Applied Clinical Trials, Sep 1, 2012 - Applied Clinical Trials

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Applied Clinical Trials, Sep 1, 2012
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News
Regulators Must Modify Approach
By Philip Ward
Regulators must stop approving so many new drugs of very limited therapeutic value, and the European Medicines Agency (EMA) and other regulatory bodies should be fully funded by public money rather than relying on industry-generated user fees, according to an article published by the British Medical Journal.
Bridging US and China to Conquer Cancer
By Wancai Yang , Lingjie Guan
During the annual ASCO meeting in June, the US Chinese Anti-Cancer Association (USCACA) held its fourth annual meeting to discuss the emerging role of China in global clinical development of novel anti-cancer drugs.
More Transparency, Standards Urged for Research
By Jill Wechsler
Even though thousands of clinical trials are listed on public websites, and sponsors are posting results from more key studies, consumer advocates continue to press for broader public disclosure of information on research involving human subjects.
View from Brussels
Clinical Trials Funding on the Horizon
By Peter O'Donnell
An entire section of Horizon 2020 is devoted to health, demographic change, and well-being.
CTI Insights
Doing a Double Take on CRO Market Size
By Kenneth A. Getz
The outsourcing market is five times larger and receives a higher share of R&D spend than expected.
Feature Article
ePRO in Diabetes Studies
By Keith Meadows , Christine Hall
Conversion from paper to ePRO for an instrument designed to assess diabetes' impact on quality of life.
Global Supply Chain Management
By Mary Jo Lamberti , Mary Costello , Kenneth A. Getz
From tactical to strategic: tracking the evolution of global clinical supply chain management.
Business News
Business and News Update
By Hannah Becker
Industry news focusing on the people and organizations who work in the clinical trials profession.
A Closing Thought
Implications of Biosimilar Development
By Dirk Reitsma, MD
Demonstrating biosimilarity is highly dependent on the unique characteristics of the product.
Trends in Central Labs & Biomarkers
Multiplexing Advantages
By Andrew Botham
Illuminating the advantages of multiplexing for advanced biomarker testing.
We Still Love Paper
By Amy Young
Moving into electronic methods to facilitate laboratory collections for clinical trials.
Flow Cytometry
By Barry van der Strate
The use of flow cytometry can add value in Phase I studies.
A New Paradigm
By Michael George, MD , Joan Meyer
Practical approaches to new challenges and opportunities in inflammation trials.
Proactive Use
By Steven Lobel
Biomarkers help researchers develop new drugs faster and more effectively.

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