Tuesday, July 14, 2015

Facilitating Drug Development:
Optimizing the Person-Provider Encounter

By Frederick A. Curro, D.M.D. Ph.D.
Director, PEARL Clinical Translational Network
Clinical Professor, New York University

The Affordable Care Act (ACA) has broadened the responsibility of health and healthcare to include the person as well as when they become a patient. It has also widened the perspective on how we view health and healthcare recognizing that they are dependent variables where the outcome of one affects the outcome of the other. It can be viewed as a continuum where the person may experience becoming a patient many times in the course of their life but for the most part their health would be dependent upon what they do as a person.

This movement from healthcare to health and away from disease management has the person becoming an active participant in the outcome of their own healthcare. This concept of shared responsibility has the patient responsible for their compliance to both their health and healthcare. Medications can no longer be a substitute for a lifestyle that brought on the condition without the patient becoming more aware of lifestyle changes to possibly avoid the condition in the first place. The ACA has caused the present healthcare system to be introspective. Considering what the fixed variables would be in a new healthcare paradigm the person/patient encounter is the single most important aspect that one can consider to be a starting point. Other aspects of health and healthcare such as cost of drugs and drug development can be affected by this encounter if they are considered as dependent variables in an integrated system. 

Integrating the principles of clinical research with clinical practice to conduct person-centric clinical trials is one way of optimizing the person/patient encounter for an integrated system. Such a system can reduce drug development costs, facilitate the dissemination of current information to optimize clinical practice by closing the scientific gap from bench to practice, and provide an infrastructure for quality assured data that can be used for decision making purposes and incorporated in the “big data” concept.

Raising the person/patient/provider from an observational encounter to the level of a quality assured data point translates the medical encounter to a usable data point for best practice, submission to regulatory agencies for phase III and IV clinical studies, and creates an audit trail for both the provider and person/patient. It also provides a means for transparency and health care literacy. The audit trail for the provider can be used to lessen multiple claims that contribute to cost increases and fraudulent claims. The audit trail for the person keeps the person/patient informed to maintain a level of continued compliance to reduce further complications and/or to increase the treatment outcomes.

The missing component from many health care programs is an infrastructure that connects patients/persons with providers and third party payers. All of these moving parts should be in sync to optimize the efficiency of the system. Point-of-care quality assured data can lower the developmental costs for pharmaceutical companies to conduct clinical studies, provide meaningful patients that would be on the medication with a known medical history. Patients would be informed for their assessment and input, and side effects would be more interpretable to providers reporting the effects of the medication as the patient’s medical history would be transparent. In addition, patient compliance on the use of the medication would be improved as they have a vested interest under the concept of person/patient-centered care, recruitment costs to a study would be reduced to a minimum, and the data generated by the providers would be more readily accepted by the profession at large. 

Improving the person/patient encounter to a quality assured data point reduces the intensity and costs of oversight and the data can be cross referenced by many of the healthcare partners. This model proposes to integrate many of the steps in health and healthcare that are currently discrete and make them continuous and dependent upon each other so that the system is optimized and readily utilizable by the profession and the person/patient. The process would contribute to lessening the scientific gap by facilitating information transfer to the practitioners. 

Frederick A. Curro, D.M.D., Ph.D.

Frederick A. Curro is currently a Clinical Professor at New York University where, under the auspices of an NIH grant he and two colleagues built and directed “Practitioners Engaged in Applied Research & Learning” (PEARL) a Practice Based Translational Network. PEARL conducts person-centric clinical trials to improve health and healthcare delivery and conducts comparative effectiveness clinical studies for best practice.

Curro’s pharmaceutical career has included positions as Vice President of GlaxoSmithKline; Corporate Vice President of Clinical, Medical & Regulatory Affairs at the Block Drug Co. Inc.; Head of Reed & Carnrick Pharmaceutical, a division of Block Drug; and Executive Director of Clinical Operations & Research at Transkaryotic Therapies (TKT) Inc. of Cambridge, MA.

Curro was also a former Professor and Chairman, Department of Pharmacology at Fairleigh Dickinson University and has held faculty positions at the University of Texas at Houston and SUNY/Buffalo. His clinical expertise is in pain management.

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