Harlan Krumholz Profile picture
Harold H. Hines Jr Professor, Yale Univ; Director, YNHH CORE; Editor-in-Chief, JACC. Working to improve the future for those who follow us...

Sep 24, 2020, 6 tweets

On the #COVID19 transparency front: JNJ has announced that they will share the Clinical Study Report and clinical trial participant data from their vaccine trial with researchers through @Yale Open Data Access (YODA) Project. @YaleMed @jsross119 @JNJNews jnj.com/coronavirus/le…

@Yale @YaleMed @jsross119 @JNJNews To provide context for the JNJ vaccine data sharing, @Yale YODA Project provides access to data to researchers w/ credible scientific proposal, agreement to report results, & commitment to protect participant privacy. Access decision is independent. yoda.yale.edu

@Yale @YaleMed @jsross119 @JNJNews To date, @Yale Open Data Access (YODA) Project has resulted in 42 submitted publications (31 published) based on JNJ participant-level data sharing. JNJ (Janssen) has committed to sharing data from all their drug and device trials through the YODA project. jnj.com/coronavirus/ou…

@Yale @YaleMed @jsross119 @JNJNews Also, as an aside, JNJ has also shared their protocol for their phase 3 vaccine trial. jnj.com/coronavirus/co…

@Yale @YaleMed @jsross119 @JNJNews So this should be the standard for all companies… share protocol, Clinical Study Report & clinical trial participant-level data. This transparency will increase trust in the process – & enable scientists around the world to study the studies and even extend what we are learning.

If all trial investigators adopt this type of transparency … and tenets of #openscience… we will be much better off in the end. Not just an issue for the pandemic studies… but good for the scientific enterprise overall.

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