This is where I have no expertise. The actual variables of disease changes the approach to when to use Phase III trials.
Meaning we live in an age of chronic disease treatments. We are in a middle land where many people have “less” suffering with good drugs.
We live in a time of stories of better drugs. That generally is not the case. That is what is dangerous about taking new drugs prior to their being well used with limit side effects for at least five years on the market.
Doctors have a very strict need to manage prescriptions. For whatever individual reasons many doctors are not nearly as strict as they need to be.
The phase three part of this discussion is the zone between being on the market and still being in trials. It is making less difference now in many many cases.
Interesting (maybe) anecdote for you David. My husband credits Koop, Anthony Fauci and ACT-UP with accelerating the development of a good many anti virals and not just for HIV. His primary research over the past decades has been HBV and HCV but here’s a preliminary paper on one little bit of the HIV puzzle
As is oftentimes the case, a sideshoot line of research that began in the mid 80s and pretty early days in the AIDS epidemic when hospital wards were actually filled with dying patients. One of his GI cronies happened to mention in a throwaway remark over a cup of coffee that he’d see the second patient in a short time whose ulcer disease disappeared when he developed AIDS. “Now that’s peculiar” thought dh (probably the most exciting 3 words in science) then came "I wonder if… (the second 3) See, back in England, he’d done some consultancy work with drug development for Janssen pharmaceuticals.
A lot of their products were actually nicknamed “rocks” in Flemish as they were notorious for needing a very acid environment for dissociation and absorption. One such was ketoconazole…a pretty powerful anti fungal. Usually. You’ll probably remember that one real misery inducing manifestation of AIDS was a horrible candida infection…quite literally mouth to the other end (TMF won’t let me use the real word) that was thought to be a resistant strain until this. A few subsequent studies and a bit more work identified AIDS gastropathy (dh coined the term) One puzzle piece in the Big Picture. Wouldn’t have been a long lasting line of research, mind, as HAART came along and you know the rest.
Thanks for that anecdotal good news story from that long ago era. I remember doing death bed counseling with two guys who had both suffered so horribly from candidiasis that they affirmatively wanted to die despite otherwise doing OK on opportunistic infections. Good on your dh and god bless those two sets of three words!