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Region Hovedstaden - en del af Københavns Universitetshospital
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ACCELERATE - Five years accelerating cancer drug development for children and adolescents

Publikation: Bidrag til tidsskriftReviewpeer review

DOI

  • Andrew D J Pearson
  • Susan L Weiner
  • Peter C Adamson
  • Dominik Karres
  • Gregory Reaman
  • Raphaël Rousseau
  • Patricia Blanc
  • Koen Norga
  • Jeffrey Skolnik
  • Pam Kearns
  • Nicole Scobie
  • Elly Barry
  • Lynley V Marshall
  • Leona Knox
  • Hubert Caron
  • Darshan Wariabharaj
  • Alberto Pappo
  • Steven G DuBois
  • Lia Gore
  • Mark Kieran
  • Brenda Weigel
  • Elizabeth Fox
  • Karsten Nysom
  • Teresa de Rojas
  • Gilles Vassal
Vis graf over relationer

Rapid evaluation and subsequent regulatory approval of new drugs are critical to improving survival and reducing long-term side-effects for children and adolescents with cancer. The international multi-stakeholder organisation ACCELERATE was created to advance the timely investigation of new anti-cancer drugs. ACCELERATE has enhanced communication and understanding between academia, industry, patient advocates and regulators. It has promoted a mechanism-of-action driven drug development approach and developed Paediatric Strategy Forums. These initiatives have facilitated prioritisation of medicinal products and a focused and sequential strategy for drug development where there are multiple potential agents. ACCELERATE has championed the early assessment of promising drugs in adolescents through their inclusion in adult early phase trials. ACCELERATE has strongly supported alignment between the European Medicines Agency and the US Food and Drug Administration and identification of unmet medical needs through multi-stakeholder collaboration. Early engagement between all stakeholders in the development of new drugs is critical. Innovative clinical trial designs are required, necessitating early discussion with sponsors and regulators. Amplifying the patient advocate voice through inclusion across the drug development continuum will lead to better, patient-centric trials. By these means, children and adolescents with cancer can maximally and rapidly benefit from innovative products to improve outcomes and reduce burdensome sequelae.

OriginalsprogEngelsk
TidsskriftEuropean journal of cancer (Oxford, England : 1990)
Vol/bind166
Sider (fra-til)145-164
Antal sider20
ISSN0959-8049
DOI
StatusUdgivet - maj 2022

Bibliografisk note

Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.

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