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.
Bibliographical noteFunding Information:
In 2011, a programme of bi-annual paediatric oncology multi-stakeholder workshops was organised by the Cancer Drug Development Forum with the European ITCC consortium and the European Society for Paediatric Oncology (SIOP Europe), within the framework of an EU-funded project, the European Network for Cancer Research in Children and Adolescents (ENCCA). At the second workshop, the need for a multi-stakeholder platform was recognised to facilitate the timely and appropriate development of innovative drugs for children and adolescents with cancer. Thus, in 2016, the multi-stakeholder organisation ?ACCELERATE? was established as a transparent forum to discuss and address overarching issues in this critical space. The central premise of the platform was the involvement of the four stakeholder groups as equal partners and to facilitate the interaction between academia, industry, patient advocates and regulators; the phrase ?no blame, no shame? was adopted as a key principle. ACCELERATE's mission is patient-centred and problem-solving and aims to accelerate science-driven development of paediatric oncology drugs, facilitate international cooperation and collaboration between all stakeholders and improve early access to new anti-cancer drugs in development for children and adolescents. Very rapidly, the U.S. FDA joined the platform, and patient advocates and academics from around the world also became leading members of ACCELERATE.Andrew McDonough B+Foundation for financial support of ACCELERATE, EU funding through ENCCA and support from SIOPE and ITCC.
Andrew McDonough B+Foundation for financial support of ACCELERATE , EU funding through ENCCA and support from SIOPE and ITCC .
© 2022 The Author(s)
- Cancer therapeutics
- Drug development
- Paediatric oncology
PubMed: MeSH publication types
- Journal Article
- Research Support, Non-U.S. Gov't