New FDA website is providing patients and healthcare providers access to patient-reported outcomes to support shared decision making
By Subanya Karan
With patient-centric healthcare growing in recent years, more and more attention has been put towards patient-reported outcomes. Every single day researchers are conducting multitudes of clinical trials to yield data about how the latest advances in treatment can impact a disease. Ultimately this data will be assessed by clinicians to determine if new treatments could be a viable option for their patients. However, could some data be missing? For example, how do patients feel when they’re taking the medicine? This type of question and others like it can and should be answered by patients themselves through patient-reported outcomes (PRO).
Unfortunately, PRO data is often inaccessible. As a response, the Food and Drug Administration’s Oncology Centre of Excellence recently launched Project Patient Voice.
Project Patient Voice is “an online platform for patients and caregivers along with their healthcare providers to look at patient-reported symptom data collected from cancer clinical trials.” The website is currently in its pilot phase and will progress to include a list of cancer trials that have PRO data available. This data will come directly from patients using the PRO-CTCAETM questionnaire.
The first cancer trial PRO data being piloted on the website involves data relating to AstraZeneca’s AURA3 trial of Tagrisso (osimertinib) for non-small cell lung cancer. The website will display a table of patient-reported data, which has historically only been analyzed by the FDA during the drug approval process, but not available to the public.
According to Dr. Abernethy, FDA Principal Deputy Commissioner, “The Project Patient Voice pilot is a significant step in advancing the patient-centred approach to oncology drug development. Where patient-reported symptom information is collected rigorously, this information should be readily available to patients.”
The site is intended to give patients and caregivers realistic and accurate information that can be used as the foundation for shared decision-making between patients and health care providers. This is an exciting step forward in healthcare.
Subanya Karan is an account manager with Bridge Medical Communications.