spacer
home > ict > Spring 2015
PUBLICATIONS

International Clinical Trials

ict
Spring 2015

   
Text
PDF
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.
 
view
download pdf
bullet
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf

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.
 
view
download pdf
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.
 
view
download pdf

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.
 
view
download pdf

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.
 
view
download pdf
   
spacer
Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August and November

News and Press Releases

MRC Technology monetises royalties on cancer drug Keytruda (pembrolizumab) to expand medical research activities, with a fund managed by DRI Capital


More info >>

White Papers

Successfully managing the unique demands of cell therapy supply chains

PCI Pharma Services

Cell therapy professionals joined a specialist webinar by industry experts from PCI Clinical Services and TrakCel, addressing the unique complexity of an autologous therapy supply chain. Hosted by European Pharmaceutical Manufacturer magazine, the webinar was delivered by Rachel Griffiths, Associate Director, Technical Services, PCI Clinincal Services, and Dr. Matthew Lakelin, Vice President, Scientific Affairs and Business Development, TrakCel . Here, we present the white paper from that webinar event.
More info >>

Industry Events

BIO-Europe® 2017

6-8 November 2017, Messedamm 26 14055 Berlin Germany

The 23rd annual BIO-Europe® event is the largest biotechnology partnering conference held in Europe. Over 3,800 global decision makers from biotechnology, pharma and finance annually attend BIO-Europe to identify new business opportunities and develop strategic relationships. Business development executives and dealmakers consider BIO-Europe a must-attend event and an effective business strategy enabling them to meet and present to numerous potential partners. BIO-Europe features the industry’s most advanced web-based partnering system enabling delegates from all parts of the biotechnology value chain to quickly identify, engage and enter into strategic relationships that drive their business successfully forward. BIO-Europe's world-class workshops, panels and active exhibition along with thousands of prescheduled one-to-one meetings make this event an unrivaled forum for companies across the biotech value chain to meet and do business.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement