Manuscripts
Barrett, J. S., Bucci‐Rechtweg, C., Amy Cheung, S. Y., Gamalo‐Siebers, M., Haertter, S., Karres, J., ... & Zeitler, P. (2020). Pediatric extrapolation in type 2 diabetes: future implications of a workshop. Clinical Pharmacology & Therapeutics, 108(1), 29-39.
Gamalo‐Siebers, M., Savic, J., Basu, C., Zhao, X., Gopalakrishnan, M., Gao, A., ... & Carlin, B. P. (2017). Statistical modeling for Bayesian extrapolation of adult clinical trial information in pediatric drug evaluation. Pharmaceutical statistics, 16(4), 232-249.
Gamalo-Siebers, M., Hampson, L., Kordy, K., Weber, S., Nelson, R. M., & Portman, R. (2019). Incorporating innovative techniques toward extrapolation and efficient pediatric drug development. Therapeutic innovation & regulatory science, 53(5), 567-578.
Cooner, F., Gamalo-Siebers, M., Xia, A., Gao, A., Ruan, S., Jiang, T., & Thompson, L. (2020). Use of alternative designs and data sources for pediatric trials. Statistics in Biopharmaceutical Research, 12(2), 210-223.
Seifu, Y., Gamalo-Siebers, M., Barthel, F. M. S., Lin, J., Qiu, J., Cooner, F., ... & Walley, R. (2020). Real-World Evidence Utilization in Clinical Development Reflected by US Product Labeling: Statistical Review. Therapeutic Innovation & Regulatory Science, 54, 1436-1443.
Presentations
JSM 2018:
UCSF: Statistical Implications of Extrapolation in the Design and Analysis of Pediatric Clinical Trials Margaret Gamalo, PhD
Webinar; Incorporating Innovative Techniques Toward Extrapolation and Efficient Pediatric Drug Development, Margaret Gamalo
PSI: Statistical modeling for Bayesian extrapolation of adult clinical trial information in pediatric drug evaluation Authors: Margaret Gamalo‐ Siebers and the pediatric subteam of the Drug Information Association Bayesian Scientific Working Group and Adaptive Design Working Group Pharmaceutical Statistics, Vol 16, Issue 4, July/August 2017
Innovative Analytic Approaches in the Context of a Global Pediatric IBD Drug Development Margaret Gamalo-Siebers, PhD DA/ UMD CERSI Pediatric Inflammatory Bowel Disease Drug Development Workshop November 16, 2018Pediatric Inflammatory Bowel Disease (IBD) Workshop | Center of Excellence in Regulatory Science and Innovation (umd.edu)
A BAYESIAN APPROACH TO INCORPORATING ADULT CLINICAL DATA INTO PEDIATRIC CLINICAL TRIALS Jingjing Ye and James Travis, Office of Biostatistics (DB V and II)
Ye, J., “Master Protocol in Cancer Trials”, Hodgkin’s Lymphoma Working Group, Children’s Oncology Group (COG) Spring Meeting Mar., 2021, Virtual
Ye, J., “Improving early futility determination by learning from external controls in pediatric cancer clinical trials”, in Session “Design and Statistical Issues for Pediatric Oncology Trials”, 2020 International Chinese Statistical Association (ICSA) Annual Meeting, Dec. 2020
Ye, J., “A Review of the experience of pediatric written requests issued for oncology drug products”, in session “Innovative statistical methods for optimal treatment selection and clinical trial design”, 2020 International Chinese Statistical Association (ICSA) Annual Meeting, Dec. 2020
Ye, J., “A Bayesian approach in design and analysis of pediatric cancer clinical trials”, PSI Journal Club: Bayesian Methods, Nov. 17, 2020
Ye, J., “Master Protocol in Pediatric Cancer Trials”, ASA Biopharmaceutical Regulatory/Industry Statistical Workshop, 2020, Washington DC, Sep., 2020
Ye, J., “Ahead of FDARA Section 504 Implementation: Years in Review and Years Ahead in Pediatric Cancer Clinical Trials”, 2019 New England Rare Disease Statistics (NERDS) Workshop, Boston, MA, Oct., 2019
Ye, J., “Statistical and regulatory considerations on registrational trials in pediatric cancer”, 2019 International Chinese Statistical Association Symposium, Raleigh, NC, Jun., 2019.
Ye, J., “Bayesian Approaches to Incorporating Prior Knowledge into Pediatric Cancer Clinical Trials”, The 16 th Annual Accelerating Anticancer Agent Development and Validation (AAADV) Workshop, Bethesda, MD, May 2019.
Ye, J., “Statistical and regulatory considerations on registrational trials in pediatric cancer”, The 3 rd Stat4Onc Symposium, Hartford, CT, Apr. 2019.
Ye, J., “Borrowing information from adult studies into pediatrics trials: Bayesian approach and a case study”, 2018 International Chinese Statistical Association Symposium, New Jersey, Jun., 2018.
Ye, J., Travis, J., “A Bayesian Approach for Incorporating Adult Clinical Data into Pediatric Clinical Trials”, Invited Session of “Model Informed Pediatric Drug Development and Simulation”, Pediatric Trial Design and Modeling: Moving into the next decade, FDA Great Room, Silver Spring, MD, Sep. 8, 2017.
Podcast: Feb 25, 2021 Episode 86: Pediatric Drug Development Scientific Working Group: Meg Gamalo and Jingjing Ye talk about pediatric drug development and discuss why forming a scientific working group was so important. https://podcasts.google.com/feed/aHR0cHM6Ly93d3cuYnV6enNwcm91dC5jb20vMTYyOTYucnNz