How (and why) CROs are collecting and using patient-centric data

Digital health technologies​ range from mobile health (mHealth), health information technology (IT), wearable devices​, to telehealth, and personalized medicine. Today, these technologies​ are used to assess disease, movement, social interactions, among other physiological variables.

Jennifer Christian, MPH, PharmD, PhD Vice President of Clinical Evidence, Real-World and Late Phase Research at Quintiles​ discussed the use of technology to capture real-world patient experience at BIO International​ last week in San Francisco, California.

“With these advances in technology, real world patient experiences can be efficiently captured and incorporated in the evaluation of clinical effectiveness and safety of treatments​,” Christian told Outsourcing-Pharma.com.

According to Christian, capturing​ these experiences has become more important as the health system refocuses on delivering patient-centered care; especially, as patients themselves call for measuring and reporting such aspects of health.

“I recall from a few years ago a patient with multiple sclerosis stating that she knew when her medicine was working well before any test or physician would measure its impact and that was because she could feel the fatigue go away as if ‘a cloud had been lifted​,’” Christian said.

“The benefits of the medicine took effect quickly for her and made an impact on her daily life that would not have been captured from a lab test, imaging, or clinician evaluation​.”

As Christian explained, this is just one of many examples in which symptoms and the impact of daily living are important to contextualize treatment benefits – and that otherwise would not be measured. 

Common issues​

After successfully selecting which measures to collect and how best to administer them, there are always hurdles to consider with implementing them.

According to Christian, the most common issues to consider are if translation or validations are needed based on the countries involved in the study, which includes using the patient voice to understand the questions.

Another issue is consistency in the delivery approach, specifically, making sure there are standardized processes and procedures in place to minimize variability, reduce risk of missing data, and minimize the risk of irregularities in how data are collected or completed. 

“The keys to overcome these barriers are using well defined standard operating procedures, planning appropriately, including patients in the development of the tools, and monitoring the completeness of information captured​,” she added.

Shared goals​

CROs are using patient-centric​ data in a variety of ways, engaging with patients early and often as participants in study design and conduct.

“Specifically, greater attention has focused on the need to conduct research that answers questions and examines outcomes that are important to patients, their caregivers, and clinicians​,” explained Christian.

The main goal of collecting and making use of patient-reported data​ is to increase the likelihood that the evidence produced will be used to support clinical and health policy decisions – addressing concerns that clinical evidence often fails to meet end-user needs.

“Patients can provide perspective on what’s important for a study to be able to meet their needs and expectations, how investigators can best engage with patients, how to best collect the required data, and how the patient registry could provide additional value to patients beyond data collection​,” said Christian.