An Interesting Collaboration
Patient-centered website partners with the FDA for drug safety surveillance.
PatientsLikeMe® (www.patientslikeme.com) is a patient-centered organization that helps its 350,000 members connect with one another. The website also offers a mechanism where patients can enter and track their medical data, and the organization has used some of this data in its research studies. The data that is generated is considered “real world” data since it is self-reported by the patients.
On June 15, 2015, the FDA announced that it had signed a research collaboration agreement with PatientsLikeMe to determine how patient-reported data can give new insights into drug safety. Both organizations recognize that clinical trial data represents only the experiences of the patients enrolled in the trials; whereas post-approval drug surveillance data are more expansive and more representative of the general population.
The PatientsLikeMe organization recognized the FDA’s action to evaluate newer sources of data to help identify drug risks and benefits, and note the reporting landscape is now changing from healthcare professionals reporting post-approval drug effects to engaging patients to directly report these effects.
Maintained QOL, Neurological Function Support T-DXd Safety and Efficacy in HER2+ mBC
December 20th 2024In line with its safety and efficacy profile, T-DXd preserved quality of life and neurological function in patients with HER2-positive metastatic breast cancer, irrespective of brain metastases.
