Detalhe da pesquisa
1.
Trial designs using real-world data: The changing landscape of the regulatory approval process.
Pharmacoepidemiol Drug Saf
; 29(10): 1201-1212, 2020 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-31823482
2.
The Current Landscape and Emerging Applications for Real-World Data in Diagnostics and Clinical Decision Support and its Impact on Regulatory Decision Making.
Clin Pharmacol Ther
; 112(6): 1172-1182, 2022 12.
Artigo
em Inglês
| MEDLINE | ID: mdl-35213741
3.
Application of Real-World Data to External Control Groups in Oncology Clinical Trial Drug Development.
Front Oncol
; 11: 695936, 2021.
Artigo
em Inglês
| MEDLINE | ID: mdl-35070951
4.
Use of Real-World Data to Emulate a Clinical Trial and Support Regulatory Decision Making: Assessing the Impact of Temporality, Comparator Choice, and Method of Adjustment.
Clin Pharmacol Ther
; 109(2): 452-461, 2021 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-32767673
5.
Defining Clinically Relevant Target Populations Using Real-World Data to Guide the Design of Representative Antidiabetic Drug Trials.
Clin Pharmacol Ther
; 109(5): 1219-1223, 2021 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-33615445
6.
Overcoming Regulatory Aversion to Novel Methods of Evidence Generation.
Clin Pharmacol Ther
; 107(5): 1057-1058, 2020 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-31785161