How a 21st Century Cures 2.0 Could Support Patient Experience Data

The Academy of Oncology Nurse & Patient Navigators (AONN+) and more than 20 professional and advocacy organizations have announced their support of the newly proposed language in the 21st Century Cures 2.0 discussion draft that aims to improve patient experience data exchange for the clinical trial process.

The organizations, which represent millions of patients facing serious health conditions, expressed their approval of this proposed adjustment to the regulation in a letter to Diana DeGette (D-CO) and Fred Upton (R-MI), chairs of the House Energy and Commerce Committee.

The newly proposed language in Title II, Section 204, Patient Experience Data (PED), Subsection (b), Collection, Submission, and Use of Data, emphasizes the importance of patient experience data exchange for high quality care delivery.  

Patient experience data goes beyond physical symptoms or side effects of a disease, therapy, or clinical investigation, to address the preferences, needs, and psychosocial concerns of patients, the letter authors explained.

“Patient advocacy and patient empowerment are part of the core competencies of AONN+ as we work to provide oncology nurse and patient navigators with the tools and resources needed to ensure better patient care,” the organization wrote.

The letter outlined that the passage of the 21st Century Cures Act, as amended by the Food and Drug Administration Reauthorization Act of 2017 (FDARA), elevated the importance of patient experience data.

Additionally, the Food and Drug Administration (FDA) acknowledges that patient experience data provides unique insights to identify relevant clinical trial endpoints to inform product development, the letter authors noted.

However, there is currently no requirement to ensure that patient experience data is consistently gathered, submitted, and leveraged in the drug development process as intended, the authors explained.

“The new subsection (b) of Title II, Section 204 in Cures 2.0 will help actualize the intent behind the 21st Century Cures Act and the 2017 FDARA,” the letter authors wrote.

Specifically, the new language requires drug manufacturers/sponsors to collect and report on patient experience data as part of the clinical trial process. Additionally, the language requires FDA to fully consider all patient experience data collected during the clinical trial.

Lastly, the subsection mandates reporting of patient experience data in a transparent manner that is “uniform, meaningful, and informative to patients and providers,” the letter authors wrote.

Embracing standard processes for the collection, use, and exchange of patient experience data is set to help providers better address the full range of patient needs, they said. This, in turn, may boost participation in clinical trials generally and increase diversity among trial participants, the letter authors added.

Greater access to patient experience data could improve the shared decision-making process by better informing patients, caregivers, and providers about which treatment pathways may be best, they explained.

The importance of patient experience data exchange is also illustrated by The Institute of Medicine, concluding in 2008 that comprehensive cancer care must include psychosocial care, the letter authors noted.

“On behalf of the patients and caregivers we represent, we express our full support for the new subsection (b) of Title II, Section 204, Patient Experience Data, and urge that this language be included in the Cures 2.0 final legislation,” the authors wrote.