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Thread: Contract terms - SAE reporting to commercial funders when University is Sponsor

  1. #1
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    Exclamation Contract terms - SAE reporting to commercial funders when University is Sponsor

    Hi,

    As a non-commercial sponsor working with Industry we are increasing being asked, in contracts, to send all SAE reports to the commercial partner (who supplies IMP and/or finance) within 24 hours of awareness. In early phase studies (I &II) with unlicensed product this can seem reasonable. However in later phase studies with licensed products we are reluctant to agree to this as it does not seem to be proportionate to the risks involved and greatly increase the burden on us in reporting terms. In these later phase studies we often attempt to say we will report all adverse reactions within 24 hours and will send quarterly line listings of SAE - but increasingly it seems that this is not acceptable to commercial partners. Additionally, very often the protocol does not describe this and by the time these negotiations come to a head the protocol has already been REC / MHRA approved and we are unsure, if we agree to this, whether or not we then also need to amend the protocol. This is more work for everyone and tends ot delay the start-up.

    Does anyone know if there is specific legislation or guidance that commercial companies are following in this respect when they are not the study sponsor. I have asked but not had a satisfactory reply other than this is "company policy"!

    Any feedback or infromaion appreciated.

  2. #2
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    Hi,

    It is a common practice but I don't think it is mandated by legislation or guidance. The pharma company probably includes the safety data from a non-commercial sponsor in their PSURs and drug specific DSURs. They are also monitoring their licensed drug in a new indication or new drug combination.

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    The MAH may be developing the drug for other indications and may be responsible for preparing Investigator Brochures and DSURs. The risk benefit analysis may be altered according to information received and the MAH has a duty to inform other sponsors, investigators, ethics committee and regulatory authorities of any change in this. The safety picture of any compound does not just reply upon SUSAR reports. SAEs may alter the picture when combined with SUSARs/SAEs from other sponsors and with information in the MAH PV database. Hence they need to get information on SAEs in a timely manner. MAHs have invested a great deal in extensive PV systems. Consequently speed is very important if they want to get reporting into their system, test them, decide what needs reporting and be able to report them. Hence why they often have a "one size fits all" approach to timelines for getting reports into the system. You can negotiate terms in your contract with the MAH. However with regard to MAH reporting the MHRA has commented that:- "There is no requirement to send SUSARs to an MAH who is not the Sponsor (although the previous version of CT3 recommended this practice). It also follows that there is no requirement for MAH's to submit SUSARs from clinical trials to the MHRA, when they are not the Sponsor - this is the Sponsors responsibility. "

    MHRA comment: If the MAH is not the sponsor, but is providing funding and/or IMP then a contract will likely be in place and the MAH will want to get safety information reported and will specify a timeframe. If the Sponsor enters into this agreement then they need to follow the contract - and then the reasoning in the first part of the post stands.
    Last edited by MHRA Moderator; 20th Jul 2012 at 02:02 PM.

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    Relating to the 1st post on whether there is specific legislation or guidance that commercial companies are following when they are not the study sponsor:
    New (17 Jul 2012) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC states:
    Annual reporting by the sponsor to the marketing authorisation holder - Regarding authorised medicinal products which, according to the protocol, are used
    in accordance with the terms of the marketing authorisation, the sponsor shall inform annually the marketing authorisation holder of all suspected serious adverse
    reactions.

    I expect the MAH would still want copies of the SAEs (from non-commercial sponsors) as they occur but this is not specified in this proposed legislation (expected to come into effect in 2016).

  5. #5
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    MTS & a123456

    many thanks for the feedback - very useful information and reference. There does not seem to be a legislated imperative to report SAE to funders within 24 hours.
    It feels like, that as a sponsor we are within are right to negotiate the contract to a timeframe that is mutally acceptable and managable - it is then important to stick to that contract. I think we will now be more confident, especially with later phase studies with licensed products in saying no to reporting SAE to the funder in 24 hours, certianly as an initial position. For early phase studies or those with unlicensed product we may be within our rights to charge for this addtional activty if it becomes a condtion of funding.

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