World cardiology leaders call for action to reinvent randomized clinical trials
medicalxpress.com
medicalxpress.com
I have found one huge missing component after clinical trials are complete. Literally, nobody really cares about adverse reactions. FDA "pretends".
Too much money in pharmaceuticals.
I had a severe reaction to a drug. Took me years of doctors, gaslighting, denial until I found a physician to perform tests I asked for, which confirmed damage to small nerve fibers.
I have read hundreds of research papers. Talked to many physicians. The information is now on the drug label, still I hear "that drug can't do that" quite often. At that point I have nothing to discuss.
Governments should be tracking ALL MEDICAL records. Looking for patterns. Some drug reactions are slow.
There is also another side of this, WinSanTor is trying to bring a drug to the market that uses pirenzepine. It can regrow nerve fibers. I talked to a researcher who took the drug orally and his skin punch biopsy for small nerve fibers improved and he went into remission. The drug is available in Japan and widely used with a low risk profile. I might take it myself, but would prefer to use the cream made by WinSanTor, they are struggling with funding and are in phase 3 trials. Last time I read they estimated they need 100 million to bring it to market.
It's possible to conduct clinical trials that are not randomized in two branches. For example cohort study and the case-control study.
It's also possible to make more human clinical trials that are randomized in more than two branches, see for example the Healey platform [0]. In this case patients have access to several drugs drugs, with one being a placebo. So there is no "Russian roulette" effect where one patient can be enrolled in the control group and die, while a drug could have save him.
Clinical trials now also enroll women (they did not until recently because women could be pregnant) and persons of color and more diverse ethnicity. Until recently drugs were designed for men exclusively even if women have specific symptoms and pathology ... including in heart diseases.
Apparently cardiologists do not like these other kind of clinical trials, but they do not like either the heavy formalism of randomized, double-blind, and placebo-controlled clinical trials.
"Only essential data were to be collected and, wherever possible, much of the follow-up information was derived from national electronic health records (EHRs)"
Actually in real life there a wide chiasm between the trial protocol and the way patients are treated. There are many horrors stories with at least:
- Patients that are "channeled" by a whole industry that exists only for that purpose
- Trials that are conducted by busy CRO which try to streamline costs as much as possible.
There was an excellent post a few weeks ago on this topic.
[0] https://www.massgeneral.org/neurology/als/research/platform-...
It reminds me Andy Grove clinical trial proposal [0]
In short, if it doesn't kill patients in a small phase I trial, give market authorization. Then follow patients through EHRs for a few years, and if too much of them die then revoke marketing authorization.
Derek Lowe writings on the subject are, as always, very interesting [1].
[0] https://www.science.org/doi/full/10.1126/science.1212118
[1] https://www.science.org/content/blog-post/reaction-andy-grov...