Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey

Rhonda Facile   ¹ , MSc ;   Erin Elizabeth Muhlbradt   ² , PhD ;   Mengchun Gong   ^{3, 4} , MD ;   Qingna Li   ^{5, 6, 7} , MSc ;   Vaishali Popat   ⁸ , MPH, MD ;   Frank Pétavy   ⁹ , MSc ;   Ronald Cornet   ¹⁰ , PhD ;   Yaoping Ruan   ¹¹ , PhD ;   Daisuke Koide   ¹² , PhD ;   Toshiki I Saito   ¹³ , MD, PhD ;   Sam Hume   ¹ , DSC ;   Frank Rockhold   ¹⁴ , PhD ;   Wenjun Bao   ¹⁵ , PhD ;   Sue Dubman   ¹ , MA ;   Barbara Jauregui Wurst   ¹ , MSc, MD

¹ Clinical Data Interchange Standards Consortium, Austin, TX, United States

² Medical Science and Computing, a Guidehouse company, Rockville, MD, United States

³ Digital Health China Technologies, Bejing, China

⁴ Institute of Health Management, Southern Medical University, Guangzhou, China

⁵ Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China

⁶ Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine of National Medical Products Administration, Beijing, China

⁷ National Clinical Research Center for Chinese Medicine Cardiology, Beijing, China

⁸ Food and Drug Administration, Center for Drug Evaluation Research, Silver Spring, MD, United States

⁹ European Medicines Agency, Amsterdam, Netherlands

¹⁰ Department of Medical Informatics, Amsterdam Public Health Research Institute, Amsterdam University Medical Centers - University of Amsterdam, Amsterdam, Netherlands

¹¹ LinkDoc Technologies, Beijing, China

¹² Department of Biostatistics & Bioinformatics, Graduate School of Medicine, University of Tokyo, Tokyo, Japan

¹³ National Hospital Organization Nagoya Medical Center, Nagoya, Japan

¹⁴ Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States

¹⁵ JMP Life Sciences, SAS Institute Inc, Cary, NC, United States