Wednesday, April 22, 2009

Strategic Comparative Effectiveness Trials

Tony Dutta, senior vice president of operations at IDIS, recently wrote a great article in Applied Clinical Trials in which he describes the strategy pharma companies should put in place as the pressure mounts for them to conduct comparative effectiveness trials. Here's a brief recap of strategy he recommends.

Get strategic
To minimize delays that can evolve from financial implications, comparator sourcing strategies should include, "demand planning that can accommodate changes in the quantity of comparator drug needed in light of fluctuating patient enrollment or unexpected changes to a trial; changes in regulatory opinion, or temporary or permanent regulatory noncompliance by the source manufacturer; loss of the project's consulting global regulatory expertise; changes in global sourcing capabilities and logistics; and loss of connection to the comparator manufacturer via a sourcing specialist."

Timing is everything
A head start on planning is important as comparator drugs are like to be available from multiple places in multiple locations.

Single sourcing
Single Sourcing poses pros and cons, so sponsors should carefully evaluate risks before diving into this concept.

Read the full article

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