International Clinical Trials |
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Comment from the Editor
Graham Hughes sees in the New Year by highlighting a selection of articles from this edition, emphasising the need for speed in developing vaccines and other much needed therapies, and the crucial role of different types of data in ultimate trial success.
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Biomarker Strategies
For Good Measure
How can you develop biomarker-based tests efficiently without extra trials that add to development time and cost? The answer lies in appropriate selection, avoiding the pitfalls and looking to biobanks, argue Simon Goldman and Mike Fisher at Abcodia Ltd.
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Site Engagement
Face Value?
When it comes to investigator meetings to set out trial deliverables and get buy-in from site staff, is it best to stick to tried and trusted face-to-face meetings or to go virtual? Marny Bruce and Chuck Johnston of AXON Clinical Trial Services offer some advice.
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Outsourcing Models
Risky Business
Strategic alliances pose something of a catch-22: CROs need multiple partners to avoid risk, but this can lead sponsors to question the strategic nature of the agreement. With the market in flux, Chris Hamilton of CROS NT calls for a better long-term model that leaves the industry less vulnerable.
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eSource
Proof Positive
Across therapy areas – from vaccines to Alzheimer's to dermatology – electronic source data is having an impact. Case studies outlined by Ann Neuer at Medical deScriptions show how it goes beyond just cost savings and condensed timelines, with eSource now helping to drive clinical innovation and decision-making.
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Trial Master Files
Support System
Even though CROs are under pressure to provide higher levels of collaboration and efficiency, more than 80% use outdated methods to exchange critical trial documents. But a new survey, outlined by Rik Van Mol at Veeva Systems, suggests that a shift to cloud-based eTMF technology is coming.
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Biosimilars
Like Minded
Europe has led the charge in bringing biosimilars to market and, despite the difficulties in developing these therapeutic proteins, pharma companies are not put off. Casting a regional eye at Central and Eastern Europe, Magdalena Matusiak and Anna Baran from KCR explain the development route.
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Market Analysis: Russia
Federal Factors
Russia has been a rising star of clinical R&D for 20 years, but the slowdown in market growth and emerging competition might block further progress. Maria Bomer at Bomer Pharma Consultancy assesses the country's trial landscape and the mixed success of new regulation.
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Central Laboratories
Local Impact
Trials in Russia may have doubled in the last decade, but the costs and delays stemming from its import/export procedures can curb sponsor enthusiasm. Tomasz Anyszek and Michal Dysko of Synevo Central Labs suggest that locally-based central lab networks can help the country get back on track.
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Central and Eastern Europe
Uncharted Territory
Given that it is not 'on the map' for most study planners, Belarus is an undiscovered gem for trials beyond Phase 1. Pavle Vukojevic, Alexey Zarubov and Amira Al-Sendi at Pharm-Olam International consider how the clinical infrastructure and strong patient pool make it an attractive new frontier.
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Vaccine Development
Added Impetus
Adjuvants are key to ensuring the efficacy of modern-day vaccines – and a fertile area of research. Robert Lins of SGS Life Science Services examines the novel alternatives being tested, and calls for early comparative trials to further improve immunogenicity.
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Antibiotic Resistance
Up the Anti
Amid repeated warnings that we are heading for a post-antibiotic era, in which common infections and minor injuries once again become lethal, Susie Lunt reviews the efforts of the pharma and science communities to address the crisis.
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Data Integration
Multiple Choice
Pharma companies and CROs have to mine multiple data sources for information on investigative sites – a big task that often leads to poor decisions and inefficiencies in planning and feasibility. No wonder they are now turning to bespoke platforms and data sharing, say Claire Sears and Elisa Cascade from DrugDev.
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Statistical Analysis
Data Driven
When it comes to statistical programming, pharma companies are leaning towards an offshoring strategy to help realise cost advantages and more accurate analysis of trial data. Chitra Lele from Sciformix gives some tips on how to optimise and sustain a globally distributed model.
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Risk-Based Monitoring
Watch and Wait
With pharma eyeing risk-based monitoring as a more proactive, centralised alternative to 100% source data verification, Wipro Ltd's Hans Poulsen stresses the need to be fully prepared by putting in place a quality cycle of plan, do, check, act.
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Comparator Drug Supply
Trading Standards
Despite a new industry initiative on comparator drug supply, the trading and pricing concerns in this area remain a conundrum that pharma is yet to crack. David Allen from ADAllen Pharma contemplates where we are now – and the uncertain future.
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Feasibility Assessment
Probable Cause
Graham Wylie at the Medical Research Network takes aim at the flawed model of feasibility assessments, arguing for a more patient-centric approach that looks beyond inclusion and exclusion criteria, and harnesses the wealth of digital data to drive trial recruitment.
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Industry Interview
Thinking Allowed
The ever-changing needs of trials mean that integrated response technology must stay one step ahead through customisation and true functionality, says endpoint's Jonathan Dole.
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