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PUBLICATIONS

International Clinical Trials

ict
Winter 2014

   
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Comment from the Editor

A turning point for antibiotics, diagnostics partners and patient motivation – Graham Hughes picks out a few of the articles and themes from this edition.
 
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Regulatory & Business Practice
Antibiotics R&D

Back to Health

A turbulent period for antibiotics development could be drawing to a close. Jon Bruss and Brian Murphy at Medpace describe how the public health crisis over multi-drug resistance has triggered an R&D surge by smaller biotechs and regulators.
 
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TRIAL MANAGEMENT
Companion Diagnostics

Breaking News

Pharma has struggled to live up to the lofty goals set for companion diagnostics but, as Alan Wookey at LabCorp predicts, increasing collaborations and a regulatory rethink of laboratory-developed tests have heightened expectations that more approvals are coming.
 
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Adaptive Designs

Changing Priorities


Growing steadily over the last decade, adaptive designs are being used for studies across industry and considered for new treatment assignments. Shyama Ghosh and Alvaro Arjona at Thomson Reuters provide an update on their use.
 
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Study Feasibility

Get Started


The cornerstone of a successful clinical trial, feasibility assessment enables CROs to address risks and delays in start-up and patient enrolment before a study begins. A Savateyev, M Belotserkovsky, D Palumbo and K Moscicka at PSI explain.
 
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Sample Integrity

Piece of the Action


As vital scientific assets for current and future research, clinical trial samples must be properly handled, from collection to transport to storage. Lori Ball of BioStorage Technologies makes the case for a strategic sample management plan to be considered upfront in the study design.
 
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Clinical Trial Outsourcing
PCT Congress 2013

Strategic Review


Assessing the future outsourcing landscape, the recent Partnerships in Clinical Trials Congress found that, despite some successes, the tensions and differences between sponsors and CROs continue to hamper a truly strategic approach. Graham Hughes reports.
 
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Functional Services

Pick and Choose


Functional service provider partnerships appear the way ahead for some sponsors, with this ‘cafeteria’ style of outsourcing specific services proving more flexible than full-service models. Dawn Edgerton from Rho gives some advice on finding CROs that are the right fit.
 
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eCLINICAL
Patient Engagement

Personal Touch

‘Bring your own device’ technology is the next step for pharma as it continues to harness mobile and digital platforms to enhance patient engagement and adherence in trials. Judith Teall at Exco InTouch explores how familiarity breeds success.
 
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Clinical Trial Supply & Packaging
Investigational Products

Patient Voices


The first-ever survey of patient experiences with investigational medicinal products reveals high levels of satisfaction, while also pointing to the need for more customised materials. Esther Sadler-Williams and Michelle Foust from ISPE’s project team outline the findings.
 
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CLINICAL THERAPEUTICS
Alternative Medicine

Yes, we CAM

From mind-body medicine to vitamin supplements, complementary and alternative treatments are gaining in popularity – prompting the need for greater awareness of how they interact with products and patients in trials. Marcin and Martyna Stefanowicz at Trial-Med explain.
 
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Trial Management & Outsourcing
Translation Services

About Time


Despite widespread outsourcing of translation services, pharma is still being hit by additional layers of cost and resources stemming from the handling and verification of translated documents. Matan Topper-Erez at TransCom Global recommends some new practices.
 
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Regional trials
Outsourcing: Southeast Asia

Into the East


Building on its Phase 2 and 3 capabilities, Southeast Asia is improving its early-stage trial set-up, infrastructure and regulation – making this fast-expanding market a winning ticket for multinational pharma. Nick Beckett and David Pountney at CMS set the scene.
 
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data management & statistical analysis
Risk-Based Monitoring

Vital Statistics


Increasingly favoured by regulators, central statistical monitoring can better interrogate study data, identifying anomalies early while also minimising risks and costs. Little wonder, says Marc Buyse at CluePoints, that it looks set to overtake traditional site-based practices.
 
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Clinical Trial Software

Level Best


Abraham Gutman at AG Mednet looks forward to the evolution of trial software, with the industry primed to further refi ne systems to take imaging data and more advanced analytics into new territory.
 
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Patient Recruitment and Retention
Study Retention

Staying on Course


Given that upwards of 40 per cent of subjects can stop their participation in a trial, retention is surprisingly overlooked. Elizabeth Puller and Liz Moench at MediciGlobal offer some tips on how to shape an effective retention programme to ensure a study remains on track.
 
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Interview
Industry Interview

Digital Direction

Nick Halkitis from Access to Patients tells ICT how digital recruitment and multi-channel marketing are coming to the rescue of clinical trials.
 
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Industry Interview

Source Code

Flexibility and know-how before, during and after a study are necessary to ensure comparator sourcing stays ahead of the game, advises Nadia Whittley of Pharmarama.
 
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Industry Interview

Thinking Allowed


Nuala Murphy, ICON Clinical Services’ new President, outlines how effort, expertise and technology support strong business decisions.
 
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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

Consultancy Expands at RSSL

Reading Scientific Services Ltd (RSSL) has appointed Sarah Marshall as its new Head of Consultancy Business
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White Papers

Working Towards a Standardised Identification Solution

Packaging Coordinators, Inc.

The security of the pharmaceutical supply chain is an issue of growing concern, with recent reports addressing its vulnerability to counterfeiting. The complexity of the European supply chain is one of the key factors of this counterfeiting pandemic, with millions of medicine packs being moved around the EU, annually. Aside from this, fragmentation has resulted in decreased transparency in the supply chain and increased difficulties to track and trace medicines, leading to significant threat from counterfeiting. As a key source of income for the European economy, it is essential that the supply chain remains safe and free of counterfeits. A significant stumbling block within the industry remains to be the lack of a unified, single‐source pan‐European or indeed global database where scanned bar codes on drug packaging can be verified at point of dispense. At some point in the future the pharmaceutical industry, regulatory bodies, clinicians and retailers will need to join forces to overcome this.
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Industry Events

10th Pediatric Clinical Trials

11-12 June 2014, Philadelphia, PA, USA

The10th Pediatric Clinical Trials Conference will provide executives with successful tools and best practices to effectively submit a PIP that meets FDA and EMA regulations, leverage clinical pharmacology data into data used in a pediatric clinical trial design, utilize unique recruitment tactics to improve participation and retention in clinical trials, and expedite drug development for the pediatric population.
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