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About ClinicalTrialPatient.org

Advocating patient centricity as the driver of better innovation and outcomes; for utilizing AI with the broadest array of patient data and patient reported outcomes in clinical trial design and aftermarket regulation. I’m passionate about innovation. I've had the opportunity to test drive two experimental medical devices. Both very different devices; an artificial spinal disc and an inferior vena cava filter. Both failed. Both failures were life threatening. Both failures caused a lifetime of injury and pain. Both experiences were unnecessary had the manufacturers, FDA, and Congress prioritized patient welfare Selecting what data points to study and which to ignore is historically dictated by the pharmaceutical company and the FDA. In my experience this can lead to all kind of problems, as well as missed opportunities In one instance, it was a miracle to survive when the unexpected and unimaginable happened during a clinical trial for an artificial spinal disc. Post-trauma, with life altering injuries, I learned to walk again (twice), had to find new ways of living and new paths to peace, joy and health in what had become an unfamiliar world Now, I’m an advocate for patient centricity as THE driver of better innovation and outcomes; for utilizing AI with the broadest array of patient data and patient reported outcomes in clinical trial design and aftermarket regulation. With AI, the data itself dictates what data points are relevant or important, what overlooked data points or patterns may present an opportunity. It’s the broadest array of historical, contemporary, and comparative patient data that tells us if a product is safe and effective as claimed. My experience informs industry conversations in - clinical trial, statistical & data design - post market approval data - patient reported outcomes - FDA post-approval systems & oversight - the Hypocratic Oath - & more

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