Clinical Trials Articles

The European attempt to boost the emergence of new therapies is starting to gain momentum. The EU rules that agreed in 2007 to create a standardized and centralized authorization process for advanced therapy medicinal products are coming into full effect, and the procedures that applicants have to follow are being more clearly defined.

The economic stimulus package approved by Congress in February provides more than $1 billion to support research on competing medical treatments. Although a fairly minor piece of the larger $789 billion American Recovery and Reinvestment Act of 2009 (ARRA), the provision set off a firestorm about using comparative study results to limit coverage of more expensive medicines.

New features address complexity of global submissions standards

Octagon Research Solutions (Wayne, PA) has updated its global submission document authoring template suite to include over 230 templates.

Senior clinical researchers have reacted strongly to an analytical article and commentary that are deeply critical of the drug evaluation process.

Leaders from both sides of the Atlantic shared the stage in late March to provide DIA EuroMeeting attendees with an update on the U.S.-EU Transatlantic Administrative Simplification Plan. Speaking on behalf of their agencies were Thomas Lönngren, executive director of EMEA, and Murray Lumpkin, MD, FDA's deputy commissioner for international programs.

In late March, the House Subcommittee of Oversight and Investigations released the results of its three separate sting operations carried out in an attempt to uncover malpractice within the IRB industry. These were conducted by the Government Accountability Office (GAO).

What Phase Gets the Most Dollars?
In Frost & Sullivan's latest U.S. CRO Market report, it noted that the overall U.S. CRO market had revenues of $9.77 billion in 2008, with projected 2015 revenues at $23.78 billion. Where were the growth spots for the CROs? One large area is early stage work.

This month, Applied Clinical Trials and its accompanying supplement, Oncology & Clinical Trials in the 21st Century, has bonus distribution at both ASCO (the American Society of Clinical Oncology) annual meeting, as well as the 2009 BIO International Convention.

Uma Arumugam, MD

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Michael Reffeitt
• Upon a recent promotion, Lori Ball will now serve as the vice president of global operations, sales, and marketing for BioStorage Technologies (Indianapolis, IN), adding to her prior responsibilities: operations, logistics, sample handling and processing, and IT.