Dr. David Wright talks about the PROTECT III trial studying the use of progesterone for moderate to severe TBI and how you get patients' consent.
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The original trial--and classically the way a lot of emergency trials operate--
used something called proxy consent.
You have consent from the patient which in a head injury trial--by definition--you can't do.
The next best thing in the world of research is to find a proxy--or a family member
or a legally-authorized representative--to provide the consent.
Basically what they're doing is they're saying,
this is what we think the subject or our family member would want,
and we're okay with this study as well.
So, that's what proxy consent is about,
and in Protect I--the first study that we did--we used proxy consent.
The problem with proxy consent is that it takes time.
It can't be used if you've got to get a drug in really, really quickly.
We actually proved that in the Protect study--
and many other studies have shown this--
that it takes on average 4, 6--sometimes even more--hours
to sit down with the family member, describe first of all the condition.
The treatment team separately needs to go in and talk to them about the condition
and what's expected; and then a study team comes in and talks to them about
the study, the risks, and the benefits, and all of that takes time.
So for this study--for the Protect III clinical trial--
we are operating under a very, very special condition called
EFIC which is exception from informed consent.
This is an FDA-approved process, so we had to submit all of our materials to the FDA
to get their approval to do this.
Essentially what it means is that as soon as the patient meets criteria,
then they can be enrolled into the study and given the drug.
This is a very special process.
You have to meet very rigorous criteria before the FDA will allow it to occur.
An example--and why traumatic brain injury fits--is that there has to be no really good
alternative therapy--which in traumatic brain injury, there is none.
It has to be a devastating disease or one that is life-threatening,
and of course traumatic brain injury meets that criterion.
There a number of other things that you have to meet.
Then you have to go about doing community consultation before the study starts.
You go out and gather up members of the community,
and you talk to them about this trial happening in their community--
get suggestions from them, provide them information,
see if they're for or against the study.
And by the way, for Protect over 85 to 90% of the people agreed that
this was a good thing to do in the community.
And then we also have to do--at the end of the trial--something called public disclosure
in which we have to release the information to the public
and really try to get it out there--what the results of the study were.
Those are just some of the requirements of the FDA's EFIC process.
Produced by Victoria Tilney McDonough, Ashley Gilleland, Justin Rhodes, and Erica Queen, BrainLine.
David Wright, MD, FACEP is a tenured associate professor in the Department of Emergency Medicine at Emory University, and the director of the division of Emergency Neurosciences. The Emergency Neurosciences program is dedicated to finding novel therapies for the treatment of rapidly evolving neurological conditions, including traumatic brain injury, stroke, status epilepticus, spinal cord injury and others.
The contents of Brainline (the “Web Site”), such as text, graphics, images, information obtained from the Web Site’s licensors and/or consultants, and other material contained on the Web Site (collectively, the “Content”) are for informational purposes only. The Content is not intended to be a substitute for medical, legal, or other professional advice, diagnosis, or treatment.
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