On Monday and Tuesday of this week, CBI's 9th Forum on Patient Reported Outcomes was held in Philadelphia. The expert presenters from pharma, CROs, service providers and academic health centers covered a variety of topics on how to ensure the validity of PRO concepts, patient data and new technologies.
The co-chairs of the event, Ari Gnanasakthy, Executive Director, HE&OR, Novartis, and Susan Vallow, Director for Patient Reported Outcomes at Janssen Global Services, LLC, noted the following emerging themes from the conference as important to the PRO audience in the upcoming months: FDA/EMA regulations; increasing use of PRO in the post-registration environment; how best to use PRO as a quality measure; mixed modality usage and how new collaborative initiatives across the industry are being used to combat inefficiencies in development and how they impact PROs.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.