1 PPD, Part of Thermo Fisher Scientific, 929 North Front Street, Wilmington, NC, 28401-3331, USA. Rakhi.kilaru@ppd.com.
2 Biometrics, Medical and Nutritional Science, Danone Nutricia Research, Utrecht, The Netherlands.
3 Central Statistical Monitoring (CSM), Data Science and Digital Innovations (DSDI), Global Statistical and Data Sciences (GSDS), BeiGene, Wuhan, China.
4 Roche Products Ltd, 6 Falcon Way, Shire Park Welwyn, Garden City, AL7 1TW, UK.
5 MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
6 Data Science and Digital Innovations (DSDI), Global Statistical and Data Sciences (GSDS), BeiGene, Fulton, MD, USA.
7 Center of Excellence for Statistical Innovation (CESI), Statistical Sciences & Innovation (SSI), UCB BIOSCIENCES GmbH, Alfred-Nobel-Strasse 10, 40789, Monheim, Germany.
8 Health Data Insights and Design, Global Clinical Operations, Novartis Healthcare Pvt. Ltd, Hyderabad, India.
9 Central Monitoring and Data Analytics, Global Clinical Operations, GSK, Warsaw, Poland.
10 SGH Warsaw School of Economics, Warsaw, Poland.
11 ALK, Bøge Alle 1, Hørsholm, Denmark.
12 Central Monitoring and Data Analytics, Global Clinical Operations, GSK, London, UK.