Applied Clinical Trials-07-01-2012

Applied Clinical Trials

Risk-Based Monitoring Risky for Sponsors?

July 01, 2012

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In August last year, the FDA came out with its Guidance for Industry Oversight of Clinical Investigations-a Risk-Based Approach to Monitoring. Sponsors and CROs alike are still examining the document and discussing how best to move forward.

Fresh Doubts Cast Over Post-Marketing Trials

July 01, 2012

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Criticisms of the pharmaceutical industry's real motives for undertaking post-marketing studies have been made by a special report in the British Medical Journal.

Health Reform Declared Constitutional

July 01, 2012

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The main result of the Supreme Court decision upholding the Affordable Care Act (ACA) is that it ends all the rampant speculation and uncertainty about the future shape of the US healthcare system.

Ethical, Logistical Issues: Experts Outline Criteria to Justify Randomized Studies

July 01, 2012

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It's hard enough to conduct clinical trials for experimental medicines, but it can be even more difficult when patients already have access to the medicine outside the research setting.

Applied Clinical Trials Digital Edition - July 2012

July 01, 2012

Issue PDF

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Regulatory: Developing Biosimilars for a Global Market Subject Recruitment: Patient Interest in Clinical Trial Referral CRO/Sponsor: Functional Service Provider Model Also in this issue: Proposed Rule Changes in Europe Global Study Monitors Benchmarks Emergency Department Trials