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Compliance In Focus
Posted by Sandra Maddock on Thu, Sep 27, 2012

Top Five Reasons Cell Therapy Trials are Unsuccessful

Top Five Reasons Cell Trials are UnsuccessfulRecently the headline: “Why do Cell Therapy Clinical Trials Fail?” caught our attention. The blog stems from a presentation by Greg Bonfiglio on the topic at a recent conference. We found this quite exciting as the cell therapy field is growing here in the US and so is our interest in this niche of research.

Currently three main pillars of medicine exist- biologics, medical devices, and pharmaceuticals. While the FDA is still in the process of building a foundation of the cell therapy industry, there exists a need for this type of medical development to meet the needs of patients. Before any of these life-saving innovations can reach the public, they must meet the requirements for being proven safe and effective in clinical research- and have success in clinical trials.

The article lists five main reasons for cell therapy trial failure , and talking points by the blog’s author, Alexey Bersenev. These points are summarized below:

  1. Poorly chosen endpoints
    It is very difficult to measure therapeutic value of cell products. Wisely chosen primary and secondary endpoint could significantly increase success rate.
  2. Inappropriate patient population
    Some may want to treat all patients with same disease in order to target broader market. But in reality, only some subsets of patients will benefit meaning a targeted patient population is important.
  3. Control groups issues
    By definition, control groups are the standard by which observations are evaluated.
    Trials should be appropriately controlled, started from Phase 2. If control groups are added in late-stage of a trial they could abolish the efficacy.
  4. Discontinuity between research and commercial process
    Many great research findings simply will not translate when the manufacturing process is optimized.
  5. Bad trial management
    This may include many variables, such as lack of enrollment, lack of clinical operations experience, poor data management, and biases.

Check out the blog by Alexey Bersenev, which provides a lot of great information for current trends in cell therapy. What are your thoughts on this emerging pillar in medicine? Share your thoughts below!

Photo Credit:  CodonAUG



Topics: Cell Therapy Trials, Alexey Bersenev, Greg Bonfiglio, FDA


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