Dr John Bridges Highlights Importance of Patient Preferences

Neglecting patient and caregiver preferences hamstrings the development of medical technologies and engaging these stakeholders is vital, said John Bridges, PhD, associate professor of the Johns Hopkins Bloomberg School of Public Health.

How are patients and caregivers being used in regulatory and drug development?

It’s a really exciting time for the patient and stakeholder engagement in the regulatory process. During the Patient-Focused Drug Development Initiative, which is being part of the authorization of the FDA and user-fee arrangements, there has been an ongoing series of 20 meetings where patients and other stakeholders are being offered an opportunity to provide their perspective into the regulatory process.

This has been a major leap forward for engaging patients in the process. It offers the opportunity to have testimony for the FDA to realize the real, lived experiences of patients, caregivers, and other stakeholders, about their disease, about treatments, and about unmet needs.

How much impact should patient and caregiver preferences have on this process?

Understanding the impact that the values of patients and caregivers have on the process of regulation is something that will evolve over the next 5 years. Many groups including the medical device industry, the pharmaceutical industry, the biotechnical industry, has asked really for the engagement of patients throughout the entire product development cycle from inception of technology all the way through post-marketing issues or pricing reimbursement.

There is a real need to get the end user. We see elsewhere in society the end user playing a major role, whether it’s in the phones that we have—Apple has been a real leader in end user involvement in the development of their technology—this is something that is just starting to happen, but it will become a vital force in healthcare. How that works out and the role that they play, I see this as an evidence-base.

Patient preferences are an important measurable concept that we can have and to neglect this is really hamstringing the development of medical technologies, and we really must get the end user involved in the development of technology.