groups » Trial Management » End point review committees

It has be suggested to our team that we need an end point review committee. This is because we have severe adverse events as end points and it is a multicentre study. We have not set one up before it would be helpful to learn from others and i also like to know why they are good and important. End point review is something new to our center.

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end point review endpoints severe adverse events

  • hmendes H Mendes 3 Oct 2010

    It has be suggested to our team that we need an end point review committee. This is because we have severe adverse events as end points and it is a multicentre study. We have not set one up before it would be helpful to learn from others and i also like to know why they are good and important. End point review is something new to our center.

  • GHN_Editors The Editorial Team 5 Oct 2010

    There is an article on this topic within the guidelines which gives a brief summary. http://www.globalhealthtrials.org/articles/trial-oversight-committtees/

    However it would be excellent if some research groups could share their specific examples of using endpoint review.

  • The endpoint review committees (ERC) are necessary to adjudicate the events reported as endpoints from the different sites conducting the multicentre study. This committee is usually central (not site specific) and reviews all the clinical summaries of the events submitted (from all the sites). Needless to say, the committee is usually blinded to the randomization arm to guard against reviewer bias. This committee may be composed of Principal Investigators / project managers from the different sites, in addition to other people (It doesn’t need to be so big though). An important part also, is to have a monitor / quality assurance officer to review the clinical summaries against the CRFs and source documents to verify their accuracy, verifiability, consistency and completeness, preferably in real time, so that any identified discrepancies/issues can be addressed prior to the adjudication. Is yours the coordinating centre or just one of the sites conducting this study?

  • andyburke Andy Burke 7 Oct 2010

    As Remmy says central review of any clinical endpoints certainly helps to ensure consistency across sites/investigators. Clinical diagnoses are usually quite subjective, so you do get variation in reporting of severity and cause. Central review can end up being a lot of work though as you need to gather adequate clinical evidence centrally for review and (again as Remmy says) ideally carry out some site monitoring to assure the quality, completeness and accuracy of that evidence. It's best to start it early in a trial rather than leave it to the end so that you can get the systems sorted and ensure that the required documentation is being collected. Although the review should be blinded to treatment you should ideally have independant clinicians involved to avoid any possible perception of bias. You certainly would not just want the Chief Investigator doing all the reviews.

  • jthitiri JThitiri 14 Oct 2010

    I have had an experience of sort with this. I was involved in running a phase II safety trial in Kenya,in which safety was and endpoint. For this we had a "Safety Review Committee", whose main role was to review all our SAEs/ SUSARs and make a determination of causality. The committee consisted of 3 experts in areas of the study, who were all independent. The committee then worked together with our local safety monitor, also independent from the study, and this LSM eventually made a summary of each case/event for reporting to our local ERC, and sponsor institution's ERC. Our role as study team was to provide detailed event account, and supply further infor. to the SRC as required. This way, investigators were not involved in determination of study endpoint especially because the trial was not blinded. The committee was really helpful.

  • hperez hperez 15 Oct 2010

    Thank you for that useful example. I agree this is where endpoint review is important. If there are many centres in one trial we have issues with some investigators defining events differently. One might find a clinical event more or less serious than other or can diagnose differently. We cannot be sure of getting a realiable answer in our trials if in these situations there is not independant expert review

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