PNV (ASX) PNV Media Thread

Originally posted by Ivans51: ↑

I find it interesting and disturbing that periodically posters find new ways to attack PNV / BTM; this when the previously used method has started to run out of steam. Generally the attacks are undertaken by newbies and they occur at times of possible inflection points in the SP.

so the current one seems to be based on the lack of clinical trials.....
I suspect this lack of gold standard clinical trials has also been used to allow "analysts" to make the most outrageous statements concerning infection rates when a synthetic or a biological material is used in burn care.

firstly, as a quick rebuttal, I suspect that many of the posters on the PNV threads do know a lot, both about medicine in general and scientific trials in particular.

the current newbie seems to be confounding what can (easily, if expensively) be done in a drug trial to what simply can not be done when evaluating a new surgical procedure. Put simply surgical RCTs cannot fulfill many of the important quality traits of the ideal standard RCT.

First, timing and planning of surgical RCTs are difficult since surgical methods evolve gradually over time and too early rigorous assessments may be unfair to the evolving methods which few surgeons yet master while clinical equipoise may be lost if evaluations are done too late.
Also, standardization of interventions may be difficult as surgeons are trained differently, improvise, and may develop their surgical technique over time.
Also, perioperative care and surveillance are often different between different departments and may be tailored in given patients.

Surgical RCTs are usually not done in stages and choosing the most appropriate endpoints and estimations about effect sizes and statistical power can therefore be difficult.

Recruitment may be problematic. Patients are often more reluctant towards invasive, risky, and non-reversible interventions if the treating physician has no clear treatment recommendation.

Operative treatments are usually not as common as drug treatments, and this affects recruitment, market value, and funding opportunities.

Perhaps the most important weakness associated with surgical trials is difficulty with blinding. the surgeon can usually not be blinded and sham-controlled interventions are seldom feasible.Furthermore difference in follow-up routines or surveillance between the two treatment arms is not uncommon if comparing completely different treatment modalities.

Due to the aforementioned points, surgical RCTs usually cannot fulfill many of the important quality traits of the ideal and gold standard RCT.
According to the Oxford Center for Evidence Based Medicine, the obtainable level of evidence from a poor quality RCT is not better than a well-conducted cohort study.

So what do surgeons do. They do their own case studies, they build up cohorts of these studies and they gradually spread the word and then (eventually) along comes someone with very big pockets (e.g. BARDA) and funds a multicentre, prospective cohort study.

And as I write all of this is happening.

Expand

I'm sure you know it, RCT's are the single best tool that a sales force can have to penetrate the market, especially a very conservative and well established one with a large ingrained STC supplier - integra.

BTM was approved in the US in 2016 via the FDA510k protocols (no RCT required) to fast track into the surgeons hands, would it have helped if they had entered via PMA (with RCT) to get it into surgeons hands faster? $7m/quarter after 5 years on the market is not breaking any world records, those surgeons might be keeping it to themselves.

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Last updated 15.59pm 03/05/2024 ?

PNV Media Thread, page-1761

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