri Hemilä ◽  
Elizabeth Chalker
Keyword(s):  
Clinical Trials ◽  
Vitamin C ◽  
Common Cold ◽  
Evidence Based Medicine ◽  
Evidence Based ◽  
The Third ◽  
Nutritional Recommendations ◽  
Mainstream Medicine ◽  
The Common ◽  
Based Medicine

Evidence has shown unambiguously that, in certain contexts, vitamin C is effective against the common cold. However, in mainstream medicine, the views on vitamin C and infections have been determined by eminence-based medicine rather than evidence-based medicine. The rejection of the demonstrated benefits of vitamin C is largely explained by three papers published in 1975—two published in JAMA and one in the American Journal of Medicine—all of which have been standard citations in textbooks of medicine and nutrition and in nutritional recommendations. Two of the papers were authored by Thomas Chalmers, an influential expert in clinical trials, and the third was authored by Paul Meier, a famous medical statistician. In this paper, we summarize several flaws in the three papers. In addition, we describe problems with two recent randomized trial reports published in JAMA which were presented in a way that misled readers. We also discuss shortcomings in three recent JAMA editorials on vitamin C. While most of our examples are from JAMA, it is not the only journal with apparent bias against vitamin C, but it illustrates the general views in mainstream medicine. We also consider potential explanations for the widespread bias against vitamin C.

The future of clinical trials

2010 ◽  
pp. 45-47
Author(s):  
Perry Nisen ◽  
Patrick Vallance
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Alternative Medicine ◽  
20Th Century ◽  
Evidence Based Medicine ◽  
Evidence Based ◽  
Scientific Evaluation ◽  
New Treatments ◽  
Based Medicine ◽  
Short Section

Clinical trials are the bedrock of evidence-based medicine. Introduced in the mid 20th century, they heralded a move away from opinion and anecdote to a more scientific evaluation of new treatments. Indeed, it could be argued that it is the clinical trial and the application of scientific method to determine which treatments work that distinguishes ‘medicine’ from ‘alternative medicine’. The aim of this short section is to outline the way in which clinical trials are likely to evolve over the next few years....

An overview of study designs

2020 ◽  
Vol 81 (5) ◽  
pp. 1-6
Author(s):  
Julian Aquilina ◽  
Joana B Neves ◽  
Maxine GB Tran
Keyword(s):  
Clinical Trials ◽  
Study Design ◽  
Evidence Based Medicine ◽  
Evidence Based ◽  
Advantages And Disadvantages ◽  
Valid Evidence ◽  
Study Designs ◽  
Based Medicine

The numbers of clinical trials have increased exponentially over the last decade, amplifying the pressure to select an appropriate study design to obtain reliable and valid evidence. The ability to find, critically appraise and use evidence to develop new interventions is fundamental to evidence-based medicine. Different study designs have their own advantages and disadvantages, and provide different evidentiary value. This article provides an overview of clinical trials, illustrating that, ultimately, the study design chosen needs to meet experimental and funding limitations, while minimising error.

Evidence-Based Medicine and Headache Patient Management by General Practitioners in Italy

Cephalalgia ◽  
2005 ◽  
Vol 25 (10) ◽  
pp. 767-775 ◽  
Author(s):  
A Bianco ◽  
MM Parente ◽  
E De Caro ◽  
R Iannacchero ◽  
U Cannistrà ◽  
...  
Keyword(s):  
Clinical Trials ◽  
General Practitioners ◽  
Evidence Based Medicine ◽  
Clinical Effectiveness ◽  
Clinical Approach ◽  
Evidence Based ◽  
Sources Of Information ◽  
Headache Patient ◽  
Practice Characteristics ◽  
Based Medicine

The study explores the awareness of technical terms used in evidence-based medicine (EBM) and manner of treating patients with migraine among a random sample of 500 general practitioners (GPs). A mailed questionnaire included questions on GPs' demographics and practice characteristics; awareness of EBM; sources of information about migraine and EBM; and patient's treatment behaviour. Only 27.2% of GPs agreed that clinical trials are needed to evaluate the efficacy of treatments and this awareness was higher in those who learned about migraine from scientific journals or continuing education courses and who attended courses on EBM. For two-thirds of GPs, disability is equivalent to illness diagnosis, and this behaviour was more prevalent in those who agreed that clinical trials are needed to evaluate the efficacy of preventive or curative treatments of migraine and that the clinical approach to migraine required an evaluation of clinical effectiveness, in those who treated a lower number of headache patients, who were older, and in those who did not use guidelines. The majority (93.1%) of GPs indicated that it is important to integrate clinical practice and the best available evidence, and this behaviour was significantly more frequent in those who agreed that the clinical approach to migraine required a clinical effectiveness evaluation, that clinical trials are needed to evaluate the efficacy of preventive or curative treatments of migraine, and in those who attended courses on EBM. Training and continuing educational programmes on EBM and guidelines on treatments of headache for GPs are strongly needed.

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