International Clinical Trials |
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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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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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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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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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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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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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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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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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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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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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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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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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