if someone is a collaborator on another trial, on whcih i am also a collaborator, adn at the same site as my trial - does this preclude that person from membership on the DSMB of my trial??

Thanks!

Reply

  • aawasthi amina awasthi Sept. 20, 2011

    Hello Sharon. Can you explain a bit more? are both trials at the same site? I should think it depends on the trial design and if there is any possibility that the blind could be broken and released to you, even by accident. Please can you tell us the following. A bit more about the trial, who else is on the DSMB and where there trials are. Then I am sure several people will have a view on this

  • sharonecox Sharon Cox Sept. 21, 2011

    Hi, Both trials are within a cohort of patients with sickle cell disease in tanzania, that my collegue and I are responsible for. My trial is due to start early next year and is a DBRCT. The second trial on which my colleague is the PI wont start till end of 2012 or 2013 - but mine will not have finished by then. The trials are testing differnt interventions on different outcomes in differnet populations from the cohort. Hers is not randomised or blinded. I am listed as a collaborator on her grant application. The person i had in mind for my DSMB is also a collaborator on my collegues trial - because he has expertise of clinical trials in sickle and therefore he would be ideal for my DSMB as tehre are few people wiht this expertise.

    What do you think??

  • brianfaragher Brian Faragher Sept. 23, 2011

    Dear Sharon

    For me, the most important role of a DSMB is monitoring serious adverse events as and when they arise - and for the DSMB to be able to react quickly and, most importantly, independently of the researchers (particularly the PI) if a serious safety concern arises. Any conflict of interest among DSMB members would obviously compromise this role.

    The person you describe appears to have the (probably rare) level of knowledge essential for your DSMB with the added advantage of being local to the trial site, so in a position to be consulted quickly and easily should the need arise. It is common in my experience for researchers working in the same clinical area in close geographical proximity to share DSMB duties between themselves.

    Being a medical statistician, as there are few of us around, particularly in the tropical medicine field, the cry of "I will be on your DSMB if you will be on mine" is commonly heard - and I am unaware of any major problems caused by this sharing of responsibilities.

    Conflict of interest could arise if DSMB members find themselves applying in competition with each other to funding body calls, but at worst this would simply require the individuals to resign from their respective DSMBs should the problem arise. Clearly, conflict of interest should be regularly monitored.

    However, if you are convinced that the person you have in mind can offer disinterested (for me a better criterion than "independent" in this context) expert advice on your DSMB, I see no problem.

    Brian Faragher
    Liverpool School of Tropical Medicine

  • sharonecox Sharon Cox Sept. 23, 2011

    Thanks very much Brian for the input. Very usful to get opinions like this.

  • Chilengiroma Roma Chilengi Sept. 26, 2011

    Dear Sharon,

    Please allow me to add to this discussion as the operations of DSMBs is an area of interest to me.

    According to Wikipedia, "a conflict of interest (COI) occurs when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other.
    A conflict of interest can only exist if a person or testimony is entrusted with some impartiality; a modicum of trust is necessary to create it. The presence of a conflict of interest is independent from the execution of impropriety. Therefore, a conflict of interest can be discovered and voluntarily defused before any corruption occurs"

    With this in mind, i very much agree with Brian's view. From my limited experience, it is particularly hard to find the appropriate expertise for DSMBs particularly in the African setting. While we must do our best to identify and avoid COI, we should also recognize that it is more important to get that relevant expertise to make an effective DSMB.
    Nonetheless, my view is also that in your particular situation, where from my understanding of the background you may be listed as "collaborator", the element of your "independence" poses a risk of your impartiality in judgement. I do not have sufficient background here to push this argument, but i would thus suggest some careful attention to be paid to this; if there were available alternative potential members, it would probably be best you provide support as collaborator. But if there is scarcity of experienced potential members, then you could in my view still serve as a DSMB member who should make the existing association known to the relevant stakeholders.
    Best regards,

    Roma

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