From NYU: Person-Centric Clinical Trials: Ethical Challenges in Recruitment and Data Transparency for Improved Outcomes

J Clin Pharmacol. 2014 Apr 14. doi: 10.1002/jcph.308. [Epub ahead of print]

Person-Centric Clinical Trials: Ethical Challenges in Recruitment and Data Transparency for Improved Outcomes.

Robbins DA1, Curro FA, Mattison J.

Author information

• 1Integrated Decisions, Ethics, Alternatives and Solutions, Imperial Beach, CA, USA; Director of Health Policy, PEARL Translational Network, New York University, New York, NY, USA.

Abstract

Practitioners participating in clinical studies are faced with a number of ethical issues related to recruitment, informed consent, handling and transparency of data. Practitioners educated in Good Clinical Practice, applying the philosophy of person-centricity within a network utilizing risk-based monitoring and remote data entry can provide the requisite infrastructure and oversight to support person-centric clinical studies. While "patient-centered" clinical studies allow for a broader clinical outcome perspective beyond the investigator, the person-centric approach, accounts for the comprehensiveness and complexity of how we make health and healthcare decisions. Augmenting person centricity with comparative effectiveness studies allow for the inclusion of individual data significantly contributing to the aggregation of multiple data sets about individuals and populations. This enables more powerful and personal analytics and care and everyone is afforded the opportunity and privilege to contribute to improve clinical outcomes and in controlling and containing costs. Policy and institutional investment in infrastructure are prerequisite to accommodate these opportunities, to minimize abuses, and provide pathways for analyzing alternative healthcare patterns. Data provided will be comprehensive and robust, representative of use, with safety data more easily discernible from persons with a known past medical and health history.