Fit for Filing
Fit for Filing
About FFF
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 has been established by balancing the involvement of the relevant target groups: it includes 3 Academia, 3 Pharma, 2 Regulators and 1 Patient Advocate.
Who we are
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)
For more information, please contact the working group lead:
Fit for Filing Working Group Secretariat: carole.lecinse@gustaveroussy.fr
Objectives
Produce and publish best principles guidelines (define elements of a data package) for filing, roles and responsibilities in collaborative studies as well as resource needs to operationalise and deliver these types of trials.
Develop an education programme to disseminate the guidelines and support investigators and academic sponsors and industry collaborators to understand the needs for “fit for filing“ trials.
Supported by
