Wednesday, December 3, 2014

The Ethics Of The Coming Head To Head Ebola Vaccine Candidates Trial: NYT's "Room For Debate"

The ethics of running clinical trials are complicated where -- as here -- there is a real probablity that the vaccine will work, and more than a few people will die, if given only a placebo. This is likely a primary factor driving the January 2015 head-to-head clinical trial protocols. It is likely that the first 100 or so patients will be randomized into either the GSK or the Merck vaccine candidate inoculation.

If, at a few weeks, both show strong immunity (while others in Sierra Leone continue to perish, in the same community, untreated), then there will be no need for a placebo arm. And if the GSK vaccine is less powerful, and durable than Merck's, all futue patients will receive. . . that's right, Merck's vaccine candidate. But we shall see.

[And separately, I'll note that our 44th President is dedicating new resources to both the vaccine effort for, and triage/treatment of the ebola patients, worldwide. It is -- of course -- the right thing to do. Kudos!]

Back to the central topic then -- here's the "Room for Debate" item, in the Gray Lady -- which set me to thinking about all of this, and a bit:

. . . .is it ethical for the drugs to be given in randomized, controlled trials — considered the gold standard in methodology — since that would require some patients to take placebos?

In West Africa, for example, the first 40 Ebola patients in a trial could all get an experimental treatment, and nobody would take a placebo. If nearly all patients survived, in settings where most others were dying with the same supportive care, then it is possible that placebo testing could be avoided, and subsequent trials could randomize to different doses or treatments. . . .

Be excellent to one another out there, today. Be nicer than you. . . really need. . . to be.

1 comment:

Birdman said...

I am surprised that you are not getting any comments to your posts.

STEPPED WEDGE DESIGN for ebola vaccine field studies!!

I have not heard all the arguments by the USG for pushing the Randomized controlled Trials (RCT).

The FDA has recently published their reasoning for performing RCT for ebola therapeutics

Cox, E., Borio, L., Temple, R., 2014. Evaluating Ebola Therapies - The Case for RCTs. N. Engl. J. Med. doi:10.1056/NEJMp1414145

and there were significant debates over the vaccine Phase 3 stuudy designs at the WHO ebola meeting at the end of September.

This is quite the ethical quagmire.