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.
Fit for Filling

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.
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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.
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