How clinical research is coming home.
Thoughts on being close to our patients
Meet your patients how and where they are
In this essay, I take a closer look how clinical trials are changing.
We’ll see how the pandemic, innovation in clinical operations models and how consumer technology each play a part in a rapidly-evolving, increasingly patient-centric clinical trial supply chain.
Change happens — just not how you expect
The classical supply chain model for clinical trials where sponsors went to CROs who went to sites who recruited patients is now changing.
The first driver was the pandemic.
Virtual nursing, remote nursing and Telehealth providers grew and developed rapidly during the pandemic. The adoption of remote and virtual care spilled over from primary care to clinical trials. Patients no longer need to leave home and nurses can come directly to the patients’ homes to test and monitor the patient.
The second driver are new operational models.
There are now new operational models for delivering clinical trials to patients. This is in contrast to current models of bringing patients to sites to investigators to CRO to sponsors. PharmaKon is one clinical research consultancy changing rules by changing their model of clinical operations.
Three nursing specialties are being used by PharmaKon to staff its clinical trials: virtual nurses, remote mobile nurses, and patient concierges. Virtual nurses work remotely through telemedicine portals and EDC systems with clinical trial data. Remote mobile nurses visit patient homes. Patient concierge nurses oversee daily patient calls and perform compliance checks via remote monitoring and/or phone calls. Sponsors are encouraged to design new study protocols for procedures such as labs, vector samples (stool, semen, saliva, urine), vital sign monitoring, EKGs, and health assessments to be completed remotely.
The third driver of change is a return to patient-centric
From Hippocrates to Maimonides, making the patient the focus of care was always the starting point for a physician. Somehow — the clinical trial industry lost its way and started referring to patients as subjects not people.
It’s easy to think that this might be just a question of semantics.
But its not just semantics.
We are all adapting to a pandemic environment.
We grapple with a reality of heavy traffic jams and are deterred by public transportation and being exposed to the latest Covid variant.
We live in a time where entire populations are under-represented in clinical research. To a large degree, diversity is a function of accessibility. People with money can afford transportation and smart phones for the latest in decentralized trials technology used by a sponsor. But people who are poor, people to whom $50 is a lot of money, are disenfranchised to advanced therapeutics and DCT.
Our patients not be able to use a mobile ePRO because it’s in a language they cannot read and runs on a devices they don’t own.
These are challenges that Hippocrates and Maimonides did not deal with.
OK, so not everyone is a generation Y living on the West Coast
Consumer technology used in digital health can be applied in clinical trials to meet patients where they are and tackle these challenges if we patient-centric design and not patient-centric lip-service.
Let’s take a look at one technology that enables life science companies to meet patients where they are: digital therapeutics.
Digital therapeutics are mobile apps that complement or replace drugs.
When combined with a validated, connected device — digital therapeutics enable us to get right onto (or into) the patients’ bodies — during the clinical trial and passively collect accurate and timely clinical data.
Today, chronic disease patients in areas of gastro, pain and oncology are being monitored by investigators and site coordinators using digital therapeutics in clinical trials running on the flaskdata.io cloud API platform.
Connected medical devices used for monitoring, can be monitored themselves and reprogrammed remotely in order to improve their effectiveness and assure consistently high levels of data quality.
This is a new era — the era of IoB — “The Internet of bodies”.and timely data.
In summary
We need to do patient-centric clinical research just as we need to do patient-centric medicine.
Tech, the pandemic and operational innovation help us get there.
Danny Lieberman is a solid-state physicist by training, serious amateur musician and tech entrepreneur. Involved in a cutting-edge project that harnesses AI to help us achieve transparency for our clinical data.
He is proud to be working with some very smart people, all smarter than him.
Originally published on the Flaskdata.io blog
