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PUBLICATIONS

International Clinical Trials

ict
Winter 2011
   
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Regulatory & Business Practice
Mian Atif Saeed at Bristol-Myers Squibb argues that, although complex and lengthy, the drug development process has plenty of scope for changes to its usual framework that could help it become more streamlined, leaner and efficient.
 
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The huge cost to a project should it fail to meet compliance requirements compels imaging core labs to pay heed to 21 CFR Part 11. However, as Christian Teague at RadCore Labs, LLC and FDA Compliance Specialist David Nettleton point out, this can be seen as a positive step.
 
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Based on the principles of value management, Paul Naybour and Roger Joby at Parallel Project Training propose a collaborative approach to drug development feasibility studies, bringing the whole project team together to understand challenges and identify significant cost reduction strategies.
 
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TRIAL MANAGEMENT
Although randomised controlled trials provide more benefits than observational studies, the latter is becoming more common and therefore their statistical challenges need to be addressed. David J Pasta and Dave P Miller at ICON Clinical Research discuss two techniques that can be used to address group differences in these studies.  
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The cost of conducting early phase oncology studies has increased substantially over the last decade. However, the future holds the prospect of technological advances and trial management tools that can be used to reduce the expenses incurred, explains Kim Boericke at i3.  
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Michael Rosenberg of Health Decisions, Inc discusses how the combined use of adaptive operations, adaptive designs and supporting technologies can enable the pharma industry to break the efficiency barrier and rise above its own limitations.  
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Susan Suchdev of IRW Consulting considers the questions that investigators ask themselves during clinical research about quality, risk assessment, patient recruitment and site selection, and summarises seven critical steps for clinical study success.  
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Regional trials
Emerging regions feature increasingly in the list of top countries where clinical trials are being performed. Looking at Turkey, Karen I Politis Virk at Language Connections assesses the linguistic and regulatory challenges one should consider before outsourcing clinical research to this market.  
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Jörg Taubel, Keith Berelowitzand Ulrike Lorch at Richmond Pharmacology Limited make a case for conducting early phase clinical research in the UK over other European countries, and identify opportunities available for pharma companies and CROs alike.  
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eCLINICAL, DATA MANAGEMENT & STATISTICAL ANALYSIS
Interactive voice response systems have evolved beyond the telephone to provide a variety of solutions, from web-based randomisation to sophisticated drug supply monitoring. Charles Gasman at PharmaNet Development Group discusses the role these systems will play in future clinical trials.  
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As the search for patients leads to an increased globalisation of trials, Hugh P Levaux and Jaime Lau at UBC consider how interactive voice or web response systems can optimise the clinical trial process and ease the integration of global economies, such as Asia, into the market.  
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Valdo Arnera of PHT Corporation makes a case for automating the collection of patient reported outcome data as a way to achieve regulatory compliance and ensure patient safety, while also enabling eClinical trials that are less expensive, more accurate and safer than paper-based research.  
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THERAPEUTICS
DEXA technology has had an enormous impact on the measurement of bone densitometry in the last 50 years, and will continue to provide an essential resource for organisations conducting clinical trials, as shown by Annelee Spano Lander at CoreLab Partners and independent consultant Reta C Rupich.
 
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Paola Antonini and Michael F Murphy at Worldwide Clinical Trials examine trials in emergency departments, and assess the challenges that researchers face when conducting studies in this unpredictable workplace.
 
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Supply Chain & Manufacturing
Biological products are tricky to transport, but with the right packaging and logistics methods in place, problems can be overcome and savings achieved, as Rachel Griffiths at Biotec Services International explains.
 
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Peter Soelkner at Vetter Pharma International asks if it is sensible to partner in the early clinical development period, and if so, what the drug developer should look for in a potential contract manufacturer.
 
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Central Labs
Patrice Hugo at Clearstone Central Laboratories makes the case for centralised laboratories over decentralised,pointing to their flexibility and ability to combine all parties’needs, as well as identifying key trends that will affect these labs in the near future.
 
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Green initiatives in the laboratory are important not only to minimise any impact on the environment, but they also have implications in terms of safety and cost reduction, as highlighted by Tim Hynes at DaVita Clinical Research.
 
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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

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