Our own Dr. Robert Miller weighs in in this white paper published by Clinical Research Data Sharing Alliance. We are proud to serve in this important effort to make the best and most ethical use of data to further research and treatment options to benefit cancer care for all. #RWD #realworlddata #clinicaltrials
Just Published! CRDSA’s white paper “Data Reuse in Regulatory Submissions: The Role of Data Platforms” examines the benefits and challenges of using supplemental and external controls in regulatory submissions. Data platforms are an integral part of the ecosystem, enabling trial sponsors to access and use patient data from real-world settings and prior clinical trials. The paper recommends specific steps data platforms can take to support sponsors in meeting health authority expectations. You can download the paper here: https://lnkd.in/gZj6BMNr We want to recognize the incredible effort of the members of our Innovative Trial Design work group and governance committee. Thank you for your dedication and insight -?Emily Brouwer (Parexel), Bhavani Krishnan , PhD (Amgen), Ernest A. Odame (Takeda), Laura Fernandes (COTA), Marcia Levenstein (Vivli), Jon McDunn (Project Data Sphere), Andrew Belli (COTA), Robert Miller (CancerLinQ?), Peter Mesenbrink (Novartis), Jules Desmond (Amgen), Li Zheng (Genentech), Lynn Sanders (Takeda), Andrew Freeman (CRDSA), and Aaron Mann (CRDSA). #patientdata #RWD #RWE? #clinicaldata #datasharing #clinicalresearch #FDA #datastandards