news roundup
The European Organization for the Research and Treatment of Cancer (EORTC) has selected Almac Diagnostics as its preferred partner for molecular profiling of cancer patient samples collected by EORTC clinical trials, including SPECTA (Screening Patients for Effective Clinical Trial Access), a pan-European Cancer network. Almac Diagnostics will receive and process patient samples across multiple disease types from various locations across Europe, from its facility in Craigavon, Northern Ireland.
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CTA: Dive into Almac Clinical University
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The 505(b)(2) approval pathway for new drug applications in the United States, aimed at avoiding unnecessary duplication of studies performed on a previously approved drug, has not led to shorter approval times, according to Tufts CSDD. Specifically, Tufts found the percentage of 505(b)(2) drugs approved on the first review cycle was substantially lower than for all NMEs.
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Clinical Trials, Technology and Transformation
Acquire insights from 70+ influential industry leaders touching on technology innovation, mHealth, patient-centricity, effective collaborations, reducing costs and more at T3: Trials, Tech and Transformation, May 11-12, 2017 in Orlando, FL. Act now as early registration rate deadline is March 17th. Want more incentive? Save an additional $250 off current rate. Use Code: T3ACT.
 Click here for further details |
CROS NT, previously a biometrics-only CRO, announced the acquisition of the clinical division of PM Clinical Limited, which expands CROS NT's service offerings by adding regulatory consultancy, study design, feasibility, clinical project management and monitoring.
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IRT EUROPE – Interactive Response Technologies in Clinical Trials
4-5 April 2017 | Hilton Paddington | London, England
Leverage IRT to Enable Innovative, Flexible and Efficient Supply Chain Management for Clinical Trials
 www.cbinet.com/irteu |
The survey will evaluate how endpoint adjudication is impacting study design, and uncover operational challenges with endpoint adjudication and endpoint adjudication outcomes.
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Improving Clinical Trial Transparency, Collaboration and Efficiencies
Live Webinar: Wednesday, March 29 at 11:00am EDT
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Use Challenge Trials Effectively in Clinical Studies: Lessons Learned from H3N2 Influenza Virus
Live Webinar: Tuesday, March 28 at 3 pm CEST and Thursday, April 6 at 10 am EDT
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Articles
The expanding role of incentives is a healthy trend in an industry defined by high costs and the pressure of project deadlines, and these agreements between drug makers and their clinical research providers have matured significantly in recent years — to each party's mutual benefit.
This article offers a historic retrospective on the rise of patient advocacy groups and their effect on the drug development process.
Oncology
Recent rare disease symposium in the EU brought to light the very real challenges between patients, payers, reimbursement strategies and regulatory authorities in developing and providing for treatments for rare disease.
The unique mechanism of action of immuno-oncology treatments necessitates rethinking of traditional clinical trial endpoints--usually overall survival. However, achieving that endpoint requires years of study and would delay the approval of life-saving or extending treatments. Thus, drug developers are using surrogate endpoints to monitor the effectiveness of immunotherapies.
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Blog Posts
A recently released grant-funded study out of Brussels, included researchers reviews of scientific literature, less formal literature, legal analysis, interviews with stakeholders and an expert meeting. The report includes the prevalence and incidence of off-label use, its drivers, as well as a description of the national regulatory and ethical frameworks governing off-label use across the EU. However, it does not provide any recommendations.
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Are Local IRBs Really Necessary?
On Demand
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All stakeholders – sites, inspectors, sponsors, CROs, and vendors - are welcome to take the non-commercial TMF Reference Model's state-of-the-industry 2017 TMF Survey, designed to provide insights for both paper and electronic trial document management. |
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