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  • 1.  Phase III study questions

    Posted 15-Nov-2023 14:42

    Team, 

    In a hypothetical situation where the phase III interim results are not showing better than standard efficacy, what options are there? 



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    Bani Tchekanova
    Escondido CA
    United States
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  • 2.  RE: Phase III study questions

    Posted 15-Nov-2023 21:02
    Edited by Narayan Rao 15-Nov-2023 21:02

    Your Data monitoring board would/should recommend options! The options depend on the data, indication, population etc! I think this would be a wrong forum to seek info on such an important topic!



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    GRSAOnline
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    Original Message


  • 3.  RE: Phase III study questions

    Posted 16-Nov-2023 10:43

    These sort of issues are faced everyday by the regulatory leaders. Thanks. 



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    Bani Tchekanova
    Escondido CA
    United States
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    Original Message


  • 4.  RE: Phase III study questions

    This message was posted by a user wishing to remain anonymous
    Posted 16-Nov-2023 14:56
    This message was posted by a user wishing to remain anonymous

    Agree with poster to consult DSMB. Typically, options are terminate study or increase enrollment #'s if statistics supports.


    Original Message


  • 5.  RE: Phase III study questions

    Posted 16-Nov-2023 08:50

    Hypothetically, your statistical analysis plan that justified doing an interim analysis would also outline what steps you would take if the interim results demonstrated futility. If you don't have a plan for the interim analysis that is supported statistically, you have a problem that is not likely to be solved easily.



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    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    Burien WA
    United States
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    Original Message


  • 6.  RE: Phase III study questions

    Posted 16-Nov-2023 10:43

    Thank you



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    Bani Tchekanova
    Escondido CA
    United States
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    Original Message


  • 7.  RE: Phase III study questions

    This message was posted by a user wishing to remain anonymous
    Posted 16-Nov-2023 14:55
    This message was posted by a user wishing to remain anonymous

    Sounds like something to discuss first with the scientific team and then with the business team.

    Do we understand why the results are not what we expected or what we hoped for?

    If it still seems a promising product, the options might be the same as before the team started down this path... Pursue it as an equivalent alternative to the standard;  consider if it may be superior for certain segments of the population;  consider if it may be a suitable adjunct to other products;  consider if it may be suitable for other indications;  consider if a different version of it might be more effective;  etc

    Then it's ROI vs educated guesses.


    Original Message


  • 8.  RE: Phase III study questions

    Posted 22-Nov-2023 05:23

    Hello Beni,

    It is a very limited information for us to be able to advise you but at the same time I understand that you cannot disclose due to confidentiality. 

    I have worked on many oncology studies and can share some experience from them that may be useful to you as an idea. I had a few studies through the years that did not meet the primary end point of progression free survival but patients had an extended overall survival so while the study 'failed' it actually showed long term benefit for the patients. In such case the company may decide to further look into long term survival data and potentially design another study. However, all this depends on the company and what their plans are. I had a very interesting case from few years ago where the study did not meet the primary end point but 5 years later when we were closing the study the patients were cancer free. I think it was an amazing result for the patients and yet the company decided to stop the development of the drug.

    In short, it is a complex decision which depends on the drug, patient population and what the company can afford to do at this moment. 

    Good luck with your study.

    Olga



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    Olga Peycheva
    Regulatory and Study Start Up Specialist (Clinical trials)
    Solutions OP Ltd
    https://solutionsop.co.uk/
    United Kingdom
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    Original Message


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