International Clinical Trials |
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Comment from the Editor
As many articles in this edition highlight, the industry is reshaping in the face of multiple pressures and demands – prompting Graham Hughes to offer his take on the coming reformation.
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Regulatory Update
Europe in Harmony?
The incoming Clinical Trials Regulation will simplify and speed up trial applications and approvals across Europe. But, as Peter Kennerley and Clara Ezed from Emas Pharma make clear, potential hurdles lie in wait, such as get-out clauses and differences in medical practice and language.
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Drug Safety
Active Ingredients
Doing business in new markets brings greater exposure to safety and regulatory risks. Chitra Lele at Sciformix examines how this is prompting a shift to a more proactive pharmacovigilance model with data analysis, stakeholder input and benefit-risk balance at its core.
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Site Performance
Going Metric
A shared, consistent set of standards and metrics to assess the performance of clinical research sites is moving closer due to an ongoing multi-stakeholder initiative. Greg Koski and Mary Tobin at ACRES, and Eve Shalley at Essex Management report.
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Clinical Support
Local Economy
Outsourcing pharma and biotech firms will become more reliant on clinical support services with the expected explosion of monoclonal antibody products. Alcura UK's Gad Neama outlines how help across all study phases can streamline the trial and approval pathway.
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Electronic Data Capture
Power Source
Clean, reproducible site data remains a bedrock of clinical research, but with traditional methods feeling the strain, eSource is stepping forward. Ann Neuer at Medical deScriptions explores how it not only eliminates transcription errors, but also enhances risk-based monitoring.
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eClinical Platforms
CTMS – The Decade Ahead
The clinical trial management system is much more than another product in the eClinical suite, and it must now be future-proofed to meet new trends. Predicting a move to a modular structure, PAREXEL's Liz Love considers the needs of end-users in the years ahead.
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Bio Investment
Cash Points
Marketed as ‘Where great minds, smart money and key dealmakers meet’, this year’s BioTrinity conference explored biomedical investment trends and the growing alignment between pharma and venture capital. Graham Hughes was there.
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Focus on Russia
Central Resources
Formed in the late 1990s, Russia's clinical trials market remains a highly centralised system, with oncology studies taking the lead. Yuri Afonchikov at Synergy Research Group, and Artem Poltoratskiy and Petr Krivorotko from Petrov Research Institute of Oncology offer a snapshot.
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BRIC Markets
Ups and Downs
The BRIC markets are in flux – and Big Pharma is trying to keep up. Aside from the continued growth of China, initiated trials in Brazil, Russia and India are in decline, yet some companies still see rich pickings. Beth Nuskey at Thomson Reuters has an assessment.
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Data Collection
Tech Track
Systems to eliminate the variability in data collection have yet to fully reach the clinical trial space, but the need for predictable, reproducible measurements means advances are edging closer. Abraham Gutman from AG Mednet looks at the technology toolbox.
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Lab Innovation
On the Button
'Making innovation count' should be the new mantra for global labs. As Paul Travis of Medpace explains, they can offer the industry vital support to integrate data, enhance study performance and maximise R&D spend.
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Trial Engagement
Empowering Patients
Lack of patient engagement is costing the pharma industry dear, so putting their views and values at the heart of clinical R&D is now seen as key to the healthcare revolution. Ulrich Neumann at eyeforpharma sets a roadmap for change.
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CRO Training
Talent Show
Problems recruiting clinical research associates is hastening a resourcing crisis for CROs – leading Martin Robinson from the International Academy of Clinical Research to call for new competency based training schemes.
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Adaptive Methods
For a Change
Cautiously optimistic might best describe the position of industry and regulatory agencies towards adaptive trial designs. Weighing the benefits and concerns, Ron Marks and Mark Shapiro of Clinipace Worldwide provide an update.
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Trial Design
Slowing Down to Speed Up
There is increasing recognition that using adaptive designs in Phase 2 trials can minimise the risk of product failure at a later stage and add significant value to eventual licensing transaction or exit, advises Phil Birch at Aptiv Solutions.
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Industry Interview
Thinking Allowed
Chris Hamilton of CROS NT tells ICT about the European law on data transparency coming pharma's way in 2016 – and how to prepare.
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