Practical issues and lessons learned from multi-regional clinical trials via case examples: a Japanese perspective

2010 ◽  
Vol 9 (3) ◽  
pp. 190-200 ◽  
Author(s):  
Yuki Ando ◽  
Toshimitsu Hamasaki
Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aldo Badano

AbstractImaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availability. Here, I describe some of the principal advantages of in silico imaging trials and enumerate five lessons learned during the design and execution of the first all-in silico virtual imaging clinical trial for regulatory evaluation (the VICTRE study).


Materials ◽  
2021 ◽  
Vol 14 (4) ◽  
pp. 706
Author(s):  
Irene Rubia-Rodríguez ◽  
Antonio Santana-Otero ◽  
Simo Spassov ◽  
Etelka Tombácz ◽  
Christer Johansson ◽  
...  

The scientific community has made great efforts in advancing magnetic hyperthermia for the last two decades after going through a sizeable research lapse from its establishment. All the progress made in various topics ranging from nanoparticle synthesis to biocompatibilization and in vivo testing have been seeking to push the forefront towards some new clinical trials. As many, they did not go at the expected pace. Today, fruitful international cooperation and the wisdom gain after a careful analysis of the lessons learned from seminal clinical trials allow us to have a future with better guarantees for a more definitive takeoff of this genuine nanotherapy against cancer. Deliberately giving prominence to a number of critical aspects, this opinion review offers a blend of state-of-the-art hints and glimpses into the future of the therapy, considering the expected evolution of science and technology behind magnetic hyperthermia.


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Neema Toto ◽  
Elaine Douglas ◽  
Markus Gmeiner ◽  
Lynn K. Barrett ◽  
Robert Lindblad ◽  
...  

2005 ◽  
Vol 6 (4) ◽  
pp. 240-244 ◽  
Author(s):  
Michael A Papagikos ◽  
Edward G Shaw ◽  
Volker W Stieber

2021 ◽  
pp. 55-61
Author(s):  
Rose M. Ylimaki ◽  
Lynnette A. Brunderman

AbstractThis chapter presents our approach to building and sustaining leadership capacity with attention to three areas: (1) personal capacity and commitment to growth; (2) interactions and interpersonal capacity grounded in a culture of trust, collective responsibility and appreciation of diversity, and (3) organizational capacity in high functioning teams that take responsibility for a child-centered vision and help diffuse that vision throughout the school. Leadership in high capacity schools incorporates both formal and informal leadership capacities (Mitchell and Sackney, 2009). Team leadership is essential for building and sustaining leadership capacity in a shared direction for continous school development and diffusion of educational improvements throughout the school. As formal leaders leave to take on new positions in the district or elsewhere, the shared direction and culture of continous improvement helps to sustain progress. In this chapter, we discuss our experiences with building and sustaining leadership capacity in teams that work to develop and diffuse a shared direction for continuous school development. We begin with a discussion of the research-based content from ISSPP and other studies that informed our project. The balance of the chapter presents application in our research-practice approach in the Arizona project (AZILDR) as well as lessons learned with case examples.


2000 ◽  
Vol 5 (3) ◽  
pp. 249-254 ◽  
Author(s):  
Bernard Charpentier ◽  
Christian Hiesse ◽  
Antoine Durrbach ◽  
Mounia Ammor ◽  
Frederike Von Ey ◽  
...  

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