Oh how so I disagree. I think the medical establishment in western civilization is a shame. Why does the peer review process need to take so long? Seems like a very arbitrary time frame anyway. Is it because of a lack of resources? That's pitiful.
On what point do you disagree?
Being a tinnitus sufferer now, AND being in the medical device world for a long time, I don't care for long waits and peer review either. However, data validation needs to occur before submission for approval depending on the avenue you are pursuing.
In the implantable device world, you needed that peer review to get the IDE (Investigational Device Exemption) from the FDA to proceed with writing the trial and submitting the protocol for approval. I'm not sure where they are in that process, and I am not familiar with how CE mark is granted.
I'm also not familiar with how their field of medicine works in the submission process. They all generally follow a similar protocol, but yes, resources ($) could come into play. Respected journals do expect their authors to be compensated, but honestly, in my experience it wasn't that much. I had clients do peer review on journal submissions to JACC for as little as $5K. Certainly won't break the bank of even a small biotech company. Again, I can only speculate and not speak from any experience in this particular field.
The reason you need data validation, whether you are in the Western hemisphere or anywhere else, is to avoid the very thing that plagues tinnitus sufferers right now; un-validated, sham, gimmicks, and treatments. I don't see the fault in that.
Some of the difficulty here is the subjective nature of the disease. The more subjective the measure, the more difficulty in quantifying your primary endpoints. How is volume of tinnitus quantified from something that really isn't a sound? This, I'm sure, plagues study authors and researchers. So, they are left with, again, subjective surveys and questionnaires. They are getting better, but they are very analogous to QOL surveys with cardiac patients. Sometimes they were helpful in attaining the primary endpoints, sometimes they were not.
Anyway, we all want the same thing; a valid device, drug, therapy, etc. that will help us suffer less, and hopefully stop us from suffering entirely.
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