Clinical Research Data Sharing Alliance

Registration is still open! We’re thrilled to invite you on Tuesday, January 28 and Wednesday, January 29 for a virtual summit hosted by CRDSA co-founder Virginia Nido and featuring a keynote address by Dr. Klaus Romero, Chief Executive Officer and Chief Science Officer at Critical Path Institute. Look forward to unique discussions and panels held by representatives from across the data sharing community.  Tuesday, Jan 28, 10 AM-12 PM EST Data Reuse: Navigating the Regulatory Environment Kicking off with a keynote address by Dr. Klaus Romero, the first day of the summit will explore the current state of patient data reuse in the regulatory approval process. Wednesday, Jan 29, 10AM-12 PM EST Demystifying the EU Data Sharing Space On the second day we’ll be discussing all about the European data space. Sessions will address how these initiatives work together (and where they don’t), with a focus on the role of industry, both as data providers and data users. Register Today → https://lnkd.in/eN8PziBC #datasharing #patientdata  #clinicaldata #clinicalresearch #datastandards #RWD #RWE

Please join us on Tuesday, January 28 and Wednesday, January 29 for a virtual summit hosted by CRDSA co-founder Virginia Nido and featuring a keynote address by Dr. Klaus Romero, Chief Executive Officer and Chief Science Officer at Critical Path Institute (C-Path). Tuesday, Jan 28, 10 AM-12 PM EST Data Reuse: Navigating the Regulatory Environment Featuring a keynote address by Dr. Klaus Romero, the first day of the summit will explore the current state of patient data reuse in the regulatory approval process. Learn why responsible data reuse is a critical tool in future trial design, how the totality of evidence can inform the drug development process, and what’s needed to meet regulatory use challenges. Wednesday, Jan 29, 10AM-12 PM EST Demystifying the EU Data Sharing Space The second day of the summit is all about the European data space. What will be the impact of the European Health Data Space? What’s on the horizon for IHI/IMI projects like FACILITATE and IDEHRA? How will EMA’s DARWIN EU be used to inform regulatory decision-making? Sessions will address how these initiatives work together (and where they don’t), with a focus on the role of industry, both as data providers and data users. Register Today → https://lnkd.in/eN8PziBC #datasharing #patientdata  #clinicaldata #clinicalresearch #datastandards #RWD #RWE

Would you like to learn more about our new standards and how they intersect with decentralized trials? Join this Friday's conversation with Aaron Mann, Virginia Nido, and Decentralized Trials & Research Alliance (DTRA)!

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

CRDSA is pleased to announce the publication of standards for clinical trial data reuse. “The standards are complementary and intended to work together to facilitate good science,” said Ramona Walls, Executive Director of C-Path and Co-Chair of the CRDSA Secondary Use Standards Work Group. “They establish consistent guidelines for responsibly sharing clinical study data and conducting robust secondary analyses of that data to advance scientific knowledge.”   CRDSA Std 1001: Standard for Sharing Clinical Study Data promotes data completeness, consistency, interoperability, and information transparency.   CRDSA Std 2001: Standard for Secondary Analysis of Clinical Study Data aims to help researchers conduct robust analyses and objectively interpret the findings generated from the use of shared patient data.   These standards mark both a milestone for CRDSA and an important next step in expanding the research value of patient data. We’d like to thank the CRDSA standards working group — Ramona Walls (C-Path), Ernest A. Odame (Takeda), Peter Mesenbrink (Novartis), Luk Arbuckle (IQVIA), Andrei Belcin (Privacy Analytics), Radoslaw Polanski (AstraZeneca), Chris Hoffman (Forum for Collaborative Research), and co-chair Yefei Z. (Takeda) — for their extraordinary effort over the last three years. To download CRDSA Std 1001: https://lnkd.in/eyxz9G6u To download CRDSA Std 2001: https://lnkd.in/ewX9jNSU #patientdata #datastandards #clinicaldata #datasharing #clinicalresearch

Aaron Mann recently joined RWD & RWE Club hosts Aaron Kamauu MD MS MPH and Matt Veatch for a wide-ranging conversation on the challenges and opportunities presented by real world data/real world evidence and how CRDSA’s work comes into play. If you missed “Real World Wednesday,” that live discussion is now available as a podcast at: https://lnkd.in/eUunPqxV #rwd #rwe #clinicalresearch 

CRDSA welcomes new board members Stephen Pyke, Parexel's Chief Clinical Data & Digital Officer, and Veronica Miller, Director of The Forum for Collaborative Research. We are thrilled to add their experience and perspective to our board of directors. #datasharing #clinicaldata #clinicalresearch

In late February we released two secondary use draft standards for public comment. We’ve enjoyed discussing them with our community in the weeks since, and now the time has come to act. Would you like a say on these standards? Please submit your comments by 11:59 p.m. EDT on May 31, 2024. For more on the Standard for Sharing Clinical Study Data: https://lnkd.in/eyCuxAws   For more on the Standard for Secondary Analysis of Clinical Study Data: https://lnkd.in/ehtW7KR6   NOTE: The comment submission form is linked in each document. #patientdata #datastandards #clinicaldata #datasharing #clinicalresearch

“We can't stay in our data bubbles. We truly have an ethical imperative to interrogate data to the maximum potential that we can.” Those were the stakes described by Virginia Nido as she kicked off the closing session of our 2024 summit, which featured some of our founding board members. This short video shares a few highlights from that discussion. Hear from Virginia, Andrew Morris (Health Data Research UK (HDR UK)), Frank W. Rockhold, PhD, Peter Mesenbrink, and Peder Blomgren on CRDSA’s value to the data reuse ecosystem, the benefits of being a member, and how our work advances the science and ultimately serves patients. What do you think is needed to build a "trustworthy data ecosystem at scale"? Let us know in the comments. To watch: https://lnkd.in/eBJ2yWaA #patientdata #clinicaldata #datasharing #clinicalresearch

Do you use clinical trial data for secondary research? Join Frank W. Rockhold, PhD (Duke Clinical Research Institute), Andrew Freeman, and Aaron Mann this Wednesday, April 10, for an informational webinar on CRDSA’s Standard for Secondary Analysis, which was recently released for public comment. Learn more about how the standard will enable the conduct of good science and promote responsible secondary research use. Register today to help us shape this standard: https://lnkd.in/eM_hfz-r #patientdata #datastandards #clinicaldata #datasharing #clinicalresearch