Re: Blinded studies

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Ray Koopman wrote:
> Somewhere on the internet several years ago, in the context of a
discussion of research ethics, I read an account of someone shutting
down the study he was conducting because he happened to speak briefly
in an airport boarding area with someone, and in the course of the
conversation discovered that the person was on the committee that was
monitoring his study. That's my recollection, but I haven't been able
to find what I think I read. Do you (or anyone else) remember anything
like that?

Hi Ray,

I do not recall that specific situation.

On the surface, I would have to believe that a more significant ethical breach occurred in the course of the discussion to result in the decision to terminate the study. For example, the actual discussion of interim study results or a pending material decision by the DSMB that might affect the conduct of the study.

To terminate a study solely based upon the awareness of the other physician's presence on the DSMB would not make sense to me, especially if this were a multi-center study that was well under way.

I sit on about half a dozen DSMB's at the moment. In each case, I have signed non-disclosure agreements, which not only cover proprietary information about the sponsors and the studies, but also preclude me from acknowledging that I am on a specific DSMB to anyone actively involved in the conduct of the relevant study without the explicit concurrence of the sponsor.

The agreements also document that I am not actively involved in the conduct of the studies (or other studies or DSMBs involving similar, potentially competing products), that I am not employed by the sponsor, that I hold no fiduciary relationship with the sponsor (ie. stock, stock options, etc.) and what I am compensated for my participation on the DSMB.

The physicians on the DSMBs, who are subject matter experts relevant to each study, have signed similar agreements.

This process is intended of course, to protect against the disclosure of proprietary information, including study results and to document the potential for conflicts of interest.

It is also designed to minimize the likelihood of inappropriate influence on the members of the DSMB by investigators and others involved in the conduct of the study.

If it were to become known by an investigator, that I was on the relevant DSMB, by my own doing or by the actions of another, the more likely scenario is that I would be asked to resign from the relevant DSMB and someone else would take my place. If it were by my own action, I would voluntarily tender my resignation.

Importantly, the non-disclosure parts of my agreements would survive such a change in status.

The same would be the case for the physicians.

I would not envision that any of the studies that I am involved with at present, would be terminated simply due to the disclosure of my role or that of any of the physicians.

If you should locate the article or document, I would be curious to see it.

HTH,

Marc
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