Ethics/Regulatory

Advancing patient protection through proposed Common Rule changes for informed consent

Thursday, September 1, 2016

Research practitioners eagerly anticipate finalization and publication of the revised U.S. Federal Policy for the Protection of Human Subjects, known as the Common Rule, which is scheduled to be released in September 2016. Many experts speculate that the revised policy may not be published as expected, yet there appears to be consensus that change in the rules governing human subjects is inevitable; the question remains as to what will be the final rulemaking and the impact on research practice. More than five years have passed since the impending change was announced in an Advance Notice of Proposed Rulemaking (ANPRM) on July 26, 2011 [FR 2011; 76(143): 44512-44531]. After consideration of substantive public debate, the U.S. Department of Health and Human Services and 15 other Federal Departments and Agencies published a Notice of Proposed Rulemaking (NPRM) with prospective revisions to the Common Rule on September 8, 2015 [FR 2015; 80(173): 53933-54060]. Stakeholders have carefully reviewed the proposed revision, provided essential feedback during an extended open comment period, and continued to consider the implications of potential new requirements as they await publication of a final rulemaking.1,2

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Theranos to appeal CMS sanctions

Monday, August 29, 2016

Theranos, a health technology company, has filed a notice of intent to appeal the sanctions that the Centers for Medicare and Medicaid Services (CMS) imposed last month on the company’s Newark, California, lab.

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GSK deal with Italian Medicines Agency highlights performance-based curative model

Monday, August 29, 2016

GlaxoSmithKline (GSK) has signed a pay-for-performance deal with the Italian Medicines Agency (AIFA) to boost usage of Strimvelis, the pharmaceutical company’s gene therapy treatment developed for ADA-SCID, a rare genetic disorder in children. The key to the contract, however, is that the drug must work. If treatment doesn’t provide a cure, GSK must return a portion of the funds paid by AIFA based on the terms of the agreement.

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EMA releases data integrity guidance

Monday, August 15, 2016

The EMA has released new good manufacturing practice (GMP) guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines. Regulators rely on these data to evaluate the quality, safety and efficacy of medicines and to monitor their benefit-risk profile throughout their life span. Controlling of data records helps ensure that the data generated are accurate and consistent to support good decision-making by both pharmaceutical manufacturers and regulatory authorities.

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ICER addresses misconceptions about value assessment goals and methods

Monday, August 15, 2016

The Institute for Clinical and Economic Review (ICER) has released a new publication to support the ongoing public conversation about its goals and the methods for evaluating the value of new drugs, devices, and other health system innovations. This publication, “Addressing the Myths About ICER and Value Assessment,” answers questions about ICER’s history, mission and methods while addressing misperceptions that may impede the kind of collaboration that is at the heart of ICER’s work.

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Principal investigator charged for insider trading

Monday, August 15, 2016

It’s rare for a principal investigator (PI) to face insider trading charges based on confidential developments in a clinical trial. But earlier this month, Edward J. Kosinski, M.D., a PI and president of Connecticut Clinical Research, was indicted on two counts of securities fraud by a federal grand jury in Connecticut for allegedly trading shares of Regado Biosciences in 2014 after receiving non-public information about the clinical trial from the project manager.

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EMA publishes adaptive pathways report

Tuesday, August 9, 2016

The EMA has published a final report on the experience gained during its pilot project on adaptive pathways, a product development concept for medicines that address patients’ unmet medical needs.

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