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 The Future of Clinical Trial Design in Oncology

2021 ◽  
Vol 11 (4) ◽  
pp. 822-837
Author(s):  
Anna Spreafico ◽  
Aaron R. Hansen ◽  
Albiruni R. Abdul Razak ◽  
Philippe L. Bedard ◽  
Lillian L. Siu
Keyword(s):  
Clinical Trial ◽  
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 Discovery of human ACE2 variants with altered recognition by the SARS-CoV-2 spike protein

PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0251585
Author(s):  
Pete Heinzelman ◽  
Philip A. Romero
Keyword(s):  
Clinical Trial ◽  
Genetic Variants ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Spike Protein ◽  
Single Nucleotide Variants ◽  
Single Nucleotide ◽  
Novel Variants ◽  
The Future ◽  
Fundamental Research

Understanding how human ACE2 genetic variants differ in their recognition by SARS-CoV-2 can facilitate the leveraging of ACE2 as an axis for treating and preventing COVID-19. In this work, we experimentally interrogate thousands of ACE2 mutants to identify over one hundred human single-nucleotide variants (SNVs) that are likely to have altered recognition by the virus, and make the complementary discovery that ACE2 residues distant from the spike interface influence the ACE2-spike interaction. These findings illuminate new links between ACE2 sequence and spike recognition, and could find substantial utility in further fundamental research that augments epidemiological analyses and clinical trial design in the contexts of both existing strains of SARS-CoV-2 and novel variants that may arise in the future.

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.

Sign in / Sign up

Export Citation Format

Share Document