Can you elaborate how you think COI affects this specific study?
@radiaterMike states as below.
These factors could consciously or 'subconsciously' impact trial design (as others mentioned, it was not a trial that could fail).
COI does not indicate mendacity or bad professional values. The whole concept is rooted in the fact that there are things that may affect our judgement and actions in ways that we
cannot consciously adjust for. COI is why jurists recuse themselves from certain cases and why admissions officers (or radonc chairs) should not assess their children's applications.
It would be a better look if Kishan did not have stock in VR. It does not mean that the research was not done honestly, just that there may be some "unconscious bias" by the researcher that is a result of financial interests.
I also would still like someone to point out how they think COI had a direct impact on design. Propose a mechanism. He has explained the choice of margins in control versus experimental arms and, as someone who has designed a few IITs, his explanation is extremely reasonable.
The explanation regarding margins is reasonable. It also means that there is no direct comparison between techniques because we have introduced a confounder (margin size). The margins are themselves pretty arbitrary and are rooted in "comfort levels". Fine but not very scientific. The important counterpoint to any toxicity outcome is cancer control, of course this trial will not answer if there is any meaningful impact on pCa control by reducing margins.
Regarding toxicity assessment? On 100 patients and including Grade 2 and low total numbers, the stats are not going to mean much to me. I have no idea if Kishan was personally involved in toxicity assessment or if there was a "vibe" given off to investigators who assigned toxicity, but all of these things can be impacted by unconscious bias. Is transient Grade 2 toxicity worth extra time and investment regarding treating prostate Ca? Well, we accept increased acute toxicity with every accelerated course anyway.
Most important regarding the COI issue is how this paper is used or quoted to support investment in VR. I recently saw a patient from a procure center and in their brochure they included short interval, retrospective 2nd malignancy data, which we all know represents differences the populations who receive protons and photons. If this paper becomes a meaningful part of the pro MRI linac movement, I think it is probably bad.
Now if an investigator knew what they going to publish and decided with that knowledge to buy a bunch of VR stock in late 2021, that would be bad and should be known. I have zero evidence that this was done.
I think the best way forward for RO is to encourage industry collaboration and be overly transparent with COI and accept that most of it is not inherently bad.
Industry needs to take the risk and needs to believe in their own product. IMO the proton story is one of docs wanting something to be better and knowing that they could establish value culturally from positions of high esteem when true clinical value of a technology was dubious in most cases. What should have been done with Protons is to have industry take the risk, build the centers and then have non-invested docs run the trials. When the trials were negative, industry should have been asked to regroup, come up with a better product or consider abandoning their initial investment.
I don't know if any given drug has ever had the impact on a MO department that something like protons has had on numerous RO departments.
How many MOs have stock in the companies that make the drugs that they are doing Phase II or Phase III trials on?
Disclosure: I do not know Kishan or Potters and never expect to meet them. I do not have Twitter. I have no stock in tech companies that is not bundled into my retirement portfolio. I do have a COI in that I want my relatively poor, community cancer center to remain competitive throughout the remainder of my career.