CFPs: Investigator-Initiated Multinational Clinical Trials for Paediatric Cancer

Deadline: 16-Sep-25

Applications are now open for the Investigator-Initiated Multinational Early-Stage Innovative Clinical Trials for Paediatric Cancer Program.

Scope

• This topic will contribute to the achievement of the Mission’s objective to provide better treatments for cancer. The focus is on children (0-14 years of age, e.g. age of first cancer diagnosis) and/or adolescent (15-19 years of age, e.g. age of first cancer diagnosis) cancer patients.
• Paediatric oncology has made considerable progress, increasing patient survival rates up to 80%; yet cancer remains the leading cause of death in children and adolescents. Progress in R&I to support the development of targeted cancer treatments for children has been rather limited. Over the past 20 years, less than 10% of new anti-cancer drugs have received marketing authorization for paediatric use, resulting in limited availability of innovative therapies to treat paediatric cancers. This is even more striking when cancers with poor prognosis are considered.
• Most of the treatments currently used for paediatric cancers have been developed to treat adult cancers; in addition, young cancer patients and survivors very often experience adverse late-effectsdue to the high toxicity of treatments. Clinical tools used to evaluate treatment outcomes (e.g. tools to assess toxicity, radiological response, quality of life etc.), are also derived from adult oncology and therefore suboptimal;
• This situation mostly reflects the fact that paediatric cancers are rare, and their biology is different to adult cancers. The relatively low number of cases warrants the implementation of multinational academic-initiated clinical trials to accelerate the development of innovative, more effective and less toxic treatments.

Funding Information

• The check will normally be done for the coordinator if the requested grant amount is equal to or greater than EUR 500 000, except for:
  • public bodies (entities established as a public body under national law, including local, regional or national authorities) or international organisations; and
  • cases where the individual requested grant amount is not more than EUR 60 000 (low value grant).

Eligible Activities

• The following activities are generally eligible for grants under Horizon Europe:
  • Research and innovation actions (RIA) — Activities that aim primarily to establish new knowledge or to explore the feasibility of a new or improved technology, product, process, service or solution. This may include basic and applied research, technology development and integration, testing, demonstration and validation of a small-scale prototype in a laboratory or simulated environment.
  • Innovation actions (IA) — Activities that aim directly to produce plans and arrangements or designs for new, altered or improved products, processes or services. These activities may include prototyping, testing, demonstrating, piloting, large-scale product validation and market replication.
  • Coordination and support actions (CSA) — Activities that contribute to the objectives of Horizon Europe. This excludes research and innovation (R&I) activities, except those carried out under the ‘Widening participation and spreading excellence’ component of the programme (part of ‘Widening participation and strengthening the European Research Area’). Also eligible are bottom-up coordination actions which promote cooperation between legal entities from Member States and Associated Countries to strengthen the European Research Area, and which receive no EU co-funding for research activities.
  • Programme co-fund actions (CoFund) — A programme of activities established or implemented by legal entities managing or funding R&I programmes, other than EU funding bodies. Such a programme of activities may support: networking and coordination; research; innovation; pilot actions; innovation and market deployment; training and mobility; awareness raising and communication; and dissemination and exploitation. It may also provide any relevant financial support, such as grants, prizes and procurement, as well as Horizon Europe blended finance 30 or a combination thereof.

Expected Outcomes

• Proposals under this topic should aim to deliver results that are directed and tailored towards and contribute to all of the following expected outcomes:
  • Children and adolescents with cancer have access to innovative, more effective, less toxic treatments–both in terms of acute toxicity and long-term late effects–and care solutions;
  • National healthcare providers, policymakers and authorities in European regions, Member States and Associated Countries have the scientific evidence to accelerate the implementation of affordable and accessible treatment and care solutions in their healthcare systems;
  • Researchers, innovators, and professionals from different disciplines and sectors ensure accessibility and re-usability of relevant trial data, to support the future UNCAN.eu research data platform, which is currently in preparation.

Eligibility Criteria

• Any legal entity, regardless of its place of establishment, including legal entities from no associated third countries or international organisations (including international European research organisations) is eligible to participate.
• A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.
• Specific cases:
  • Affiliated entities — Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
  • Associated partners — Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any specific call/topic conditions.
  • Entities without legal personality — Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees to protect the EU’s financial interests equivalent to those offered by legal persons.
  • EU bodies — Legal entities created under EU law including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
• To be eligible for funding, applicants must be established in one of the following countries:
  • the Member States of the European Union, including their outermost regions:
    • Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden.
  • the Overseas Countries and Territories (OCTs) linked to the Member States:
    • Aruba (NL), Bonaire (NL), Curação (NL), French Polynesia (FR), French Southern and Antarctic Territories (FR), Greenland (DK), New Caledonia (FR), Saba (NL), Saint Barthélemy (FR), Sint Eustatius (NL), Sint Maarten (NL), St. Pierre and Miquelon (FR), Wallis and Futuna Islands (FR).
  • countries associated to Horizon Europe
    • Albania, Armenia, Bosnia and Herzegovina, Canada, Faroe Islands, Georgia, Iceland, Israel, Kosovo, Moldova, Montenegro, New Zealand, North Macedonia, Norway, Serbia, Tunisia, Türkiye, Ukraine, United Kingdom.

For more information, visit EC.