LTFU

About LTFU

The vision of the Long Term Follow Up (LTFU) Working Group is to create an international, open, harmonised and sustainable data registry with ACCELERATE to collect long term side effects of new anti-cancer therapies in children. This registry will help to Fulfill the regulatory requirements of the marketing authorisation holders & to Provide knowledge of the long term safety and follow up care of new modalities to support the best use of these therapies while providing important information for patients and families.
LFTU working group
Read publication: A global approach to long-term follow-up of targeted and immune-based therapy in childhood and adolescence

The working group was created to re-address the needs for long term follow-up, including existing gaps such as:

Limited inter-programme sharing as most long-term follow-up programmes are affiliated with a single academic institution in the USA and/or single country in the EU

Type and depth of data collected is heterogeneous between programmes


Companies only collect information on the small number of paediatric patients treated with their drug – limiting the evaluation and significance of uncommon toxicities;


Nomenclature differences between the Common Terminology Criteria for Adverse Events (CTCAE) and the Medical Dictionary for Regulatory Activities (MedDRA)

Adverse events of special interest not uniformly incorporated in current LTFU programmes.

Who we are

The LTFU WG is currently co-led by Dr Mark Kieran (Day One Biopharmaceuticals) & Danielle Horton Taylor (Pancare).

The Working group brings together representatives of three stakeholder groups:

 

Academia (clinicians and researchers):

Helena van der Pal (Pancare), Katrin Scheinemann (Pancare), Michael Hawkins (University of Birmingham), Lars Hjorth (Lund University), Riccardo Haupt (IRCCS Istituto G. Gaslini), Leontien Kremer (Pancare), Manuel Diezi (CHU Vaudois), Beth Fox (St. Jude), Monica Terenziani (Istituto Nazionale dei Tumori Milano), Michel Zwaan (Prinses Maxima), Holger Lode (Uniklinikum Greifswald), Roderick Skinner (Newcastle University), Eric Chow (University of Washington), Greg Armstrong (St. Jude), Jeanette Falck Winther (Danish Cancer registry) , Susan Chi (Dana Farber Cancer Institute), Tabitha Cooney (Dana Farber Cancer Institute), Melissa Hudson (St. Jude), Samuel Volchenboum (Chicago University), Monica Palese (Chicago University), Tara Henderson (Chicago University)


Industry (pharmaceutical companies and biotechs):

Hubert Carron (Roche), Leo Pereira (Roche), Yousif Matloub (Takeda), Laura Dima (Bayer), Azzeddine Zemam (EUSA Pharma), Jodi Muscal (Pfizer)


Advocacy (parents, patients and survivors):

Max Williamson (Teenage and Young Adult representative, National Cancer Research Institute), Susan Weiner (Children’s Cancer Cause), Nicole Scobie (Zoe4Life), Delphine Heenen (KickCancer)


For more information, please contact the working group lead:

LTFU Working Group Secretariat: andrea.demadonna@siope.eu

The 4 pillars

The Working group has gathered almost 30 experts representing academia, industry, patient advocates and regulators and it is co-chaired by Danielle Horton Taylor (PORT / PanCare) and Mark Kieran (BMS). Its work is carried out by four Sub-groups running in parallel and covering the four pillars of the initiative

LTFU Infrastructure
Infrastructure

What types of databases are compatible with academic LTF centers, can be used internationally, can be expanded

Data Elements
Data elements

What data elements are required

Governance LTFU
Governance

Location and management of the information

Sustainability LTFU
Sustainability

How to support this initiative going forward (finances, personnel)