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Siteless III: Impact and Lessons Learned to Date (Part 3 of 3)

August 8, 2018
Posted by: Gerald “Pharmacist Jerry” Finken, RPh, MS

Impact and Lessons Learned to Date

Of all the healthcare professionals, which one can you schedule a visit with or just walk into their office and receive free healthcare counseling, every time?  Only one: the pharmacist. For centuries, pharmacists have been counseling patients for free as part of their servant leadership role in healthcare.  Maybe, this is why the pharmacist has been the most trusted professional for decades—at least until the PBMs and insurance industry commoditized the practice of pharmacy, not realizing that the real value the pharmacist provides is their free counseling services.   This is one of the reasons why the siteless model focuses on the skills and professionalism of the pharmacist to bring about positive change and even industry disruption.

Siteless and Disruption

Change is not easy.  However, to bring about change, I always remind myself to follow the great advice of Dory, the lovable blue reef fish with the REALLY short memory in Pixar’s Finding Nemo animation. When confronted with a difficult challenge, Dory says, or in this case, sings:  “Just keep swimming”.

Those individuals who have brought about real change or disruption understand this all too well and if we do “keep swimming” we will then fully understand the quote by Mahatma Gandhi: “First they ignore you, then they laugh at you, then they fight you, then you win.”  Quoting Dory and Gandhi in the same sentence – unusual but pointed as both had good advice that we can all learn from and garner inspiration.

As human beings, we are wired to fear change, but in truth, as humans the need to fear change is no longer about life or death, it is more about being comfortable or uncomfortable.  In today’s world I believe “fear” focuses mostly on the financial wellbeing of an individual or a company.  What is so fascinating is that once we do the mental work and overcome our fear and do change, it becomes the new norm and, in our minds, the new habit or as Daniel Kahneman defines in his book Thinking, Fast and SlowA general “law of least effort” applies to cognitive as well as physical exertion. The law asserts that if there are several ways of achieving the same goal, people will eventually gravitate to the least demanding course of action. In the economy of action, effort is a cost, and the acquisition of skill is driven by the balance of benefits and costs. Laziness is built deep into our nature. (Kahneman, Daniel. Thinking, Fast and Slow (p. 35). Farrar, Straus and Giroux. Kindle Edition.)

For these basic human nature reasons, I believe disrupting clinical research will need to come from the patients rather than the current healthcare providers which, for the most part, are all too comfortable with the “least demanding course of action”.  Disruption will come from the patient because the patient will see the better value, especially as the pharmacist starts playing a bigger role in their overall health.  This will be achieved by the pharmacist working directly with the patients AND the medication sponsor studying a medication, whether that medication sponsor is a scientist, physician, institution or sponsor company.  It will be the pharmacist who brings the patient and the sponsor together so that the patient better understands ALL treatment options.  This is where the siteless model begins to change how clinical trials impact patients and how the patient is currently viewed—being a study subject.  Clinical trials should be all about benefiting the patient in both the near term and long term and must be another option in providing the best possible healthcare outcomes.

Patient Impact of the Siteless model.

In clinical research today, everyone is using the buzz term “patient centric”, but for the most part, patient centricity is being assimilated to make it work in the current model.  The question is: how do we stay true to the term?

To become patient centric, we must first understand who is assuming the risk.  Presently, clinical sites, CROs, and technology companies seem to be benefitting the most from clinical research.  They share little to no risk with the sponsor or the patient.  They get paid whether the patient benefits or not.  Sponsors take on the financial risk, but it is the patient who is truly taking all the REAL risks in a clinical trial.

The goal of the siteless model is to greatly reduce timelines and costs in addition to improving effectiveness so that the real risks—that of the patient—become the focus of the clinical trial rather than the business or financial risk.

For example, patients who participate in a trial must be able to learn and discuss what is happening when convenient for them.  The discussion should be with the medication expert who knows and is trained just how to talk with patients.  Then, if the medication is successful the patient should continue to receive the medication and counselling for free until the drug becomes a generic, because without the patient, the medication would not be on market.  While on the medication, the patient’s local pharmacist will continue to monitor the patient and be paid to do so by the developer to ensure continuity of counseling and further ensure compliance and adherence while collecting data and information and monitoring the continued efficacy and safety of the drug i.e.,  collecting real world evidence, completing MedDRA forms, etc.  In other words, all drugs should be treated as “specialty”.

Sponsor Impact of the Siteless Model:

Every month there is another article outlining the benefits of having pharmacists involved in patient care and ensuring positive patient outcomes.  The impact of the siteless model will be even greater for patients as the pharmacist takes the lead in ensuring patient outcomes and ensuring the patient is heard.  This will directly benefit the sponsor of the drug because they will have the opportunity to dramatically improve outcomes and increase their chances of success.  This has and will be achieved by pharmacists making real-time decisions with the patient, based upon real-time information that directly affects the outcome of the trial.  This has been proven by the work performed by trained Clinical Trial Research Pharmacists® (CTRP®) who are the cornerstone of the siteless model’s success.  To date, the CTRPs have made close to 30,000 patient calls.  All too often when the CTRP  talks with patients they hear things like, “I would never tell this to my doctor” or “I did not know that”.  Moreover, 9 out of 10 patients who the CTRPs talked to had a real-time intervention – protocol violation!  Of these interventions, more than 50% were of high impact.  This is why studies continue to fail drugs!  Siteless prevents this from happening.

Lessons Learned

The “white coat syndrome” is alive and well, especially when the physician is also the “scientist”.  How many patient surveys will we need to take to show that the current clinician focused trial makes the patient feel like a study subject.  During the CTRP calls, this was echoed again and again.  To change this, we need to fit the clinical trial into the patient’s current lifestyle so that THEY are not the ones who need to be fearful of change, but the opposite and welcome change.

CTRP surveys show that when patients talk with their pharmacist in a clinical trial there is better compliance, adherence and retention based upon data collected by the CTRP.  Of course, when there are real-time interventions, the baseline for non-compliance and adherence changes is all but eliminated, thus non-compliance becomes speculation—what a wonderful thing.

The most important lesson learned to date is the need to centralize information to a single expert source— the pharmacist.  This is the most significant aspect of the siteless model which I will cover in another blog.

The siteless model is new (as are virtual trials) and will continue to develop and build upon the CTRP’s 100% FDA approval rating and 100% nutraceutical claims.  It will also continue to learn from the myriad of studies showing the impact of pharmacist on healthcare and patient outcomes.

What do you think?

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