Aetion

A Case for Synthetic Data in Regulatory Decision-Making in Europe

Clinical Pharmacology & Therapeutics
Alloza, C., Knox, B., Raad, H., Aguilà, M., Coakley, C., Mohrova, Z., Boin, É., Bénard, M., Davies, J., Jacquot, E., Lecomte, C., Fabre, A. and Batech, M. (2023). https://doi.org/10.1002/cpt.3001

SURF: A Screening Tool (for Sponsors) to Evaluate Whether Using Real-World Data to Support an Effectiveness Claim in an FDA Application Has Regulatory Feasibility

Clinical Pharmacology & Therapeutics
Campbell, U.B., Honig, N. and Gatto, N.M. (2023). https://doi.org/10.1002/cpt.3021

Emulation of randomized clinical trials with nonrandomized database analyses: Results of 32 clinical trials.

Journal of the American Medical Association
Wang S, Schnessweiss S, RCT-DUPLICATE Initiative. doi:10.1001/jama.2023.4221.

Association of Remdesivir Treatment With Mortality Among Hospitalized Adults With COVID-19 in the United States

JAMA Network Open
Chokkalingam AP, Hayden J, Goldman JD, et al. 2022;5(12):e2244505. doi:10.1001/jamanetworkopen.2022.44505

Transferability of real-world data across borders for regulatory and health technology assessment decision-making

Frontiers in Medicine
Jaksa A, Arena PJ, Chan KKW, Ben-Joseph RH, Jónsson P and Campbell UB (2022) Front. Med. 9:1073678. doi: 10.3389/fmed.2022.1073678

Durability of the single-dose Ad26.COV2.S vaccine in the prevention of COVID-19 infections and hospitalizations in the US before and during the Delta variant surge.

JAMA Network Open
Polinski, JM, Weckstein AR, Batech M, Kabelac C, Kamath T, Haravey R, Jain S, Rassen JA, Khan N, Schneeweiss S 2022. doi:10.1001/jamanetworkopen.2022.2959.

Treatment transitions in chronic obstructive pulmonary disease: retrospective analyses of US and UK healthcare databases.

Pulmonary Therapy
Bloom CI, Montonen J, Jöns O, Garry EM, Bhatt SP 2021. doi: 10.1007/s41030-021-00180-7.

First maintenance therapy for chronic obstructive pulmonary disease: retrospective analyses of US and UK healthcare databases.

Pulmonary Therapy
Bloom CI, Montonen J, Jöns O, Garry EM, Bhatt SP 2021. doi: 10.1007/s41030-021-00179-0.

The role of real-world evidence in FDA-approved new drug and biologics license applications.

Clinical Pharmacology & Therapeutics
Purpura CA, Garry EM, Honig N, Case A, Rassen JA 2021. doi:10.1002/cpt.2474.

The Structured Process to Identify Fit-For-Purpose Data: A data feasibility assessment framework.

Clinical Pharmacology & Therapeutics
Gatto NM, Campbell UB, Rubinstein E, Jaksa A, Mattox P, Mo J, Reynolds RF 2021. doi:10.1002/cpt.2466.
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