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International Clinical Trials

ict
Spring 2015

   
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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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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 defi ciencies 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 treatmentrelated events.
 
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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

Development and Commercialization of Antibacterial Drugs to Speed Up

LONDON – 31 March 2015 – The growing threat posed by multi-drug resistant gram-negative organisms (MDR-GNBs) is lending a sense of urgency to the development of antibacterial drugs worldwide. Upcoming regulatory reforms to lower R&D costs and provide incentives for new drug identification will create attractive opportunities for pharmaceutical manufacturers.
More info >>

White Papers

Clinical Trials in Russia Orange Paper: 1st Quarter 2014

Synergy Research Group

In summary, Russia remains a very popular geography for local, regional, and global pharmaceutical companies to conduct clinical trials. Sponsors mention the following reasons for conducting studies in Russia: 1. Fast patient enrollment due to the centralized medical infrastructure. 2. Nearly 100% patient retention 3. GCP trained and certified Investigative Sites generating high quality data 4. Low cost: Average per patient cost is 60% to 70% below US and European prices due to the low cost of Investigators and the high concentration of patients in therapeutically aligned medical centers
More info >>

Industry Events

Partnerships in Clinical Trials

22-24 April 2015, Boston Convention and Exhibition Center, Boston, MA

IIR’s 24th Annual Partnerships in Clinical Trials is the world's foremost event series for clinical development leaders and practitioners. This event draws 1100+ leaders from pharma, biotech & medical device companies, CROs, and third-party services providers in to network, learn, strategize and advance next practices in clinical trials across the globe.
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