scholarly journals State of the Art: Use of Real‐World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design

2021 ◽  
Author(s):  
Simon Dagenais ◽  
Leo Russo ◽  
Ann Madsen ◽  
Jen Webster ◽  
Lauren Becnel
Keyword(s):  
Clinical Trial ◽  
Drug Development ◽  
Development Strategy ◽  
Real World ◽  
Trial Design ◽  
State Of The Art ◽  
Clinical Trial Design ◽  
Real World Evidence

The future of drug development: advancing clinical trial design

2009 ◽  
Vol 8 (12) ◽  
pp. 949-957 ◽  
Author(s):  
John Orloff ◽  
Frank Douglas ◽  
Jose Pinheiro ◽  
Susan Levinson ◽  
Michael Branson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Drug Development ◽  
Trial Design ◽  
Clinical Trial Design ◽  
The Future

scholarly journals Drug development and clinical trial design in pancreatico-biliary malignancies

2018 ◽  
Vol 42 (1) ◽  
pp. 73-94 ◽  
Author(s):  
Jennifer Harrington ◽  
Louise Carter ◽  
Bristi Basu ◽  
Natalie Cook
Keyword(s):  
Clinical Trial ◽  
Drug Development ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Biliary Malignancies

scholarly journals Regulatory-grade clinical trial design using real-world data

2020 ◽  
Vol 17 (4) ◽  
pp. 377-382
Author(s):  
Mark S Levenson
Keyword(s):  
Real World ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Real World Data ◽  
World Data ◽  
Real World Evidence ◽  
Study Results ◽  
Potential Use ◽  
The U.S

Real-world data and evidence provide the potential to address the effectiveness and safety of drugs. The U.S. Food & Drug Administration has initiated a program to evaluate the potential use of real-world evidence for regulatory uses. Whether a study is designed for regulatory purposes or for other purposes, existing regulation and guidance provide a reference for high-quality studies. Clarifying the study objectives and the role of real-world data in the study are important considerations. Robustness and transparency of the analysis allow for greater understanding and acceptance of the study results.

scholarly journals Trial Design and Efficacy Thresholds for Granting Breakthrough Therapy Designation in Oncology

2016 ◽  
Vol 12 (8) ◽  
pp. e810-e817 ◽  
Author(s):  
Kenneth A. Kern
Keyword(s):  
Clinical Trial ◽  
Drug Development ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Molecular Entity ◽  
Development Programs ◽  
Key Factors ◽  
Us Congress ◽  
Oncology Research ◽  
The Us

Breakthrough therapy designation (BTD) is a new approach created by the US Congress and the US Food and Drug Administration (FDA) as part of the FDA Innovation and Safety Act of 2012 to expedite the drug development process for serious illness, including cancer. By law, to qualify for BTD, a new molecular entity must demonstrate substantial clinical improvement over existing therapies. Although the administrative requirements for granting BTD have been made available by the FDA, the actual trial designs, end points, and quantitative therapeutic thresholds involved in the granting process have not been made public. This literature review evaluates nine oncology new molecular entities granted BTD involved in 10 accelerated approvals and summarizes the key factors in clinical trial design leading to successful BTD applications. This information can be used by oncology research teams to set goals for BTD when developing clinical trial designs and thresholds in expedited drug development programs.

scholarly journals Phase I–II clinical trial design: a state-of-the-art paradigm for dose finding

2018 ◽  
Vol 29 (3) ◽  
pp. 694-699 ◽  
Author(s):  
F. Yan ◽  
P.F. Thall ◽  
K.H. Lu ◽  
M.R. Gilbert ◽  
Y. Yuan
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Trial Design ◽  
State Of The Art ◽  
Clinical Trial Design ◽  
Dose Finding
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