European regulatory strategy for supporting childhood cancer therapy developments
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00159816%3A_____%2F22%3A00076495" target="_blank" >RIV/00159816:_____/22:00076495 - isvavai.cz</a>
Alternative codes found
RIV/65269705:_____/22:00076495 RIV/00216224:14110/22:00128435
Result on the web
<a href="https://www.sciencedirect.com/science/article/pii/S0959804922007651?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S0959804922007651?via%3Dihub</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.ejca.2022.09.025" target="_blank" >10.1016/j.ejca.2022.09.025</a>
Alternative languages
Result language
angličtina
Original language name
European regulatory strategy for supporting childhood cancer therapy developments
Original language description
Introduction: Regulatory decisions on paediatric investigation plans (PIPs) aim at making effective and safe medicines timely available for children with high unmet medical need. At the same time, scientific knowledge progresses continuously leading frequently to the identification of new molecular targets in the therapeutic area of oncology. This, together with further efforts to optimise next generation medicines, results in novel innovative products in development pipelines. In the context of global regulatory development requirements for these growing pipelines of innovative products (e.g. US RACE for children Act), it is an increasing challenge to complete development efforts in paediatric oncology, a therapeutic area of rare and life-threatening diseases with high unmet needs.Objective: Regulators recognise feasibility challenges of the regulatory obligations in this context. Here, we explain the EU regulatory decision making strategy applied to paediatric oncology, which aims fostering evidence generation to support developments based on needs and robust science. Because there is a plethora of products under development within given classes of or within cancer types, priorities need to be identified and updated as evidence evolves. This also includes identifying the need for third or fourth generation products to secure focused and accelerated drug development.Conclusion: An agreed PIP, as a plan, is a living document which can be modified in light of new evidence. For this to be successful, input from the various relevant stakeholders, i.e. pa-tients/parents, clinicians and investigators is required.
Czech name
—
Czech description
—
Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
—
OECD FORD branch
30204 - Oncology
Result continuities
Project
—
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2022
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
European Journal of Cancer
ISSN
0959-8049
e-ISSN
1879-0852
Volume of the periodical
177
Issue of the periodical within the volume
Dec
Country of publishing house
US - UNITED STATES
Number of pages
5
Pages from-to
25-29
UT code for WoS article
000879879800003
EID of the result in the Scopus database
2-s2.0-85141834667