Patient-Centricity: Empower and inform patients making them partners in the research process

In recent years, the American healthcare system as a whole has attracted a great deal of scrutiny, which has heralded a continuous series of efforts aimed at improving and optimizing the system. In the midst of such developments, a question has emerged for those with a stake in the drug development process: How can the field of clinical research keep pace with molecular discoveries without compromising the integrity of clinical trials? The answer lies in the concept of patient-centricity.

A “patient-centric” clinical trial is defined as one in which subjects act as partners in the research process; they are thoroughly educated as to the nature of the trial and its associated risks, and their feedback is highly valued by researchers.¹ This concept contextualizes clinical data, which becomes more meaningful when considered in light of patients’ experiences and comments.² The adoption of such a model calls for the realization that patient involvement is absolutely indispensable as an ingredient for a successful series of clinical trials.

Increased attention to the needs and comfort levels of patients enrolled in clinical trials is essential for a variety of reasons both technical and subjective. On the most basic level, it is important to ensure that patients feel empowered and well informed because the ease of acquiring information nowadays has engendered a thirst for knowledge in many people. Such patients will likely not be satisfied by an overly simplified explanation of a clinical trial.

Furthermore, proactive efforts to ensure that patients taking part in clinical trials feel comfortable and autonomous will create a more gratifying, pleasant experience for all parties involved. This will generate a positive sentiment about the organization conducting the clinical trial, which will likely encourage more patients to take part in their future trials.

There are several ways in which research organizations can endeavor to make their clinical trials more patient-centric. These include providing staff with the appropriate training so as to ensure that they are sensitive to patients’ needs and comfort levels, particular where invasive procedures are concerned. This could also include the integration of technological devices into the clinical trials process; technology that allows patients to independently gain access to relevant information can help ensure that they have agency in making their healthcare decisions. Irrespective of the specific techniques employed, it has become clear that patient-centricity is a concept to which all organizations conducting clinical trials must attend.

¹Sharma, NS. “Patient centric approach for clinical trials: Current trend and new opportunities.” Perspect Clin Res. 2015 Jul-Sep; 6(3): 134-138 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4504054/

²Ellis, LM. “American Society of Clinical Oncology Perspective: Raising the Bar for Clinical Trials by Defining Clinically Meaningful Outcomes.” JCO April 20, 2014 vol. 32 no. 12 1277-1280 http://jco.ascopubs.org/content/32/12/1277.short