alexa Regional Factors Impairing Multicentral Clinical Trial Results
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
Open Access

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Share This Page

Additional Info

Loading
Loading Please wait..
 

4th International Conference on Pharmaceutical Regulatory Affairs
September 08-10, 2014 DoubleTree by Hilton Hotel Raleigh-Brownstone-University, USA

Vladimir Popov
Accepted Abstracts: Pharmaceut Reg Affairs
DOI: 10.4172/2167-7689.S1.016
Abstract
The number of international multicentral clinical trials involving the range of investigational sites located in various regions throughout the world, including the Russian Federation, permanently grows. Data shows that clinical trials findings could vary from region to region regardless of whether the sample had been homogeneous or not. First of all statistic analysis of multiregional multicentral clinical trials often requires stratification, separate data processing or significant increase of sample size. Secondly, while planning a multicentral clinical trial one should take into consideration special regional factors (logistic and clinical, exterior and interior), which could impair study results. The main clinical factors that should be taken into account when working out study design are diagnostics and treatment differences and pharmacogenetic variance of participating regions. Some examples of multiregional clinical trials confirming the phenomenon include: PLATO, EVEREST, PURSUIT, BEST, CIBIC-II, COPERNICUS, MERIT-HF, and HERO. Recent observations present the following rough geographical division into regions that are likely to differ in world-wide clinical studies results: North America, South America, Western Europe, and Eastern Europe. However even countries-neighbors, which are located nearby and have similar conditions of clinical trials conduction ex facte, differ in some features that could affect final results of the study. Besides complications in international study results analyzing, the problem could be urgent in case of transmitting the foreign local clinical data to other regions and assessing the acceptability.
Biography
Vladimir Popov, MD, PhD, Dr. MedSc is the Head of Clinical Pharmacology Department (?Scientific Medical Center?, JSC ?Russian Railways?), the leading researcher of Cardiology Department (Sechenov 1st Moscow State Medical University). He has published more than 140 papers, serves as an editorial board member of ?Drug Development and Registration? journal (Russia) and is a member of Cardiovascular Pharmacology and Drug Therapy working group of European Society of Cardiology, Russian Society of Pharmacoeconomics and Outcome Research, Society of Specialists in Evidence-Based Medicine (Russia), a faculty of Cardiovascular Clinical Trials Forum (France), a governor of International Society of Cardiovascular Pharmacotherapy, and a scientific expert of Romualdo Del Bianco Foundation (Italy).
image PDF   |   image HTML
 

Relevant Topics

Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri, Food, Aqua and Veterinary Science Journals

Dr. Krish

[email protected]

1-702-714-7001 Extn: 9040

Clinical and Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemical Engineering and Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001 Extn: 9040

Earth & Environmental Sciences

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

General Science and Health care Journals

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics and Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001 Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Informatics Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Material Sciences Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Mathematics and Physics Journals

Jim Willison

[email protected]

1-702-714-7001 Extn: 9042

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001 Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

John Behannon

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001 Extn: 9042

 
© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
adwords