International Clinical Trials |
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Editor’s Comment
Introducing this edition of ICT, Graham Hughes highlights articles on the new era of data transparency and work to tackle metabolic health conditions.
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Tax Relief
Inside the Box
UK life sciences companies are still to fully realise the benefi ts of the Patent Box, perhaps because this tax relief regime for patented products is still bedding in – but they should sign up now, advises Rhian Osborne at Greenaway Scott.
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Regulatory Submissions
In the Cloud
With global submissions becoming an ever-more complex process, Rik van Mol from Veeva Systems describes how pharma is turning to multitenant cloud-based platforms to speed up applications and keep companies in sync with worldwide health authorities.
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Site Payments
Automatic Drive
Beyond simply reimbursing investigator sites quickly, automated payment systems also offer other advantages to boost trial performance, particularly for complex, later-phase studies. Heather Schultz at Clinverse fills us in.
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Risk-Based Monitoring
Quality Control
It may have had limited application to date, but quality risk management can be used to enhance best practice across drug development. Nicole Stansbury and Stephannie Perrin of PPD explain how risk-based monitoring is taking advantage.
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E-Patient Engagement
Rare Insights
Information on the location and prevalence of people with rare diseases is often hard to come by, but e-patient data and online analytics can provide granular insights that enable more targeted trials. Pete Chan of Tudor Reilly Health reports.
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Emerging Markets
BRIC by Brick
Entering the BRIC markets often makes strategic sense but, recommends Debashis Ghosh of Tata Consultancy Services, it is essential to fully explore the drivers and constraints to decide which is best for your business.
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Inherited Disorders
Ironing Out Thalassemia
Transfusion-based treatments for the rare blood disorder, thalassemia, raise the risk of iron overload to patients – particularly the high number of sufferers in the Middle East and North Africa. Rani Abraham at ClinTec calls for fresh research impetus.
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Asia-Pacific Studies
Border Crossing
Many sponsors are cashing in on the population growth and healthcare infrastructure in the Asia-Pacific region for their clinical R&D but, emphasises PCI’s Rich Nelson, care is needed to navigate the unique country-specific differences that impact on logistics and supply.
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Diabetes Research
Early Warning
The rising clinical failure rate for drugs targeting diabetes highlights the need for improved preclinical evaluation to better assess the molecular mechanisms of the disease and shape later Phase 2 studies. Jim Wang at Crown Bioscience offers a case study. |
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Data Analytics
Prime Numbers
With the transparency debate prompting the industry to shine a self-appraising spotlight on itself, companies will learn how to better manage the vast – but currently disjointed – data reservoirs it has access to, says PRA’s Gareth Adams.
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Data Disclosure
Transparency Impact
Opening the door to greater trial transparency will help drive clinical R&D and build trust. But, as Mathias Poensgen, Jessica Schell and Simon Wilson at ArisGlobal explain, pharma must also be alert to the implications of too much patient-level data being disclosed.
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Metabolic Diseases
Meta Data
The risk factors that make up metabolic syndrome are now more clearly understood and relatively easy to detect thanks to today’s methodologies and instrumentation. Tatiana Souslova from ACM Global Central Laboratory explores further.
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Laboratory Data
Local News
Tomasz Anyszek and Michal Dysko at Synevo Central Labs outline how demand for more sophisticated outsourcing in research is leading to locally-based central laboratory networks and decentralised services as a cost-effective way to overcome logistics hurdles.
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R&D Investment
Growth Fund
The lack of funding options has been stifling R&D and innovation in life sciences, but Mark Howard and Jodie Dennis from Charles Russell LLP raise hopes that a more healthy mix of alternative and traditional investment is returning to the marketplace.
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Breast Cancer
Mind Altering
The much-awaited results of the MINDACT trial are coming soon. Fatima Cardoso at Champalimaud Cancer Center, Miguel Martin at Hospital General Universitario Gregorio Marañón, and Gustavo Werutsky at Hospital São Lucas consider what it could mean for genomic signatures and chemotherapy.
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Cancer Diagnostics
Blood Pressure
Amid fears from the WHO of a cancer ‘tidal wave’, increasing attention is being focused on developing non-invasive blood-based tests to aid early diagnosis and tackle the current shortfall in screening. Mark Eccleston at VolitionRx looks forward to their implementation.
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Recruitment and Retention
Brave New World
The Medical Research Network’s Graham Wylie calls for a shake-up to boost patient involvement in trials – reducing principal investigators and ineffective sites in favour of a more communityfocused system.
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Business Insight
Community Care
Exostar’s Richard Addi tells ICT about the information access and security issues as more companies come to rely on cloud-based communities.
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Industry Interview
Thinking Allowed
Complex medical device trials and operating in the current CRO landscape are among the talking points for John Potthoff of Theorem.
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