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

[Lester Loschky]

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.

Best,

Les

On Wed, Jun 7, 2017 at 6:12 PM, Ben Backus <ben.backus at gmail.com> 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, william.riley at nih.gov. 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.
>
> Ben
>
> --
> Benjamin T. Backus, Ph.D.
> Associate Professor
> Graduate Center for Vision Research
> SUNY College of Optometry / SUNY Eye Institute
> 33 West 42nd St.
> New York, NY 10036
> bbackus at sunyopt.edu
> Tel. +1-212-938-1541 <(212)%20938-1541>
> Fax +1-212-938-5760 <(212)%20938-5760>
> http://www.projectluma.org
> <http://sunyopt.edu/research/backus>http://poseidon.sunyopt.edu/Backuslab/
>
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>
>


-- 
Lester Loschky
Associate Professor
Department of Psychological Sciences
471 Bluemont Hall
1114 Mid-Campus Dr North
Kansas State University
Manhattan, KS 66056-5302
Phone: 785-532-6882
E-mail: loschky at ksu.edu
research page: http://www.k-state.edu/psych/research/loschkylester.html
Lab page: www.k-state.edu/psych/vcl/
<http://www.k-state.edu/psych/vcl/index.html>
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