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International Clinical Trials

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Summer 2015

   
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Editor’s Comment

From industry's slow but certain adoption of risk-based monitoring, to the digital impact on trial methodologies – Graham Hughes highlights a selection of articles from this edition.
 
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Regulatory & Business Practice
GCP Audits

Check Points

Jeff Antos from The Weinberg Group offers a guide to Good Clinical Practice audits and how they can be accomplished to meet sponsor expectations, especially given the vast differences in the way they are sold and priced.
 
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TRIAL MANAGEMENT
Bring Your Own Device

Smart Thinking


It has been slow going for 'bring your own device' in pivotal trials, with industry and regulators erring on the side of caution. But we might now be at a tipping point, with concerns being addressed and conversation giving way to action. Susan M Dallabrida and Karin Beckstrom from ERT report.
 
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Site Performance

Aiming High


High-performing sites equals high-quality research, which is why an ambitious multi-stakeholder initiative is developing much needed global standards for the accreditation of clinical sites to drive excellence. Arti Bajpai, Greg Koski and Mary Tobin at ACRES provide an update.
 
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RBM Implementation

Worth the Effort

Risk-based monitoring promises big savings in research time and cost, yet it is a major change for the industry, with project teams and site staff struggling to adopt and adjust. PPD's Nicole Stansbury outlines how a sponsor-CRO working group can ease the transitional pains.
 
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Site Documentation

On the Record


With digital content and electronic files now commonplace in trials, document risk-based monitoring is the logical next step. Betsy Fallen at Phlexglobal describes how the process is capable of being adapted to the essential documents stored by institutions and investigators.

 
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eCLINICAL
Electronic Data Capture

Data Values


The industry may be convinced by the benefits of electronic data capture, but lingering concerns over the upfront costs have hampered wider adoption. Glenn Keet at Clinovo argues that new offerings mean many of the perceived barriers are no longer relevant.
 
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Regional trials
Market Overview: UAE

United by Research


Offering a snapshot of the United Arab Emirates, Adhiti Sharad Kumar outlines how its regulatory set-up, which helps maintain ethical, good clinical practice-compliant studies, is catching the eye of global pharma.
 
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data management & statistical analysis
Patient-Centric Solutions

Listen Up

Today's ePRO solutions are helping make the patient-centric philosophy a reality, delivering direct feedback and data straight from patients' fingertips. Rauha Tulkki-Wilke at CRF Health says it is a 'win-win', bringing better designed trials and more satisfi ed participants.
 
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mHealth Technologies

On the Go


Tech-savvy patients are providing rich, real-time data for trials as the mHealth revolution marches on. There may still be outstanding questions around privacy but, as Adam Curran of ArisGlobal explains, smartphones are the new medical device.
 
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PRO Data

Reaching Out


The value of patient-reported outcomes data that can address the cost and quality of healthcare is firmly established in drug development. But while it gives real-world evidence, beyond the safety and efficacy data from trials, there are hurdles to address, says Chitra Lele from Sciformix.
 
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Training & Development
Staff Competency

Up to the Job?


Lack of competence among clinical research staff can scupper a trial and jeopardise the rights and safety of patients. But, as IAOCR's Martin Robinson recognises, the industry is wising up to the use of competency frameworks that objectively assess and manage an individual's performance.
 
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Reviews
Event Review: DIA EuroMeeting

State of the Union


The 27th DIA EuroMeeting in Paris explored all manner of innovation – including the electronic health record revolution and Big Data invading life sciences – although regulatory affairs was a dominant presence. ICT's Graham Hughes reports.

 
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Trial Design
mAb Trials

Fail Safe


A pivotal study is looking to target diseased cells while sparing healthy tissues, to tackle the most common malignant myeloid disorder in adults – and there are substantial design issues to sidestep. Dragan Cicic and David Gould of Actinium Pharmaceuticals have more.
 
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Interview
Q&A: Nucleic Acid Therapeutics

Full of Life


With nucleic acid therapeutics set to rekindle drug discovery efforts for rare and multi-system diseases, Marina Biotech's Michael French tells ICT it is only a matter of time until we see multiple approvals on the market.
 
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Q&A: Statistical Monitoring

Central Time


Smart algorithms are far better than humans at detecting data issues, says Marc Buyse of CluePoints. In conversation with ICT, he sets out how centralised statistical monitoring can be an engine for a more effective risk-based approach.
 
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End Point

Hitting the Headlines


In his new closing column, Graham Hughes says pharma's efforts to rebuild a battered reputation are not being helped by misleading media reports that fail to register its role in breakthrough R&D.
 
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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

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