Critical elements of patient centricity
Monday, July 13, 2015
The Pulse on Patient Recruitment by Ashley Tointon
Patient centricity is a buzz word that is often used in the clinical trials industry, but what does it really mean? According to a research paper in MicroMass, titled Can Pharma Stay Relevant?, “defining patient centricity is like trying to hit a moving target. Although not a formal definition, patient centricity basically means ‘putting the patient first.’” In order to put patients first in clinical research, you must ask important questions early in the planning process and actually apply the knowledge to the clinical trials that are being considered and implemented. While the interpretation of how to apply the concept varies greatly, it typically involves the gathering of patient preferences and insights.
Protocols for clinical trials often are planned by researchers, scientists and clinical operations staff without much consideration of the participants that will volunteer to be a part of it. The protocol for a clinical trial outlines the design, methodology and statistical considerations and ensures that the integrity of the data collected, safety procedures and documentation follow the ICH Good Clinical Practice guidelines. With so many detailed requirements from the guidelines to consider, many have inadvertently overlooked asking whether what they have outlined in the protocol is problematic from a patient perspective. It is easy to put the integrity of the data ahead of the people whose lives will be affected by the results, but it does not have to be that way.
Becoming patient centric requires a mental shift. One way to think about it is to ask yourself “Would I do that?” or better yet “Would I ask a loved one to do that?” Some things are pretty simple given a little foresight. People with certain disease states may have simple-to-overcome obstacles that you can either react to as they come about, or you can choose the proactive approach and take the time to discern what obstacles may exist before they arise. Take, for example, a clinical trial enrolling a patient population with spinal cord injuries. When the study failed to meet the enrollment targets, it was revealed that patients were willing to participate but were unable to physically get to the study site due to their condition. That particular type of spinal cord injury required ambulance transportation, which was not considered by the sponsor, nor the principal investigators conducting the trial. In this case, replacing site visits with home visits and contracting with a special transportation company reduced the burden of the patients—but the lack of patient insight costs months of costly trial delays.
There is a lot of data collected during a clinical trial, but most of it is clinical in nature. You may have a wealth of data about the size of legions after a psoriasis study concludes, but do you know what led the participants to volunteer in the first place? Do the volunteers receive any follow up regarding study results or are they asked to provide any type of feedback on their experience? Understanding what motivates patients and knowledge of the major obstacles to participation can aid in the design of more patient centric clinical research studies. The common goal of everyone in research, whether they are a researcher, principal investigator or the loved one of a participant, is the same—to improve lives through science.
Ashley Tointon has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry. Currently she provides recruitment expertise, strategy and leadership as Principal Consultant of Accelerate Clinical Enrollment LLC. Email comments and suggestions to email@example.com
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