ALS Advocacy

ALS Advocacy
Lou Gehrig's Disease - Motor Neuron Disease - Amyotrophic Lateral Sclerosis
Thought it had been cured by now? Still no known cause. Still no cure. Still quickly fatal. Still outrageous.

Tuesday, August 28, 2012

We All Have A Lot To Learn

There have been many online discussions of some serious ethical dilemmas regarding people with ALS in two recent clinical trials.

The rules of the trials seem pretty simple, yet there are a lot of things that can happen that make the interpretation of those rules a matter of life and death for people with ALS.  They deal with the ticking clock and a future with no great choices.  It's more than troubling when a good choice unanticipated when the rules were written is taken from them.

I now realize that I have a lot of questions about how a clinical trial's rules came to be.  I'm sure there are a lot of people involved -- the pharmaceutical company, scientists, the clinical investigators, the FDA -- oh, and patients -- and I have a lot to learn about who does what.

  • Who sits down and writes the rules for a clinical trial?
  • How many people are involved?
  • Who has input into the inclusion and exclusion criteria?
  • Who approves the rules?
  • Who pays for the rules of the clinical trial to be written?
  • How long does it take to write the rules?
  • At what point does the FDA see the rules?
  • How are clinical trial sizes established?
  • Can any of the rules be clarified once the trial starts?
  • Who handles the interpretation of the rules when a question arises?
  • Who has the final say on an interpretation?

One thing I have learned in the last few weeks is that those many people involved all have a lot to learn from one another.


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