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International Clinical Trials

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Spring 2015

   
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Editor’s Comment

Graham Hughes picks out some of the articles in this edition, including the trial support system behind cancer drug development and the vital first step of feasibility assessment.
 
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Regulatory & Business Practice
Trial Agreements

Under Contract


Resolving intellectual property issues when negotiating clinical trial agreements can be perplexing for US sponsors. Casting a legal eye over the subject, Blaine Templeman, Kristen Riemenschneider and Amy Ryan at Arnold & Porter LLP look to demystify some of the concerns.
 
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TRIAL MANAGEMENT
Feasibility Studies

Ahead of the Game


Helping a trial get up and running smoothly, a preliminary feasibility assessment is a key starting point before site qualification and study design takes shape. Bruce Smith at United BioSource Corporation outlines the reality check it provides and raises five critical questions sponsors should ask.
 
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ECG Management

Electric Charge

Late-stage drug failures and trial terminations due to cardio-toxic off-target effects have driven the popularity of early cardiac safety studies. But with managing electrocardiogram equipment an expensive part of these Phase 3 tests, Samiya Luthfia Khaleel of Beroe Inc explores some cost-effective measures.
 
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eCLINICAL
Patient Engagement

Get Personal

Pharma must learn to listen more if it is to make the most of patient experiences – and using mobile phones and tablets through a device-inclusive approach is now essential to secure true patient buy-in and better data capture, argues Exco InTouch's Tim Davis.
 
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Clinical Trial Supply & Packaging
Supply Chains

World in Motion

As trial logistics evolve, the industry is moving from the term 'cold chain' to the more inclusive phrase 'temperature-controlled transport'. Assessing current supply chain needs, World Courier's Sue Lee draws attention to preplanning and technology in ensuring customised and safe delivery of trial materials.
 
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Controlled Drugs

Out of Danger


The highly regulated field of controlled drugs – those liable to misuse or abuse – presents complex distribution demands at trial stage. PCI's Rachel Griffiths introduces the compliance landscape and emphasises the vital role of supply partners in keeping studies on schedule.
 
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MEDICAL IMAGING AND QT STUDIES
Cardiac Safety Studies

Heart of the Matter


The days could be numbered for the TQT approach to cardiac safety, now that high-precision QT analysis can be conducted in earlier dosing trials. Lorraine Rusch at Vince & Associates Clinical Research looks at how this can de-risk drug candidates by giving a more exact indicator of arrhythmia before late-stage investment.
 
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Regional trials
GCP Compliance

Wrong Turn


Russian regulators found 280 violations of Good Clinical Practice at 83 research sites during 2011-2014. Highlighting the shortcomings – and comparing the non-compliance with the West – Yuri Afonchikov of Synergy Research Group and Artem Poltoratskiy from Petrov Research Institute of Oncology offer advice to foreign sponsors.
 
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Market Analysis: Asia-Pacific

Emerging Talent


Beyond China and India, numerous lesser known markets make up the larger share of the Asian pharma market. Questions have been raised over data quality and the infrastructure in these smaller countries, but sizeable growth is being boosted by government investment. Christophe Tournerie at ClinActis sets the record straight.
 
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data management & statistical analysis
eCROs

Data Based


Preferring analysis over algorithms, PAREXEL's Paul Evans and Xavier Flinois highlight how advanced technology used by eCROs can underpin feasibility of patient strategies and site selection – going some way to tackle the deficiencies from the lack of real-time standardised data.
 
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Financial Analytics

Pay Attention


Now thought to account for nearly half the total cost of a trial, investigator payments amount to critical – albeit currently untapped – data that could be used more strategically to forecast and evaluate costs throughout a study. Greenphire's Kyle Cunningham reports.
 
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Central Labs
Anatomic Pathology

Analyse This


The evolution of personalised medicine has increased demand for anatomic pathology in trials – and the central labs that perform these meticulous tests. Kathryn Bowers and Desa Rae Pastore at ACM Global Central Laboratory consider how pathology – an art as well as a science – must rise to the challenge.
 
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Cancer Therapeutics
Gynaecologic Cancer

Female Focus


It has been a bleak outlook for the 95,000 women in the US affected by gynaecologic cancers each year, with a lack of new drugs being approved for these diseases. But, as Jason D Hurt at Medpace suggests, this trend now looks to be reversing, providing trial designs and patient enrolment stay top of mind.
 
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Non-Small Cell Lung Cancer

Points of View


Computed tomography has been the mainstay of imaging-based detection, but in the field of non-small cell lung cancer – one of the most dominant forms of the disease – novel tools and techniques are emerging to support the take-up of genomics-based therapies. Amit Mehta from Intrinsic Imaging has more.
 
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Trial Design
Clinical Endpoints

On the Level


A primary measure of a drug's success or failure, clinical endpoints are a lynchpin in the R&D process. Rachel Swierzewski from ICON and Telerx's Adele Mueller explain how studies can utilise these independently assessed disease- or treatment-related events.
 
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Interview
Industry Interview

Thinking Allowed

A Phase 3 pain study may have highlighted the implementation issues of ePRO, but Emily Cantrell from Rho tells ICT that wider adoption of this technology is on its way.
 
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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August, and November

News and Press Releases

Turkish Cargo includes Sheremetyevo Airport near Moscow to its cargo flights network.

As the fastest growing brand among the global air cargo carriers with its extensive flights network, Turkish Cargo included Sheremetyevo Airport (SVO), known as being the most important airport in Russia in terms of cargo activities, to its direct cargo flight destinations network.
More info >>

White Papers

Customising the Cold Chain

World Courier

Of all the statistics emerging around the global pharmaceutical industry this year, two big numbers capture the attention of both manufacturers and their logistics partners: $248 billion, the amount the “BRIC” nations (Brazil, Russia, India and China) are poised to account for in pharmaceutical sales for by 2016; and $8 billion, the amount global pharma will spend on cold chain logistics in 2014. Why are these two numbers so noteworthy? They demonstrate that as R&D goes, so goes logistics. As products evolve to meet demands for more targeted therapies, demand for more targeted logistics solutions grows as well. And that means a need for customization for everything from clinical trial samples to finished product.
More info >>

Industry Events

SCOPE Europe – Summit for Clinical Ops Executives Europe

17-18 September 2019, Barcelona, Spain

Building on the success of its long-running US-based counterpart, Summit for Clinical Trials Operations Executives Europe (SCOPE Europe) is a two-day event serving clinical innovation leaders, clin ops execs, functional heads, category managers, and those responsible for the planning and management of clinical trials in Europe and the Rest of the World. The event will feature opening and closing plenary keynote sessions, five conference tracks, interactive breakout discussion groups, and networking. It is an opportunity for leaders from large, mid-sized, and small pharma, specialty pharma, biotech, vendor companies, and academic research centers to come together to share best practices and discuss the new era of analytics-driven and patient-centric trials.
More info >>

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