Jennifer Byrne has spent her whole career in clinical trials, working on more than 8000 studies. So she knows a thing or two about the needs of pharma sponsors, clinical sites and patients. As founder and CEO of Javara, Jennifer is spearheading a new concept: the integrated research organization or IRO, a novel model for bringing clinical research into the healthcare ecosystem.
In this episode of the HealthBiz podcast, Jennifer shares her journey –how it was influenced at various times by her father and her mother, and what she sees coming in the post-pandemic era.
Electronic clinical outcome assessment (eCOA) platforms collect data from patients, clinicians and caregivers to make clinical trials more efficient and accurate. iCardiac Technologies, an innovative core lab where I am a board member, just introduced its QPoint eCOA platform to complement its existing cardiac safety and respiratory function product lines.
In this podcast interview, iCardiac CEO Alex Zapesochny shares more about the launch.
(0:11) What are some of the key trends you are following in clinical drug development?
(1:04) You started with cardiac safety testing and then added pulmonary function testing. How do those fit together?
(3:00) Now you have a new platform, QPoint. What is it, and why is it the next logical service?
(4:44) For those who are less familiar with eCOA, what is it? And what are some of the challenges that are typically encountered?
(7:09) Compliance is often an issue with patient reported outcomes. Do you address compliance with QPoint?
(10:30) How important is eCOA for drug development? Is it a major change or incremental?
(12:20) You have explained the move from cardiac safety to respiratory to eCOA. What can we expect next from iCardiac?
In health information technology, there are no clinical trials or tests with randomized controls, as there are for drugs, for example. True, digital data does not go into the body, but it can increasingly guide what does.
Using vignettes of real cases and the SimulConsult diagnostic decision support software, neurologists listed a differential diagnosis and workup before and after using the decision support. Using the software, there was a significant reduction in error, up to 75% for diagnosis and 56% for workup. This error reduction occurred despite the baseline being one in which testers were allowed to use narrative resources and Web searching. A key factor that improved performance was taking enough time (>2 minutes) to enter clinical findings into the software accurately. Under these conditions and for instances in which the diagnoses changed based on using the software, diagnostic accuracy improved in 96% of instances. There was a 6% decrease in the number of workup items accompanied by a 34% increase in relevance. The authors conclude that decision support for a neurological diagnosis can reduce errors and save on unnecessary testing.
The government and healthcare providers are investing a fortune in health information technology. A lot of time, effort and cash has been spent on installing EHRs and getting the initial data into them. But the real clinical and financial value will come from using the information in electronic health records for better communication and clinical decision making.
The Times does readers a disservice by asserting that high quality clinical trials aren’t and can’t be done.