Proposal for the development of biologics in pediatric rheumatology

Proposal for the development of biologics in pediatric rheumatology In order to assess the development, approval and early introduction into clinical practice of biologics in the pediatric field, we herein describe the current status of the development to approval of biologics as anti‐rheumatic agents for children in Japan, discuss the present problems and provide a proposal for the future. It has become apparent that the duration of the review period required for the preparation of clinical trials and Pharmaceuticals and Medical Devices Agency approval is clearly reduced compared with the past. Thus, it was speculated that a rate‐limiting step in the process from development to approval was the duration of clinical trials from start to end. Hence, we focused on the following key words with regard to promotion of the development of biologics and their early practical use: “registry”, “centralization”, and “global cooperation”, all of which are related to the reduction of duration of a clinical trial. In conclusion, to reduce the duration of a clinical trial, it is essential to complete a world‐scale registry system by developing the registry system established by the Pediatric Rheumatology Association of Japan. The next step is then to carefully plan to participate in the international network using the world‐scale registry system, and develop global cooperative trials in which we can ensure a sufficient number of entries from Japan. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Pediatrics International Wiley

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Publisher
Wiley Subscription Services, Inc., A Wiley Company
Copyright
Copyright © 2018 Japan Pediatric Society
ISSN
1328-8067
eISSN
1442-200X
D.O.I.
10.1111/ped.13495
Publisher site
See Article on Publisher Site

Abstract

In order to assess the development, approval and early introduction into clinical practice of biologics in the pediatric field, we herein describe the current status of the development to approval of biologics as anti‐rheumatic agents for children in Japan, discuss the present problems and provide a proposal for the future. It has become apparent that the duration of the review period required for the preparation of clinical trials and Pharmaceuticals and Medical Devices Agency approval is clearly reduced compared with the past. Thus, it was speculated that a rate‐limiting step in the process from development to approval was the duration of clinical trials from start to end. Hence, we focused on the following key words with regard to promotion of the development of biologics and their early practical use: “registry”, “centralization”, and “global cooperation”, all of which are related to the reduction of duration of a clinical trial. In conclusion, to reduce the duration of a clinical trial, it is essential to complete a world‐scale registry system by developing the registry system established by the Pediatric Rheumatology Association of Japan. The next step is then to carefully plan to participate in the international network using the world‐scale registry system, and develop global cooperative trials in which we can ensure a sufficient number of entries from Japan.

Journal

Pediatrics InternationalWiley

Published: Jan 1, 2018

Keywords: ; ; ; ;

References

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