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CenterWatch Monthly December 2009

Wednesday, December 2, 2009 07:32 AM

Maine Revises Clinical Trial Transparency Rule

The revised regulations, which went into effect Nov. 2, are an attempt to clarify the Maine’s requirements for clinical trial registration and results reporting and to make them more compatible with federal reporting requirements under the FDA Amendments Act of 2007, which called for a federal system that expands public access to data from clinical trials.

FDA, OHRP Guidance on Unanticipated Problems and Serious Adverse Events

FDA and HHS regulations require that unanticipated problems encountered in clinical trials be reported. The FDA regulations require investigators to report unexpected, serious adverse events to the sponsor and the sponsor, in turn, shall report these events to the FDA in an expedited manner.

Debate Intensifies Over Future Shape of Safety Reporting

Europe’s system of safety reporting continues to be plagued by a host of inconsistencies, and no stakeholders appear happy with the current mechanisms for handling suspected unexpected serious adverse reactions (SUSARs).

Eye On: Lymphoma

Lymphoma, a form of blood cancer in which white blood cells known as lymphocytes proliferate more rapidly or have a longer than normal life span, may arise in the lymph nodes, spleen or other organs, bone marrow or  blood.

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CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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