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At the 2014 American Society of Hematology meeting, Professor Peter Hillmen from the University of Leeds discusses clinical trial strategies employed in the United Kingdom to shorten the time required to identify the safety and efficacy of drugs used to treat CLL, both alone and in combination.
Take Away Points:
- Clinical trials for relatively rare cancers such as CLL have traditionally taken a long time to plan, get approval, accrue patients and get results.
- This bottleneck slows new drugs getting to market and the clinical science moving forward.
- This was less of a problem when there were fewer drugs to treat CLL.
- With so many new possible treatments, we need a faster way to test the safety and efficacy of therapies both alone and in combination.
- TAP (Trials Acceleration Programme) is an attempt to safely speed up research.
- One way to accelerate the research is through the use of extensive ancillary blood testing to help quickly predict what therapies make the most sense to further explore.
In the first of a three-part interview, Professor Hillmen begins to outline the many intertwined clinical trial strategies employed in an attempt to sort out the best ways to quickly answer important clinical questions such as which combinations of drugs make the most sense.
The TAP or Trials Acceleration Programme uses small patient groups and assesses results in as soon as six months by using multiple telltale markers in the blood, rather than waiting for what is sometimes years to see a statistically survival difference play out.
With all the new drugs and all the potential permutations and combinations, we simply don’t have enough time or patients to do it all the old way. TAP offers coordinated resources across the UK, including help with the extra staff and the extensive bureaucratic machinery needed to set up and to run a clinical trial. The goal is to reduce the amount of time from the opening of a clinical trial to when we see results. In the past, it could take as long as ten years, but in the future it could take two years or less.
But I will let Professor Hillmen explain it. His excitement and pride are palpable.
Brian Koffman 5/7/15