3 ways that assure protocol compliance and data integrity in your clinical trials

March 20, 2022

In this short essay,   I’ll take a closer look at how the clinical trial supply chain is evolving.  There is now rapid change from traditional site-centric trials to patient-centric operations that assure data integrity and safety monitoring

We’ll see how the pandemic, innovation in clinical operations models and consumer technology drive the change to patient-centric research.

Meet your patients how and where they are

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.  Changes to the drug and device clinical trials supply chain are being driven in 3 ways: by the pandemic, by changes to the operational model and by increased adoption of patient-centered care.

  1. 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.
  2. There are 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 The 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.
  3.  Patient-centric care is being improved by adoption of mobile and cloud technologies.   From Hippocrates to Maimonides, its clear that  centering focus around the patient is the starting point of care.But its not that simple.

    We are adapting to a pandemic environment.

    We cope with a reality of traffic jams, and 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.

    These are challenges that  Hippocrates and Maimonides did not have to deal with.

    Consumer technology used in digital health are now widely applied in clinical trials to meet patients where they are and tackle these challenges.

    Let’s take a look at one technology that enables to meet patients where they are: digital therapeutics.

    Digital therapeutics are treatments that complement or replace drugs. Digital therapeutics often use a combination of a mobile app and a connected medical devices.  Digital therapeutics include  applications of mobile software for  telemedicine, wearables, smart watches, cognitive behavioral therapy.

    When combined with a validated, connected wearable – 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

It goes without saying that we need to do patient-centric clinical research.

The pandemic pushed us to move faster. Consumer tech lets us move faster and new operational models enable us to get up close to our patients.

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