A Short History of Patient Centricity

Michael Stadler, CEO and Founder

The calls for patient centric drug development are getting louder.

Patient centricity, while in the spotlight now, has been taking shape for nearly 30 years, although fragmented and with variable effects on health outcomes. In recent years, many sponsors have built infrastructure around a lifecycle approach to patient involvement. The impact of regulatory initiatives are taking shape. Around the world, patients are becoming more unified and organized, with the help of advocacy groups and technology.

Patient engagement as we know it today had its roots in the HIV/AIDS grassroots advocacy of the 1980s. In response, The FDA formed an office to work with patient advocates. This work was continued in the 1990s with the Patient Representative Program, soliciting the involvement of patients to inform regulatory decision-making through participation in advisory committees and panels. Today, the expanded program includes more than 300 diseases and conditions. In Europe, The European Community Advisory Board (a working group of the European AIDS Treatment Group) was set up in 1997 to communicate with industry and regulators, and to encourage availability of new drugs.

Select recent events in the evolution of patient perspectives in regulatory (EMA and FDA) and international platforms include:

  • Since its creation in 1995, The EMA has interacted with patients in every step of the regulatory lifecycle in the evaluation of medicines from pre-submission and evaluation through to post-authorization.
  • The framework of EMA interaction with patients’ and consumers’ organizations was adopted in 2005
  • In 2012: Patient engagement was a major focus of the 2012 PDUFA V reauthorization, which mandated the creation of a Patient Focused Drug Development program at FDA. FDASIA section 1137 expanded FDA authority to increase stakeholder involvement, among other provisions. A number of initiatives followed, including
    • The creation of the Office of Professional Affairs and Stakeholder Engagement (2014), to promote two-way engagement to enhance drug development and safety. It also seeks to enrich the experience of patients, advocacy groups, health care professionals, and agencies in engaging with FDA.
    • The Patient-Focused Drug Development initiative involved a broader, more systematic approach to gather patient perspectives to inform regulatory decision-making. Today, this initiative includes 21 diseases.
  • Also in 2012, patient representatives were included as full members of the EMA’s Pharmacovigilance Risk Assessment Committees, taking part in risk/benefit assessments.
  • The European Patients’ Academy (EUPATI) was formed in 2014 to help patients learn and become involved in the development of new medicines. Funded by The Innovative Medicines Initiative (IMI), this is Europe’s largest public-private initiative aiming to speed up the development of better and safer medicines for patients.

In the drug development process, there are many different components to a comprehensive patient-centric lifecycle approach. Incorporating the patient voice in research decisions, clinical trial design and support programs is fundamental. A number of emerging techniques are on the rise, including patient advisory panels, social media, as well as surveys and one-on-one interviews. At Clariness, we encourage patient centricity through upfront research with patients. Some of our recent projects involve a variety of patient outreach and research methods spanning psoriasis, kidney disease complications, and pain, among many other indications.

involving patients in planning and implementation not only guides teams in the development of more realistic protocols, but also opens up new ways of selecting sites, recruiting patients and building effective retention programs.

Ask Clariness about how we can help make your clinical development more patient centric.