Ethics/Regulatory

Update of E6: The ICH GCP Guideline

Monday, August 1, 2016

The International Conference on Harmonisation’s (ICH) Guideline for Good Clinical Practice (GCP; document E6) is currently being revised. The FDA published the new version, which will be called E6 (R2), as a draft document in the Federal Register in June 2015. The draft contains numerous revisions that address changes in the scale, complexity, and cost of clinical trials since the previous version was adopted. Since clinical researchers have access to new technology and risk management processes that may increase efficiency and focus on relevant clinical trial activities, E6 is being amended to encourage the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, while ensuring that human subject protection and data integrity are maintained. In addition, the update includes changes to clarify standards on electronic records and essential documents. Ultimately, the new document is designed to help clinical researchers protect human subjects, maintain data quality and integrity, and properly document trial results. This article will highlight the key changes that affect research practitioners. These revisions are expected to be reviewed and accepted within ICH and then incorporated into the E6 document by the end of 2016.

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Alere hit with subpoena for Medicare billing practices

Thursday, July 28, 2016

Investors were temporarily shaken after news of a federal investigation into Medicare billing practices. Alere received a U.S. Department of Justice subpoena addressed to Alere Toxicology Services on July 1, 2016. The subpoena seeks records related to Medicare, Medicaid and Tricare billings dating back to 2010 for patient samples tested at the company’s Austin, Texas pain management laboratory.

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EMA suspends Semler’s medicines over flawed studies

Monday, July 25, 2016

The EMA has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, Bangalore, India. The Agency has also recommended that medicines currently being evaluated for authorization and which rely only on bioequivalence studies from this site should not be authorized until bioequivalence is demonstrated using alternative data. Bioequivalence studies usually form the basis for approval of generic medicines.

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EMA to revise guidance on first-in-human clinical trials after Bial trial deaths

Monday, July 25, 2016

The EMA, in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants. These changes are outlined in a new concept paper which has been released for public consultation. Comments on the proposals should be sent to FIH-rev@ema.europa.eu until September 30 using the form provided.

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