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Maya Zlatanova: Setting the clinical trial up for success by listening to the healthcare ecosystem
Manage episode 382347604 series 3526489
Treść dostarczona przez Sam Parnell & Ivanna Rosendal, Sam Parnell, and Ivanna Rosendal. Cała zawartość podcastów, w tym odcinki, grafika i opisy podcastów, jest przesyłana i udostępniana bezpośrednio przez Sam Parnell & Ivanna Rosendal, Sam Parnell, and Ivanna Rosendal lub jego partnera na platformie podcastów. Jeśli uważasz, że ktoś wykorzystuje Twoje dzieło chronione prawem autorskim bez Twojej zgody, możesz postępować zgodnie z procedurą opisaną tutaj https://pl.player.fm/legal.
We speak to Maya Zlatanova, the CEO and Founder of Trialhub and FindMeCure about trial strategy for clinical trials. We speak about the amount of information necessary to digest in order to answer the many complex questions during trial start-up, and how starting from the templates of previous trials can both be time-saving, but may also limit your perspective on what is possible with this specific trial.
By asking the question of “what can go wrong” can help open the innovative power of clinical trial design. This can also help the understanding of patients and sites in the real world, and lead to better decisions. This question can also lead to better empathy with the stakeholders, and help anticipate some of the issues that may arise in the trial based on the design.
Finding data that can reliably support the answer for this question is another challenge yet to be solved. This is complicated further by the collaboration between the CROs and sponsors, where the responsibility to collect the data necessary to support key decisions may fall between two chairs.
Aligning your clinical trial to the real world would ideally lead to adjustments of the clinical trial as it is ongoing - but that is prohibitively expensive and difficult. When you are having trouble recruiting patients for your trial though, it may be worth the cost to pivot your trial during conduct. Here patient listening may be a way to understand what else might be possible for your trial.
Patient recruitment slowing down may be a lagging indicator of trouble with your trial design. Having conversations with your investigators proactively can help you uncover potential issues with your trial before they manifest as recruitment problems. Understanding the entire ecosystem that the clinical trial takes place in can help you understand which alternatives to participating in a trial the patients may value more.
Guest:
Maya Zlatanova: https://www.linkedin.com/in/mayazlatanova/
Trialhub and FindMeCure: https://trialhub.findmecure.com/
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