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  • 1.  Negotiation times for Clinical Trial Agreements

    This message was posted by a user wishing to remain anonymous
    Posted 01-May-2020 14:09
    This message was posted by a user wishing to remain anonymous

    ​Dear community,

    I would appreciate your insight: If we are talking about sponsor initiated pre-market, post-market trials or registries for medical devices:
    How long would you estimate does the negotiation of a Clinical Trial Agreement (CTA) between a site and a sponsor take in average (from the first time a draft is sent to the site to the final signature)?
    Does the processing time vary by country? Are there countries, which are quicker and slower?
    Does the time vary based on the template (country specific template, hospital template, site template)?
    Does the time vary based on the type of the trial?
    Do you have positive experiences with MCTAs vs single study agreements?

    Thank you very much for your support!

  • 2.  RE: Negotiation times for Clinical Trial Agreements

    Posted 02-May-2020 03:09
    Dear sender,

    Executing CTA is actually a bottleneck for site activation in majority of European countries, as national/regional legal framework is an obstacle for successful utilisation of trial contract template, especially since largest sites are usually government hospitals, hence less flexible during negotiation process vs private sector hospitals.

    Negotiation process can vary from 1 - 6+ months. As such information on contract negotiation process should be discussed with investigators prior to site selection. Even at feasibility stage many sites are flagged for protracted contract negotiation.

    To prevent this country templates are usually developed based on incorporating local inputs in study template, which is then distributed to sites for comments, as sending study template without prior customization would lead to higher number of comments by local lawyers, which impacts execution timeline.

    In addition, some site will request individual agreements between the sponsor and site staff or departments, so the total number of signed agreements can be number of sites multiplied by 1 - 10+ depending on the site and study complexity.

    I'd say MCTA works well in the US, even for some large sites, but difficult to apply to nonUS sites (especially those that can deliver).

    As this is a bottleneck in study startup phase, CROs usually have dedicated departments that deal with CTAs, create study level plans for contract&budget negotiation and execution prior to trial application, where strategy and timelines are described in details to address this topic.

    Hope this helps.

    Kind regards,

    Vladimir Vujovic
    Regulatory and Safety Manager