scholarly journals Efficacy and safety of tafluprost 0.0015% – retrospective analysis of real-world data from the Philippines

2019 ◽  
Vol Volume 13 ◽  
pp. 1627-1634 ◽  
Author(s):  
Joseph Anthony Tumbocon ◽  
Anne Marie Macasaet
Keyword(s):  
Retrospective Analysis ◽  
Real World ◽  
The Philippines ◽  
Efficacy And Safety ◽  
Real World Data ◽  
World Data

scholarly journals Application of Real-World Data to External Control Groups in Oncology Clinical Trial Drug Development

2022 ◽  
Vol 11 ◽  
Author(s):  
Timothy A. Yap ◽  
Ira Jacobs ◽  
Elodie Baumfeld Andre ◽  
Lauren J. Lee ◽  
Darrin Beaupre ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Real World ◽  
External Control ◽  
Control Group ◽  
Precision Oncology ◽  
Efficacy And Safety ◽  
Control Groups ◽  
Real World Data ◽  
World Data

Randomized controlled trials (RCTs) that assess overall survival are considered the “gold standard” when evaluating the efficacy and safety of a new oncology intervention. However, single-arm trials that use surrogate endpoints (e.g., objective response rate or duration of response) to evaluate clinical benefit have become the basis for accelerated or breakthrough regulatory approval of precision oncology drugs for cases where the target and research populations are relatively small. Interpretation of efficacy in single-arm trials can be challenging because such studies lack a standard-of-care comparator arm. Although an external control group can be based on data from other clinical trials, using an external control group based on data collected outside of a trial may not only offer an alternative to both RCTs and uncontrolled single-arm trials, but it may also help improve decision-making by study sponsors or regulatory authorities. Hence, leveraging real-world data (RWD) to construct external control arms in clinical trials that investigate the efficacy and safety of drug interventions in oncology has become a topic of interest. Herein, we review the benefits and challenges associated with the use of RWD to construct external control groups, and the relevance of RWD to early oncology drug development.

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