“Reinventing clinical research in the context of this continuum inevitably involves technology, ‘new science,’ and what is variously called patient-centricity, engagement, or empowerment,” said Mary Tobin, PhD, chief strategy officer and special adviser to the president and CEO of the Alliance for Clinical Research Excellence and Safety (ACRES).
“In essence, how can both research and health care take advantage of patient-focused end-to-end data and information generated in very large amounts throughout the continuum to transform processes and products for the benefit of the global patient as well as enterprise stakeholders as a whole,” said Tobin, who will be speaking on a panel about the reinvention of research next week at the 2019 Bridging Clinical Research and Clinical Health Care Conference.
The effect on research is far-reaching, she noted, and spans protocol design, site standards, as well as fully automated technology-enabled trials – “And that is just the start because the brave new world of the continuum represents a move from a competition to a collaboration model founded in formal systems thinking.”
What is clear, Tobin said, is that “the very size, complexity and current siloed nature of the clinical research environment—even where the need to transform clinical research is acknowledged—makes the act of reinvention no small challenge throughout the continuum.”
Of particular note in this paradigm shift is the patient’s role, which has been evolving from that of a “beneficiary and end-user” to a participant fully involved in decision-making.
Tobin said, “More recently, there has been an acknowledgment that a comprehensive understanding of how to best engage patients requires balancing the advances being made in technology (from wearables to sentiment analysis) with deeper qualitative research analysis to best uncover and meet patient needs.”
As the industry looks to reinvent research, Tobin said the interconnected nature of clinical research itself also has become more apparent. This has been seen in calls to break down functional silos, for taking a systems approach, and aligning various stakeholder interests – “a critical underpinning for bridging health care and research,” she explained.
Yet, to successfully unite clinical care and research, Tobin said the historical context of the separation must be taken into account.
“Separated after WW II, the artificial wall between health care and research, while well intended to protect the patient, created challenges with efforts to put the patient at the center of the continuum and actively involving them in trials,” she explained. “The ripple effect is still being felt from enrolment to end-points.”