Re: [visionlist] [cvnet] Re: Proposed clinical trials definition

Hi Ben,

I like your idea that the special status for clinical trials guarantees additional safeguards were in place, and the implication that such a higher bar need not be met by all studies, but instead adds greater weight to those studies that meet that higher bar.



On Wed, Jun 7, 2017 at 6:12 PM, Ben Backus wrote:

Hi all,

Let’s make sure this keeps moving.

1. Jeremy is right. YES, we all really do need to write to the NIH.
Please do it today if you haven’t yet, even if you don’t currently have
funding from the NIH. Again, Jeremy and Nancy’s suggestion was to write
to William Riley, NIH OBSSR, If it won’t slow you down, include other contacts.

2. I am conducting a clinical trial (Project LUMA). It
is appropriately classified as a clinical trial. Clinical trials come
with a large administrative and regulatory burden. So I can assure you
from personal experience: if your work
gets redefined to be a clinical trial, your work day will look very
different, much more like that of a hospital administrator and much less
like that of a scientist.

3. Please seriously consider whether you should stop
doing any clinically related research until this issue is resolved by
NIH. If you or your students want to help people with visual disorders
of any sort, you might want to *not* do
that project right now. I would, at a minimum, get assurance from your
local university/college administration that they will not enforce the
new rules against you. It’s difficult for any administration to not
comply with NIH guidelines. T35 summer projects
for students may be at special risk here. We may need an emergency
ruling from the NIH that these small summer projects can proceed in the
current year pending resolution of this issue.

4. I don’t think the actual issue is whether the research is
clinical or not (i.e. a health-related outcome for safety and/or efficacy).
What we need is an optional category, available to drug and device
manufacturers (and to any researcher) that observes
additional requirements, and results in additional certifications for
the study results. If you do a “certified clinical trial” then your data
handling has received heightened scrutiny, and your subjects have
received heightened protections, so that your study
carries additional weight, as should be necessary for FDA approvals. In
other words: the NIH should not try to define what a clinical trial is and then
require all such work to follow guidelines. Instead, the NIH should
spell out what the special requirements are for those
who want to do a certified clinical trial, and the FDA can require
this, and publications can require that authors report whether their
study was a certified clinical trial or not.

Thank you Jeremy and Nancy for raising the alarm. Thanks also to the VSS Board for their quick response.



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