Clinical development of combination strategies in immunotherapy: are we ready for more than one investigational product in an early clinical trial?

Immunotherapy ◽  
2009 ◽  
Vol 1 (5) ◽  
pp. 845-853 ◽  
Author(s):  
Jose L Perez-Gracia ◽  
Pedro Berraondo ◽  
Ivan Martinez-Forero ◽  
Carlos Alfaro ◽  
Natalia Suarez ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Development ◽  
Investigational Product ◽  
Early Clinical Trial ◽  
Combination Strategies

scholarly journals Early clinical trial data and real‐world assessment of COVID‐19 vaccines: Insights from the Society of Infectious Diseases Pharmacists

2021 ◽  
Vol 41 (10) ◽  
pp. 837-850
Author(s):  
Nimish Patel ◽  
Jeannette Bouchard ◽  
Meredith B. Oliver ◽  
Melissa E. Badowski ◽  
Joseph J. Carreno ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Infectious Diseases ◽  
Real World ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Early Clinical Trial

scholarly journals Adaptation in clinical development plans and adaptive clinical trial designs

2012 ◽  
Vol 5 (4) ◽  
pp. 431-442 ◽  
Author(s):  
Tze Leung Lai ◽  
Olivia Yueh-Wen Liao ◽  
Ray Guangrui Zhu
Keyword(s):  
Clinical Trial ◽  
Clinical Development ◽  
Development Plans ◽  
Clinical Trial Designs

scholarly journals Edaravone in Amyotrophic Lateral Sclerosis’Lessons from the Clinical Development Program and the Importance of a Strategic Clinical Trial Design

US Neurology ◽  
2018 ◽  
Vol 14 (1) ◽  
pp. 47 ◽  
Author(s):  
Said R Beydoun ◽  
Jeffrey Rosenfeld
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Amyotrophic Lateral Sclerosis ◽  
Trial Design ◽  
Development Program ◽  
Clinical Trial Design ◽  
Clinical Development ◽  
Disease Heterogeneity ◽  
Clinical Development Program ◽  
Lateral Sclerosis

Edaravone significantly slows progression of amyotrophic lateral sclerosis (ALS), and is the first therapy to receive approval by the Food and Drug Administration (FDA) for the disease in 22 years. Approval of edaravone has marked a new chapter in pharmaceutical development since the key trial included a novel strategic clinical design involving cohort enrichment. In addition, approval was based on clinical trials that had a relatively small patient number and were performed outside of the US. Edaravone was developed through a series of clinical trials in Japan where it was determined that a well-defined subgroup of patients was required to reveal a treatment effect within the study period. Amyotrophic lateral sclerosis is associated with wide-ranging disease heterogeneity (both within the spectrum of ALS phenotypes as well as in the rate of progression). The patient cohort enrichment strategy aimed to address this heterogeneity and should now be considered as a viable, and perhaps preferred, trial design for future studies. Future research incorporating relevant biomarkers may help to better elucidate edaravone’s mechanism of action, pharmacodynamics, and subsequently ALS phenotypes that may preferentially benefit from treatment. In this review, we discuss the edaravone clinical development program, outline the strategic clinical trial design, and highlight important lessons for future trials.

scholarly journals Use of Early Clinical Trial Data to Support Thorough QT Study Waiver for Upadacitinib and Utility of Food Effect to Demonstrate ECG Assay Sensitivity

2017 ◽  
Vol 103 (5) ◽  
pp. 836-842 ◽  
Author(s):  
Mohamed-Eslam F. Mohamed ◽  
Jiewei Zeng ◽  
Ping Jiang ◽  
Balakrishna Hosmane ◽  
Ahmed A. Othman
Keyword(s):  
Clinical Trial ◽  
Food Effect ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Assay Sensitivity ◽  
Early Clinical Trial ◽  
Thorough Qt Study
Sign in / Sign up

Export Citation Format

Share Document