Clinical trials

2015 ◽  
Author(s):  
Richard Haynes ◽  
Martin J. Landray ◽  
William G. Herrington ◽  
Colin Baigent
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Large Scale ◽  
Randomized Trials ◽  
Evidence Base ◽  
Relevant Study ◽  
Large Numbers ◽  
Trial Outcomes ◽  
Clinical Questions ◽  
The Many

Randomized trials are the best method for identifying and quantifying the benefits and risks of interventions in clinical practice. Nephrology lags behind most specialties in medicine in its evidence base. Many commonly used therapies are untested and may be ineffective or even cause harm. For trials to provide reliable answers to important clinical questions they must first avoid two sources of error. Firstly, systematic error (or bias) can only be removed by proper randomization. Secondly, random error (the play of chance) can only be removed by the randomization of large numbers of patients (and therefore the accrual of large numbers of trial outcomes). Following successful large-scale randomization, it is critical that patients’ compliance with their allocated treatment is maintained, relevant study outcomes are systematically ascertained, and appropriate statistical analyses are performed. There is an urgent need to conduct such trials to address the many important clinical questions in nephrology.

scholarly journals Review of properties and mechanisms of action of hepatoprotective drugs

2020 ◽  
pp. 36-44
Author(s):  
Е.В. Кардаш ◽  
Е.М. Григорьева ◽  
А.Г. Емельянова ◽  
С.А. Тарасов
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Side Effects ◽  
Randomized Clinical Trials ◽  
Evidence Base ◽  
Mechanisms Of Action ◽  
New Drugs ◽  
Simultaneous Administration ◽  
Essential Phospholipids ◽  
Meta Analyses

В медицинской практике достаточно часто возникает необходимость в одновременном приеме нескольких лекарственных средств. Иногда это оказывается невозможным в силу наличия у препаратов гепатотоксических свойств, поэтому актуальными задачами фармакологии являются как поиск и разработка новых препаратов, так и оптимизация уже существующих с целью уменьшения побочных эффектов при их приеме. В настоящем обзоре были проанализированы данные о фармакологических препаратах класса гепатопротекторов, разобраны механизмы их действия и потенциал поиска новых препаратов. В заключение отмечено, что в настоящее время в клинической практике наибольшей популярностью пользуются препараты, содержащие эссенциальные фосфолипиды и препараты, улучшающие рециркуляцию и выведение желчных кислот. Существуют теоретические обоснования механизмов действия этих препаратов и перспектива накопления доказательной базы для них в виде рандомизированных клинических исследований и мета-анализов. Medical practice quite often requires simultaneous administration of several drugs. Sometimes it is impossible due to their hepatotoxicity; therefore, urgent tasks of pharmacology include searching for and developing new drugs as well as optimizing already existing products in order to reduce side effects during their administration. This review focused on pharmacological drugs of the hepatoprotector class and their mechanisms of action and evaluated the prospects of searching for new medicines. In conclusion, drugs containing essential phospholipids and those improving recirculation and removal of bile acids are currently the most popular agents in clinical practice. Mechanisms of action of these drugs are theoretically justified and there is a prospect for building an evidence base for them by randomized clinical trials and meta-analyses.

scholarly journals Fast and Comprehensive N- and O-glycoproteomics analysis with MSFragger-Glyco

2020 ◽  
Author(s):  
Daniel A. Polasky ◽  
Fengchao Yu ◽  
Guo Ci Teo ◽  
Alexey I. Nesvizhskii
Keyword(s):  
Large Scale ◽  
Fold Increase ◽  
Search Strategies ◽  
Spectrometric Analysis ◽  
Computational Tool ◽  
Post Translational Modification ◽  
Fast Speed ◽  
Large Numbers ◽  
Highly Sensitive ◽  
The Many

AbstractGlycosylation is a ubiquitous and heterogeneous post-translational modification (PTM) used to accomplish a wide variety of critical cellular tasks. Recent advances in methods for enrichment and mass spectrometric analysis of intact glycopeptides have produced large-scale, high-quality glycoproteomics datasets, but interpreting this data remains challenging. In addition to being large, complex, and heterogeneous, glycans undergo fragmentation during vibrational activation, making common PTM search strategies ineffective for their identification. We present a computational tool called MSFragger-Glyco for fast and highly sensitive identification of N- and O-linked glycopeptides using open and glycan mass offset search strategies. Reanalysis of recently published N-glycoproteomics data resulted in annotation of 83% more glycopeptide-spectrum matches (glycoPSMs) than in previous results, which translated to substantial increases in the numbers of glycoproteins and glycosites that could be identified. In published O-glycoproteomics data, our method more than doubled the number of glycoPSMs annotated when searching the same peptides as the original search and resulted in up to a 6-fold increase when expanding searches to include large numbers of possible glycan compositions and other modifications. Expanded searches revealed trends in glycan composition and crosstalk with phosphorylation that remained hidden to the original search. With greatly improved spectral annotation, coupled with the fast speed of fragment ion index-based scoring, MSFragger-Glyco makes it possible to comprehensively interrogate glycoproteomics data and illuminate the many roles of glycosylation.

scholarly journals Novel Clinical Trial Designs to Improve the Efficiency of Research

2020 ◽  
Vol 132 (1) ◽  
pp. 69-81 ◽  
Author(s):  
Daniel I. Sessler ◽  
Paul S. Myles
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Real Time ◽  
Randomized Trials ◽  
Clinical Evidence ◽  
Adaptive Designs ◽  
Large Numbers ◽  
Clinical Trial Designs ◽  
Study Sites ◽  
Trial Efficiency

Abstract SUMMARY Large randomized trials provide the highest level of clinical evidence. However, enrolling large numbers of randomized patients across numerous study sites is expensive and often takes years. There will never be enough conventional clinical trials to address the important questions in medicine. Efficient alternatives to conventional randomized trials that preserve protections against bias and confounding are thus of considerable interest. A common feature of novel trial designs is that they are pragmatic and facilitate enrollment of large numbers of patients at modest cost. This article presents trial designs including cluster designs, real-time automated enrollment, and practitioner-preference approaches. Then various adaptive designs that improve trial efficiency are presented. And finally, the article discusses the advantages of embedding randomized trials within registries.

Trials

2021 ◽  
pp. 177-188
Author(s):  
Edward Shorter
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Fundamental Problem ◽  
Endogenous Depression ◽  
Evidence Base ◽  
Drug Trials ◽  
Depression Treatments ◽  
Real Patients

In the years after 1980, drug trials departed increasingly from the concept of treating real patients. Clinical trials accompanied psychopharmacology as a basic means of gathering evidence in the field, but they also served as the premier means of evasion and distortion used fraudulently and covertly to corrupt the evidence base of psychopharmacology. The fundamental problem in running clinical trials of depression treatments was that the “patients” were considered heterogeneous or “fantasy patients” who really had nothing. Leo Hollister recommended that depression trials be confined to patients with serious or “endogenous” depression, who were the minority of patients encountered in clinical practice.

International and National Problems in Fisheries Seabird By-Catch

2008 ◽  
Vol 3 (3) ◽  
pp. 187-195 ◽  
Author(s):  
Haruo Ogi ◽  
Keyword(s):  
Large Scale ◽  
Conservation Areas ◽  
The North ◽  
Common Murre ◽  
Large Numbers ◽  
By Catch ◽  
Fishing Fleets ◽  
Northern Territories ◽  
The Many ◽  
High Seas

Large-scale international fisheries have seen many developments, including the adoption of 200-mile fishing limits by many countries, including Japan, between 1976 and 1977. On the North Pacific high seas, the use of neon flying squid and large-mesh driftnets is expanding rapidly. The many kinds and large numbers of nontargeted species caught in such driftnets, however, influenced world public opinion and the United Nations to prohibit driftnet fishing on the high seas in 1991. The investigation on the consequences of such driftnets have been often failed to be conducted in Japan, because Japan’s fisheries have been downsized. Japan’s fishing industry has not addressed this problem appropriately, even though the authorities have recommended that fishing fleets minimize by-catch. Japan has no legislation designating sea surface conservation for sealife, and fisheries by-catch have dramatically reduced the number of breeding seabirds in isolated habitats. The Japanese murrelet (Synthliboramphus wumizusume) of Miyazaki Prefecture and the common murre (Uria aalge) and the tufted puffin (Lunda cirrhata) of Hokkaido face a serious situation. The number of the spectacled guillemot (Cepphus carbo) living along Tohoku-Hokkaido coast has rapidly decreased due to by-catch fishing. Russia has legislation designating breeding places for seabirds and animals and designating surroundings as conservation areas. The Northern Territory adjoining Hokkaido thus has extremely diverse sea species. Japan has no corresponding legislation to succeed the Russian conservation legislation if Russia should return the Northern Territories to Japan.

scholarly journals Recent findings on perinatal mesenchymal stem cells – their possible application in current advanced medicine

2021 ◽  
Vol 9 (2) ◽  
pp. 48-55
Author(s):  
Rafał Sibiak ◽  
Katarzyna Stefańska ◽  
Kornel Ratajczak ◽  
Dorota Bukowska ◽  
Paweł Antosik ◽  
...  
Keyword(s):  
Stem Cells ◽  
Clinical Trials ◽  
Mesenchymal Stem Cells ◽  
Large Scale ◽  
Randomized Trials ◽  
Experimental Treatment ◽  
Degenerative Diseases ◽  
Cesarean Sections ◽  
Vaginal Deliveries

Abstract The mature human placenta and umbilical cord are rich sources of perinatal mesenchymal stem cells (MSCs). Both cell populations have similar characteristics and cellular properties. Each population can differentiate into multiple mesenchymal subpopulations and retain their self-renewal capacities. Perinatal stem cells can be isolated from tissues obtained from the planned cesarean sections and vaginal deliveries. Their isolation is relatively easy, making them readily available for implementation in various in vitro studies and clinical trials. Their differentiation abilities could be used in advanced regenerative medicine protocols to form new bone, cartilage, or tendons. Moreover, their unique anti-inflammatory and immunomodulatory properties have been implemented in the experimental treatment of multiple autoimmune and degenerative diseases. Numerous phase I/II clinical trials confirmed the safety of perinatal MSCs injections and infusions, albeit the efficacy of those cellular therapies should be investigated in the subsequent large-scale randomized trials. Running title: Clinical applications of the perinatal mesenchymal stem cells

scholarly journals Evidence-based approaches to comparing the effectiveness of modern cardiology interventions: trends, bias and prospects

2020 ◽  
Vol 25 (8) ◽  
pp. 4037
Author(s):  
S. R. Gilyarevsky ◽  
Yu. N. Belenkov
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Drug Use ◽  
Propensity Score ◽  
Observational Studies ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Evidence Based ◽  
Improved Methods

The article discusses the limitations of the evidence from observational studies. Modern approaches to reducing bias in observational studies are discussed in detail, in particular, propensity score matching, which has become popular in recent years. The main differences between randomized and observational studies are discussed. Arguments against the observational studies and improved methods of analysis to compare the treatments’ effectiveness in clinical practice are presented. The role of observational studies as a source of evidence is discussed. The article points out the validity of performing large-scale prospective observational studies to assess the effects of postmarketing drug use in clinical practice, as well as to obtain data on drug use in patients that differ from those in randomized clinical trials.

scholarly journals Subclinical Hypothyroidism – What is Responsible for its Association with Cardiovascular Disease?

2016 ◽  
Vol 12 (2) ◽  
pp. 96
Author(s):  
Alexander Sorisky ◽  
Keyword(s):  
Cardiovascular Disease ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Subclinical Hypothyroidism ◽  
Large Scale ◽  
Common Condition ◽  
Population Demographics ◽  
Epidemiological Analysis ◽  
Increased Risk ◽  
Prevalence Estimates

Subclinical hypothyroidism (SH) is a common condition, with prevalence estimates ranging from 4–20%, depending on the population demographics. Although epidemiological analysis associates it with an increased risk of cardiovascular disease, clinical practice guidelines express uncertainty about whether to monitor or to treat. As we await large-scale, well-designed randomised clinical trials regarding treatment of SH, a review of pathophysiological considerations may be informative to better understand this disorder.

Meta-Analysis: Methodology, Utility, and Limitations

1998 ◽  
Vol 11 (4) ◽  
pp. 239-250 ◽  
Author(s):  
Michael A. Mancano ◽  
Michael F. Bullano
Keyword(s):  
Meta Analysis ◽  
Clinical Trial Data ◽  
Data Sets ◽  
Analysis Methodology ◽  
Large Numbers ◽  
Methodological Problems ◽  
Clinical Questions ◽  
The Many ◽  
Many Sources ◽  
Meta Analyses

Meta-analyses are statistical methods to evaluate large numbers of clinical trial data sets to answer specific clinical questions. Meta-analyses can be performed when large clinical trials are not available or prior to their availability. It is essential for pharmacists to effectively evaluate potential methodological problems and be aware of the current controversies surrounding meta-analysis. This article will focus on the components of a properly performed meta-analysis and the many sources of bias inherent in a literature review of this magnitude. A suggested reading list of in-depth references concerning the many aspects of meta-analysis is provided for the interested reader.

scholarly journals Experiences with the Execution of Intercultural, Intercontinental Trials - Part I

2013 ◽  
Vol 40 (3) ◽  
pp. 324-329 ◽  
Author(s):  
H. J. M. Barnett
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Effective Means ◽  
Important Research ◽  
Adequate Funding ◽  
Research Questions ◽  
Clinical Questions

Large scale, international clinical trials are formidable challenges, but they are the most effective means of answering important clinical questions in a definitive, generalizable manner. They require adequate funding and must be rigorously conducted. Much can be gleaned from such studies, which address the important research questions and provide answers to related questions. Such trials are enormously rewarding and are worth the expense and effort.

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