International Clinical Trials |
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Comment from the Editor
From regulatory compliance to quality management, this edition of ICT offers a wealth of practical advice on the conduct and planning of early- and late-phase trials. Graham Hughes provides an introduction.
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Regulatory Update
New EU Clinical Trials Regulation
Trial
authorisations across Europe look set to be streamlined under the
incoming EU Clinical Trials Regulation, which will also bring a host of
other changes. Laura Brown at LB Training and Development Ltd outlines its scope and the key requirements. |
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IND Submissions
State Side Transitions
As
worldwide sponsors progress early studies to Phase 2, many turn their
attention to the US market – submitting an IND application for FDA
approval. While comparable with the clinical trial application in
Europe, there are extra criteria and important differences to negotiate,
as TKL Research's Roxanne Tavakkol explains. |
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Risk-Based Monitoring
Quality Review
María
Proupín-Pérez of PPH plus says that accurate early identification of
main study risks is fundamental when choosing the most appropriate
monitoring strategy – contributing to patient safety and quality
control, while helping avoid hasty and unwelcome rescue measures. |
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Trial Planning
Prep Work
Many life
sciences start-ups leave it late to plan for the trial phase, risking
design setbacks, regulatory delays and rising costs. Following the
principle of 'earlier is better', Nuala Ronan from Databean offers some advice on how to plan an effective study strategy. |
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Q&A: Human Factors Analysis
Site Specific
Human factors analysis has entered clinical research in the last 18 months, ICON's Clara Heering tells ICT, with sponsors starting to incorporate it into risk-based monitoring to help in risk mitigation at sites. |
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Quality Management
Action Packed
Patricia Santos-Serrao of MasterControl questions
whether clinical trial management systems go far enough, arguing that
quality processes should be strengthened across the wider study spectrum
– with CAPA a valuable tool to prevent and correct deviations. |
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Late-Phase Studies
Post Haste
Taking a new
drug beyond the highly controlled environment of a clinical trial,
post-authorisation safety studies can provide ongoing safety information
from real-world use. Jess Sohal at United BioSource Corporation has some tips on effective operational delivery. |
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Business Intelligence
BI the Way
Access
to critical study information through actionable visual business
intelligence reports can yield considerable benefits to clinical trial
performance and timelines, aiding decision-making and helping turn sites
into high achievers. Craig Morgan at goBalto explains. |
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eTMFs and Inspections
MHRA Inspections: How Ready Are You?
Cost savings and improved audit and inspection readiness continue to drive the adoption of electronic trial master files by sponsors and CROs, according to a new survey, with next-generation eTMF applications increasingly seen as a strategic asset. Rik van Mol from Veeva Systems reports.
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eClinical Technology
At the Source
From
minimising transcriptions errors to the potential for virtually instant
safety reviews, eSource is fast becoming the gold standard for source
data generation – and a streamlining force for trial processes. Ann Neuer of Medical deScriptions for Clinical Ink has more. |
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Falsified Medicines
Cracking the Code
Justin Schroeder from PCI finds
parallels between the randomised codes long used in clinical trials and
the broader serialisation requirements that pharma is rushing to meet
to help combat counterfeit drugs. |
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Supply Chains
The Last Mile
Millions of miles are travelled as temperature-controlled shipments are carefully monitored en route to investigator sites and patients but, says World Courier's Sue Lee, preplanning and supply chain flexibility are particularly important as medicines make the last mile.
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Anti-Infectives
Human Resources
Human
challenge studies, in which healthy subjects are deliberately exposed to
a virus before treatment, are increasingly crucial in generating
proof-of-concept data and optimising doses for field studies. Adrian Wildfire and Bruno Speder at SGS Life Science Services outline how they are evolving. |
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End Point
Choice Words
Health
literacy is closely tied to informed consent for trials but, comments Graham Hughes, ensuring patients have enough information to enrol and be
treated is far from straightforward. |
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Translation
Think Global
Will future
talent entering the clinical trials sector have the language proficiency
and cultural experiences needed to run successful global studies,
ponders Russell Goldsmith at Conversis Medical? |
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Protocol Compliance
Easier with ePRO
Exco InTouch's Laurence Burke examines how sponsors can use mobile ePRO technology to offset protocol complexity and tip the balance in favour of compliance – making life easier for trial participants and investigators, as well as helping ensure greater confidence in data quality.
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