Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 Guidelines
Singh, Rominder, Wang, William, Chakravarty, Aloka, Wang, Jun, Uyama, Yoshiaki
Published in Therapeutic innovation & regulatory science (01.09.2024)
Published in Therapeutic innovation & regulatory science (01.09.2024)
Get full text
Journal Article
Describing characteristics and treatment patterns of patients hospitalized with COVID-19 by race and ethnicity in a national RWD during the early months of the pandemic
Vititoe, Sarah E, Easthausen, Imaani J, Lasky, Tamar, Chakravarty, Aloka, Bradley, Marie C, Roe, Laura M, Gatto, Nicolle M, Weckstein, Andrew R, Garry, Elizabeth M
Published in PloS one (26.09.2022)
Published in PloS one (26.09.2022)
Get full text
Journal Article
Real-world utilization of SARS-CoV-2 serological testing in RNA positive patients across the United States
Rodriguez-Watson, Carla V, Sheils, Natalie E, Louder, Anthony M, Eldridge, Elizabeth H, Lin, Nancy D, Pollock, Benjamin D, Gatz, Jennifer L, Grannis, Shaun J, Vashisht, Rohit, Ghauri, Kanwal, Valo, Gina, Chakravarty, Aloka G, Lasky, Tamar, Jung, Mary, Lovell, Stephen L, Major, Jacqueline M, Kabelac, Carly, Knepper, Camille, Leonard, Sandy, Embi, Peter J, Jenkinson, William G, Klesh, Reyna, Garner, Omai B, Patel, Ayan, Dahm, Lisa, Barin, Aiden, Cooper, Dan M, Andriola, Tom, Byington, Carrie L, Crews, Bridgit O, Butte, Atul J, Allen, Jeff
Published in PloS one (10.02.2023)
Published in PloS one (10.02.2023)
Get full text
Journal Article
When can real‐world data generate real‐world evidence?
Rahman, Motiur, Dal Pan, Gerald, Stein, Peter, Levenson, Mark, Kraus, Stefanie, Chakravarty, Aloka, Rivera, Donna R., Forshee, Richard, Concato, John
Published in Pharmacoepidemiology and drug safety (01.01.2024)
Published in Pharmacoepidemiology and drug safety (01.01.2024)
Get full text
Journal Article
Improving data capture of race and ethnicity for the Food and Drug Administration Sentinel database: a narrative review
Ter-Minassian, Monica, DiNucci, Anna J., Barrie, Issmatu S., Schoeplein, Ryan, Chakravarty, Aloka, Hernández-Muñoz, José J.
Published in Annals of epidemiology (01.10.2023)
Published in Annals of epidemiology (01.10.2023)
Get full text
Journal Article
Categorization of COVID‐19 severity to determine mortality risk
Garry, Elizabeth M., Weckstein, Andrew R., Quinto, Kenneth, Bradley, Marie C., Lasky, Tamar, Chakravarty, Aloka, Leonard, Sandy, Vititoe, Sarah E., Easthausen, Imaani J., Rassen, Jeremy A., Gatto, Nicolle M.
Published in Pharmacoepidemiology and drug safety (01.07.2022)
Published in Pharmacoepidemiology and drug safety (01.07.2022)
Get full text
Journal Article
Perspectives on statistical strategies for the regulatory biomarker qualification process
Hendrix, Suzanne B, Mogg, Robin, Wang, Sue Jane, Chakravarty, Aloka, Romero, Klaus, Dickson, Samuel P, Sauer, John-Michael, McShane, Lisa M
Published in Biomarkers in medicine (01.06.2021)
Published in Biomarkers in medicine (01.06.2021)
Get full text
Journal Article
Review of Oncology and Hematology Drug Product Approvals at the US Food and Drug Administration Between July 2005 and December 2007
Sridhara, Rajeshwari, Johnson, John R., Justice, Robert, Keegan, Patricia, Chakravarty, Aloka, Pazdur, Richard
Published in JNCI : Journal of the National Cancer Institute (24.02.2010)
Published in JNCI : Journal of the National Cancer Institute (24.02.2010)
Get full text
Journal Article
Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association
Gruber, Susan, Chakravarty, Aloka, Heckbert, Susan R., Levenson, Mark, Martin, David, Nelson, Jennifer C., Psaty, Bruce M., Pinheiro, Simone, Reich, Christian G., Toh, Sengwee, Walker, Alexander M.
Published in Pharmacoepidemiology and drug safety (01.09.2016)
Published in Pharmacoepidemiology and drug safety (01.09.2016)
Get full text
Journal Article
Describing characteristics and treatment patterns of patients hospitalized with COVID-19 by race and ethnicity in a national RWD during the early months of the pandemic
Sarah E. Vititoe, Imaani J. Easthausen, Tamar Lasky, Aloka Chakravarty, Marie C. Bradley, Laura M. Roe, Nicolle M. Gatto, Andrew R. Weckstein, Elizabeth M. Garry
Published in PloS one (01.01.2022)
Get full text
Published in PloS one (01.01.2022)
Journal Article
A Descriptive Cohort Study of Drug Utilization Patterns Among Patients Hospitalized With Coronavirus Disease 2019 in the United States, January 2021–February 2022
Vititoe, Sarah E, Govil, Priya, Baglivo, Aidan, Beebe, Elisha, Garry, Elizabeth M, Gatto, Nicolle M, Lasky, Tamar, Chakravarty, Aloka, Bradley, Marie C, Perez-Vilar, Silvia, Rivera, Donna R, Quinto, Kenneth, Clerman, Andrew, Rajpal, Anil, Frajzyngier, Vera
Published in Open forum infectious diseases (01.07.2023)
Published in Open forum infectious diseases (01.07.2023)
Get full text
Journal Article
Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association: Safety Study Design and Analysis Choices Need Tuning
Gruber, Susan, Chakravarty, Aloka, Heckbert, Susan R., Levenson, Mark, Martin, David, Nelson, Jennifer C., Psaty, Bruce M., Pinheiro, Simone, Reich, Christian G., Toh, Sengwee, Walker, Alexander M.
Published in Pharmacoepidemiology and drug safety (01.09.2016)
Published in Pharmacoepidemiology and drug safety (01.09.2016)
Get full text
Journal Article
Drug risk assessment and data reuse
Iyasu, Solomon, Staffa, Judy, Graham, Dave, Shoaibi, Azadeh, Levenson, Mark, Chakravarty, Aloka, Hammad, Tarek A.
Published in Pharmacoepidemiology and drug safety (01.01.2014)
Published in Pharmacoepidemiology and drug safety (01.01.2014)
Get full text
Journal Article
Regulatory Issues in use of Biomarkers in Oncology Trials
Chakravarty, Aloka G., Rothmann, Mark, Sridhara, Rajeshwari
Published in Statistics in biopharmaceutical research (01.11.2011)
Published in Statistics in biopharmaceutical research (01.11.2011)
Get full text
Journal Article