Publications
The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020. Int J Cancer. 2023 Jun 15;152(12):2474-2484
Gloy V., Schmitt A.M., Düblin P., Hirt J., Axfors C., Kuk H., Pereira T.V., Locher C., Caquelin L., Walter-Claudi M., Lythgoe M.P., Herbrand A., Kasenda B., Hemkens L.G., 2023
Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016. JAMA Netw Open 3, e2024406.
Ladanie, A., Schmitt, A. M., Speich, B., Naudet, F., Agarwal, A., Pereira, T. V., Sclafani, F., Herbrand, A. K., Briel, M., Martin-Liberal, J., Schmid, T., Ewald, H., Ioannidis, J. P. A., Bucher, H. C., Kasenda, B. & Hemkens, L. G., 2020.
How to use FDA drug approval documents for evidence syntheses
BMJ 362, k2815
Ladanie, A., Ewald, H., Kasenda, B., Hemkens, L.G., 2018.
The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs. Trials 19, 505.
Ladanie, A., Speich, B., Naudet, F., Agarwal, A., Pereira, T.V., Sclafani, F., Martin-Liberal, J., Schmid, T., Ewald, H., Ioannidis, J.P.A., Bucher, H.C., Kasenda, B., Hemkens, L.G., 2018.
Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies. J. Clin. Epidemiol. 114, 49–59.
Ladanie, A., Speich, B., Briel, M., Sclafani, F., Bucher, H.C., Agarwal, A., Ioannidis, J.P.A., Pereira, T.V., Kasenda, B., Hemkens, L.G., 2019.