May 14, 2012

Cancer Clinical Trials: How to get the new treatment

The most promising new treatments are tested in randomized trials, also known as phase III trials.  Usually a coin flip‑‑more likely a computerized equivalent‑‑decides whether each participant gets the new treatment or the current standard.  Since the new treatment wouldn’t get this far in research if it were not promising, it is not surprising that many people want to get the new treatment and not the old one.  Is there a way to do that?
No there isn’t at the beginning, and it is good to remember that when a randomized trial starts, we don’t know if the new treatment will really be better than the old. We all hope that it will, but history teaches us that some will and some will not.
There are four ways, however, that clinical trial participants may be able to get access to the new treatment even after a coin flip assigns them to the standard treatment:

  • Some randomized studies allow a crossover. This is a situation in which participants receiving a randomized treatment can later receive the treatment that was given to the other group of patients in the study.
  • If the new treatment turns out to be better while the study is under way, the trial is often stopped and the new treatment may be made available to all the study participants who did not receive it in the first place.
  • Once a study is completed and the new treatment is proven better, some companies offer a Compassionate Use Protocol, Early Access Program that makes the drug available on a limited basis until the drug gains FDA approval.  These are often available at the research centers that carried out the phase III study.
  • When a new drug is clearly a winner, FDA approval can come quickly (despite the commonly held belief that it takes a long time).  The FDA has approved drugs within several months of study results showing a compelling benefit to cancer patients.
While there are no “tricks” one can use to assure being assigned to one treatment group or another, there are a number of ways to eventually get access to a new cancer drug regardless of what the coin flip decides for us in the first place.  This is particularly true if the new treatment is confirmed to be a real improvement for cancer patients.

To learn more about clinical trials, take a look at our book.
To put a smile on your face see Larry's latest cartoon

(c) 2012 Tom Beer and Larry Axmaker

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