I am writing to see what others think about reporting adverse events and how this is done in other areas. We report every serious adverse event to all our ethic committees and to our sponsors. This is for a trial running in three countries in East Africa with a European sponsor. As we had several committees review our protocols this is quite a lot of reports, paper and time. We file every letter and track the replies. I understand that in other areas, it is Europe? They only report the probably related serious events that were unexpected - can someone tell me if that is correct? This does seem a better idea. Our committee receive a copy within 24 hours of every SAE. How can they follow these and act upon them? Surely this is taking up time for these committees when they are already over-stretched? What do they do with these reports? It is not possible for them to be monitoring them rigorously and spot anything important as this would require detailed analysis? It must be better to send only the unexpected event in this 24 hour window. If we did this then the important events are clear and not lost amongst all the RTA's and children falling from trees? Can we help our committees and change this system in East Africa and perhaps elsewhere?

Reply

  • jjaimemiranda J. Jaime Miranda 8 Sep 2010

    Here is another example of why we need to move to "interconnection" between ethics committees. Like with grant applications to receive funding (one institution deals with the funder and "divides" or allocates the agreed research funds to their partners), one ethic committee should be the prime to deal with most of the issues arising from the trial. There should be agreements so that multiple committees would respect the decision / processes of a single "main" one.

  • Dear Moses,

    in a similar situation, we firstly ask each EC if they want to receive the SAEs on a case-by-case basis, or as aggregate data (e.g., on a quarterly basis). Still, the big majority of ECs, especially in the host countries, usually confirm that they prefer to receive the SAEs on a case-by-case basis.

    However, the ECs are not the only counterpart with which we share safety data on SAEs (for instance, there is also the independent DSMB, and the drug's manufacturers). Thus, we need (a)to standardize the information (and schedule) for each relevant counterpart, (b) to answer to comments and queries of the different counterparts, and (c) to streamline the answers to all of them.

    In general, accurate SAE reporting is crucial for a better protection of the study subjects, and both Sponsor and Investigators should put a lot of effort on it. However, the current regulations and guidelines do not distinguish among the different kind of trials: if a risk-based approach was adopted (e.g., fast track SAEs reporting for registrative studies, for studies with vulnerable groups etc.; and periodical aggregated updates for phase IV studies...), the ECs and the other counterparts could probably better focus their energies to timely assess safety in studies with a higher degree of risk.

    Something to be considered when the current GCP Guidelines will be revised? .....

  • phaikyeongcheah Phaik Yeong Cheah 21 Sep 2010

    Dear Moses,
    Indeed, ECs in the EU only look at related and unexpected SAEs as per GCP. I am based in Thailand and the Thai ECs want to see individual SAEs. I agree with you and do not think this is a good idea as important safety information will get lost.
    Periodic reporting (listing) is a more efficient way.
    Phaik Yeong

  • Dears,

    to my knowledge the European Directive still requests that "the investigator shall report all serious adverse events immediately to the sponsor except for those that the protocol or investigator's brochure identifies as not requiring immediate
    reporting. The immediate report shall be followed by detailed, written reports".

    For SUSARS (Suspected Unexpected Serious Adverse Reactions), on the other side, an especially fast track reporting is requested. The standards for reporting SUSARs are defined in ‘Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical
    trials on medicinal products for human use’ and are consistent with ICH E2A, and with the application of ICH-E2BM (CPMP/ICH/287/95 as modified) and ICH-M2-E2BM
    (CPMP/ICH/285/95 as modified) to clinical trial SUSAR reporting.

    Raffaella

  • VivatThomas_Njie Vivat Thomas-Njie 4 Oct 2010

    Dear Moses,
    In the Gambia our unit has a SOP on AEs reporting which we follow and it clearly states that the PI must report any AE assessed as SAE as stipulated in the study protocol and should include the sponsor, and if applicable the local safety monitor and the DSMB, only Unexpecetd Serious Adverse Event that are assessed as related to the IP or study procedure must also be reported to the local Ethics Committee immediately.
    I believe having a SOP on this may help clarify the procedure if not requested in the study protocol.
    Vivat

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