International Clinical Trials |
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Data Transparency
Going Public?
Should all clinical trial data be made publicly available, or would this be an alarmist move that could cause mistaken safety concerns? Rupert Gilbey from Samedan Ltd heard both sides of the argument at a recent industry debate.
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Innovation in R&D
Box Clever
The UK government’s new Patent Box preferential tax regime recognises the strategic and economic importance of the life sciences industry. Nick Beckett at CMS Cameron McKenna fills us in.
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Home Trial Services
Inside Story
A new and powerful tool for improving recruitment and retention, home trial support can speed up trials and reduce patient burden. Graham Wylie at Medical Research Network outlines the nuts and bolts of this service.
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Project Management
Leading Edge
Eric Morfin at Critical Skills Inc examines the importance of nurturing future project managers and leaders in clinical trials, outlining the appropriate behaviour-based skills and styles.
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Patient Engagement
Get Connected
Mobile and digital technology can be used to capture clinical outcomes at the point of experience, helping pharma companies to engage with patients globally, in any language at any time. Tim Davis at Exco InTouch explains.
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Professional Standards
Live and Learn
A lack of competency-based qualifications for clinical research points to the need for internationally recognised accreditation. Martin Robinson at the International Academy of Clinical Research proposes a new framework.
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Patient Adherence
Missing Link
The lack of patient adherence recorded in many clinical trials leads Dorothy Smith at Consumer Health Information to ask: how safe is the prescribed dose of some drugs on the market?
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Investigator Grants
Forward Thinking
Linda Drumright at IMS Health considers the tricky issue of estimating investigator grants, emphasising the value of using historical performance benchmarks to more accurately forecast the costs.
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Progression-Free Survival
Under Review
An independent review committee can add value to the use of progression-free survival endpoints in oncology trials. A potential new approach is explored by Kristin Borradaile, Kevin Duffy and J Michael O’Neal at BioClinica.
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Phase 1 and 2a Trials
Early Action
International perspectives on a host of hot topics were shared at the recent Phase 1 and 2a Clinical Trials Conference, attended by Graham Hughes.
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Electronic Patient Data
ePRO Update
Electronic platforms could give a new lease of life to patient-reported outcomes for clinical trial endpoints. J Jason Lundy at the Critical Path Institute looks at the adaptation of paper-based instruments and what the future might have in store.
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Infectious Diseases: China
Eastern Time
Its large pool of treatment-naïve patients makes China a potentially strong market for clinical studies, although protracted approval timelines, cultural barriers and competition for resources are among the challenges. Steven Lobel, Carol Olson and Beth Tulip at PPD report.
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Asian Markets
Culture Trip
Amid the advantages of the Asian region, trial sponsors should ensure that results are not compromised by linguistic, cultural and behavioural differences, says Gary Muddyman at Conversis.
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ECG Measurements
Use and Principles of Automated Measurements
Tim Callahan at Biomedical Systems makes the case for the use of automated algorithms from electrocardiogram machine manufacturers and third-party vendors to ensure consistent, high-quality readings in early phase trials.
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Lab Selection
Balance of Evidence
Central lab partners are often selected based on company policy or previous work, rather than project-specific considerations. A Karelin, M Belotserkovsky, V Khokhlova and A Kumar at PSI set out a process for making the optimal choice.
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Industry Interview
Thinking Allowed
ICT quizzes Rory O’Hare at Greenphire about his concerns over global payments and realising its strategic potential.
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