The Fit for Filing Group at ACCELERATE
November 14, 2022 CAC2 Blog Posts, Community News, Guest Blogs, Research Explained
Blogged with permission and thanks by the ACCELERATE Fit for Filing Working Group
The ACCELERATE PLATFORM’S Fit for Filing (FFF) group was formed in 2019 to explore the issues of academic-led trials that typically do not produce data that is fit-for-filing to gain marketing approval by regulatory agencies.
The scope of Fit for Filing (FFF) is to develop best principles on how to design and deliver an academic or academic & industry collaborative trial with a dataset that can be included in a package for regulatory filing.Objectives of the FFF working group are:
- Define the barriers and propose solutions to ensure academic trial datasets are usable for regulatory submissions;
Define how industry can support academic/healthcare institutions to deliver fit for filing clinical trials.
- The Working Group was established by balancing the involvement of the relevant target groups: it includes 3 Academia, 3 Pharma, 2 Regulators and 1 Patient Advocate.
The Fit For Filing WG is currently co-led by Prof. Pam Kearns (University of Birmingham) & Elly Barry (Day One Biopharmaceuticals).
The Working group brings together representatives of four stakeholder groups:
Academia (clinicians and researchers): Bram De Wilde (Ghent University Hospital), Beth Fox (Children’s Hospital Philadelphia)
Regulators: Greg Reaman (FDA), Dominik Karres (EMA)
Industry (pharmaceutical companies and biotechs): Elly Barry (Day One Biopharmaceuticals), Mark Kieran (Day One Biopharmaceuticals)
Advocacy (parents, patients and survivors): Donna Ludwinski (Solving Kids’ Cancer)
The FFF group produced and published best principles guidelines for filing, roles and responsibilities in collaborative studies as well as resource needs to operationalize and deliver these types of trials. Click here to access the guidelines.
Following this, FFF developed an education programme in 2022 to disseminate the guidelines and support investigators and academic sponsors and industry collaborators to understand the needs for “fit for filing“ trials.
The programme was split in three webinars now available for viewing (click webinar titles below to view):
- Should and could my trial be fit for filing
- A spoonful of data helps the medicine go down: Purposeful collection of clean and reproducible trial data
- With great trial needs comes great responsibilities: Delivering high quality data and successfully file an application (forthcoming)
This paper and education series is particularly important to help advocates and charities funding clinical trials understand and promote fit-for-filing trials so that access to successful agents is ultimately available to children after a trial is closed.
More about the ACCELERATE Platform:
ACCELERATE is breaking the silo mentality sometimes existing among the four essential stakeholders in childhood cancer drug development. They bring academic researchers, industry representatives, parents and patient advocates, and regulators to discuss innovative treatments for children and adolescents with cancer. All of these stakeholders have an equal voice within the organization.
ACCELERATE promotes a problem-solving dynamic where all stakeholders work together to identify issues and find solutions. Patients are always at the heart of their work. Establishing an action plan with definite goals is the main objective.
ACCELERATE actively explores and researches into specific paediatric oncology challenges and proposes solutions through its Working Groups. Working Groups are composed of representatives of all the 4 stakeholders plus additional external stakeholders on ad-hoc basis. The work performed and the results achieved by the ACCELERATE platform working groups are published in peer reviewed journals.
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