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Siteless: Rethinking Clinical Research (Part 2 of 3)

July 25, 2018
Posted by: Gerald “Pharmacist Jerry” Finken, RPh, MS

Photo credit: Looney Tunes Wiki - Fandom

Photo credit: Looney Tunes Wiki – Fandom

In 1940 the Warner Bros. character Bugs Bunny first uttered the mischievous and somewhat insolent: “What’s up doc?”  With doctors leading the way in clinical research today, we need now to be asking the same question in order to create meaningful disruption.

In the past 40 years, many marvelous and life changing drugs have been approved and many lives have changed for the better. However, we can and should be doing better—much better.  During these same forty years only 1 in 10 drugs were approved by the FDA on the first submission and costs have increased by $1 billion dollars.  We should also keep in mind that it still takes 7-14 years for a successful drug to get approval.

Stating the obvious, doctors are important and society has rightly revered the doctor for centuries, placing this profession on the highest step of achievement. In the process though, society has lost sight of the high value of the pharmacist and the many contributions to healthcare by those in this profession.  It is time to open our eyes and broaden our thinking.  This blog is intended to disrupt traditional thinking and encourage you to look at healthcare in other ways that have already been adopted by Center Point Clinical Services’ siteless model and which make it different from other healthcare models:

  1. Consider an increase in healthcare leadership by the qualified pharmacist
  2. Reconsider the regulations surrounding the role of the physician and other healthcare professionals.
  3. Use technology better.

The siteless model utilizes the pharmacist as the key healthcare professional to achieve success in clinical research, reduce costs and greatly reduce timelines.  The siteless model shifts the focus from the clinical site to the patient, wherever they may be.  The siteless model is also different from the current “virtual” trials because the siteless model focuses on the pharmacist using technology as a tool to achieve desired outcomes versus focusing on technology to provide information to the clinician to achieve outcomes.  How?  I will talk about how our pharmacist did that in my next blog.

Within the framework of the siteless model, pharmacists collect not only patient data but also real-time information, including the intangible, from the patient, for immediate review and analysis.  The pharmacist is able to immediately address the issues or concerns of the patient that could influence study outcomes and avert a crisis or patient discontinuation in the study. This real-time review addresses the critical strategic challenge currently facing clinical research: the study failing the drug rather than the drug failing the study.  How do we fix this?  This is mostly due to the patient currently not having access to the healthcare provider at the time they have questions or concerns.  Who better than to speak to than the pharmacist who is the drug expert and has the most experience with talking with patients about their medication and their health.

The Chief Pharmacist Officer

The first thing the industry needs to do is to create and hire for the position of a Chief Pharmacist Officer whose key role is to implement true patient centricity into all aspects of the pharmaceutical industry, clinical research being just one of many patient-focused areas.  Pharmaceutical care must be holistic and not siloed into the research or commercial business entity.   All of the responsibilities of how a clinical research study is performed (the operations) should be the responsibility of the Chief Pharmacist Officer, just as it in the commercial setting.

In the commercial setting the pharmacist is responsible for the dispensing, counselling, compliance, adherence and patient outcome.  Though the Chief Medical Officer would continue to be responsible for diagnosis and developing the clinical protocol, the pharmacist would ensure that the study protocol is being properly carried out. This would include recruitment, dispensing, and monitoring the patient’s progress with the use of their medication.

Additionally, a pharmaceutical care protocol should be developed or included in the existing clinical protocol that outlines just how the medication will be prepared and dispensed and just how the patient is to receive, use and comply with the drug treatment.  The pharmaceutical care portion of the protocol would include information about how often the pharmacist speaks with the patient and the type of real-world information being documented and how this information would be utilized in real-time to ensure the best possible outcome for the patient. Bottom line—patient centricity starts with the pharmacist.

Henry Ford has been credited with saying “If I had asked people what they wanted, they would have said faster horses.”  We all know the impact Henry Ford had on disrupting the automobile industry and revolutionizing manufacturing, thus the impact of this statement—whether he actually said it or not.  When it comes to clinical research today, everyone is talking about patient centricity—what people want.  If you were to ask people today what they wanted in healthcare, they would say that they wanted more time with their clinician.  When in fact, what they are looking for is knowledge.  Patients –people—just want to learn.  They want to know more about their disease and related treatments, in terms they can understand.   They want information to make decisions and understand what they can do about it—information that fits their lifestyle and their socio-economic status.  The pharmacist has been providing this service for centuries, but it continues to be the best kept secret.

If we want more people to get involved in clinical research, it will not be through the clinician’s office, it will be at the local pharmacy.  Pharmacists have been the patient’s advocate for centuries and will ensure ALL patients are heard.  This will be a key element of the siteless model.  It will be truly patient centric which means clinical research would not only be about collecting patient data or patient participation but also true patient engagement where the patient would share in all aspects of the clinical trial and personally benefit from the study outcomes, no matter the outcome.  This means that clinical research would be another option in true patient care and not a means onto itself.

Regulations

Another key area that the siteless model will address is regulations.  Presently, there are two sets of regulations healthcare professionals must abide by to perform clinical research in the US: state and federal.  Federal regulations allow almost anyone to perform tasks as long as they are trained whereas state regulations require licensure.  Look at the current FDA guidance document on patient centricity: Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.  It is an excellent overview of what licensed healthcare professionals do every day “according to the art” including pharmacists.  A true siteless model focuses and relies on licensed professionals to address the patient’s health and their outcomes.   I should point out that state (or local) law is often overlooked for clinical research.  Such is the case in the US, as well as in Europe where the focus is on the federal or national regulations.  For clinical research to be part of a patient’s overall healthcare, we need to address the differences between state regulations which only allow licensed healthcare professionals to dispense medication and counsel patients and the federal law that has allows trained individuals to  provide healthcare for the patient.

Technology Use

The last thing I will touch on for the Siteless model is about the use of technology.  We all know that technology has not impacted clinical research like it should or could.  There are thousands of technology companies offering solutions to clinical research, just as they have been for 40 years without proving their ROI.  I believe this is because we are trying to replace the “trained” individual and the tasks they perform with technology.  While we absolutely can do more because of the tasks no longer needed to be performed by the trained individual, technology has yet to bring about significant cost and time reductions or get more drugs approved.  To change this, we need to disrupt the process with ideas like the siteless model and then use technology to make it simple and cost effective; e.g., Uber and Airbnb.

In Part III of this siteless series I will provide examples of the positive impact of pharmacists on clinical research and why the Siteless model will impact costs, time and approvals.

In the meantime, I’d like to know your thoughts about the above ideas.

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