FAIR trials

FAIR TRIALS

Why FAIR trials

Research into teenage and young adults’ cancer has made slower progress than for any other age group. One reason is that many clinical trials exclude patients under 18 – without medical justification.

To confront this problem, the Working Group on Fostering Age Inclusive Research (or FAIR Trials) was established in 2017 by the ACCELERATE Forum. Made up of 15 experts from Academia, Industry and Parents/Patients advocacy, the group aims to raise awareness and promote change.

We propose a six-point approach in order to improve access for adolescents to new anti-cancer drugs and to make the drug development process more efficient. Read more about the six-point approach here.

Positions open!


Would you like to join the ACCELERATE FAIR Working Group? We are currently looking for:

  • Medical Oncologists
  • Patient and Parent Advocates

Get in touch with us!

Whether you work in Pharma, Research, Ethics or as a Patient Advocate, join our circle of supporters so that we can share expertise and experience.


Push the arguments in your own networks. Patient advocates are often consulted on the planning of research trials and these are ideal opportunities to bring the issues to the table.

 

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Fair for Aya Stamps
FAIR for AYA stamp

Four clinical trials in oncology have been awarded the FAIR for AYA STAMP, a new accolade that credits medical research which actively avoids unnecessary barriers based on age. It is hoped that the STAMP will encourage other researchers to offer opportunities for adolescents and young adults to participate in trials.


What is the objective?

The FAIR Trials initiative aims to accelerate innovation in drug development for young people with cancer, through the removal of arbitrary age limits in clinical trials.

To facilitate this, ACCELERATE is offering a ‘Stamp’ for trials which actively avoid unnecessary barriers based on the age of participants. Applications are invited from sponsors of multinational trials compatible with our six proposals – specifically, adult early phase trials offering adolescent accrual or paediatric trials with accrual for young adults.


Benefits


The FAIR for AYA Stamp can be used for publicity purposes and can feature on trial protocols, clinical trial applications or other associated documents, as well as  academic publications. Trials which have received the Stamp will appear on the ACCELERATE website and may be used in other ACCELERATE media as exemplars for the research community.


Limitations


The scheme does not provide an overall scientific review of the trial. It only evaluates the study design elements that relate to age inclusivity. It refers specifically to a particular trial, not the organisations or individuals involved or any other activities in which they are engaged.


Procedure


Applicants should complete the application form (click on ‘Open the Form’ below). Please send all trial documents necessary to substantiate study design elements that facilitate the inclusion of young people with cancer. 


Examples include:

  • Final study protocol & appendices (including assent forms)
  • EudraCT posting (with link provided)
  • gov posting (with link provided)
  • Electronic Case Report Form

These supporting documents should be sent to:


Carole LECINSE

ITCC Project Manager

carole.lecinse@gustaveroussy.fr


The reviewers will aim to give a reply within 6 weeks of the submission of an application.
Apply now List of FAIR for AYA Stamps
E-Learning Tools
E-learning

Take a look at the ESMO-SIOPE E-Learning tool Improving AYA Access To Innovative Therapies by Breaking the 18 Years Dogma.


Learning Objectives

  1. To raise awareness about needs for new drugs for haemato-oncology treatment in adolescents and young adults.
  2. To provide an overview of the European regulation and current landscape in the drug development and early drug access in the adolescent and young adult population.
  3. To provide an overview of proposed changes in trial strategy for adolescents and young adults, from early drug development to accelerate AYA access to the therapeutic innovation, by the FAIR (Fostering Age Inclusive Research) trial group of the multi-stakeholder European Paediatric Platform ACCELERATE.



Find out more
Survey on early phase trials
Survey on early phase trials (phase I/II) for adolescents and young adults with cancer

Are you part of academia, industry or health authorities? Have you experienced potential hurdles associated with inclusive early phase trials in the field of new drug development? The FAIR Group survey is just designed for you! 

 

Our goal is to encourage access of adolescent and young adults (AYA) into adult phase I/II innovative trials where appropriate based on the disease or mechanism of action of the drug but also access of young adults (>18) into paediatric early phase trials, especially when their diagnosis is a ‘paediatric’ type cancer.


Take survey

Publications

FAIR Group publications

publications

Joint adolescent–adult early phase clinical trials to improve access to new drugs for adolescents with cancer: proposals from the multi-stakeholder platform—ACCELERATE

Gaspar, N. et al. (2018)

Annals of Oncology

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FAIR trials for Adolescents & Young Adults Scientific publications

publications

Ease the Age Barrier That Keeps Young Cancer Patients Out of Trials. Applied Clinical Trials

O’Donnell, P., Feb.2020. 

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publications
publications

The 18-year-old clinical trial inclusion limit is a major barrier in the access to immunotherapies and targeted therapies for adolescents and young adults (AYAs) with cancer.

De Rojas, T., Neven, A., Garcia-Abos, M., Moreno, L., Gaspar, N., & Peron, J. 2019. Annals Of Oncology, 30 (Supplement_1) 

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FAIR trials for Adolescents & Young Adults in Mainstream media

publications

SIOPE Press Release (2020)

Teenagers with cancer set to benefit from international initiative aimed at lowering the age of participation to potentially life-saving treatments

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ASCO Post (2019)

AYA Survivors Should Be Allowed to Participate in Adult Clinical Trials

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Who we are

The FAIR WG is currently co-led by Nathalie Gaspar & Max Williamson.


The Working group brings together representatives of four stakeholder groups:

 

Academia (clinicians and researchers):

Martin Elliott, Leeds University

Nathalie Gaspar (co-Chair), Gustave Roussy

Lynley Marshall, Royal Marsden

Elizabeth Corley, Royal Marsden

Julia Glade Bender, MSKCC

Cristina Larrosa, Sant Joan de Deu

Aditi Vedi, Addenbrookes Cambridge (UK)

Claudia Valverde Morales, Vall d’Hebron University Hospital - Medical Oncologist

Viswatej Avutu, MSKCC - Medical Oncologist


Industry (pharmaceutical companies and biotechs):

Christina Buccirechtweg, Novartis

Solange Corriol-Rohou, AstraZeneca

Evgenia Mengou, EV Pharma Solutions Ltd.

Mark Kieran, Day One

Stergios Zacharoulis, BMS

Gabriele Bieska, Roche

Brian Friend, Astellas Pharma Inc.


Advocacy (parents, patients and survivors):

Max Williamson

Ana Amariutei

Deanna Fournier

Ann Graham

Julie Guillot

Menia Koukougianni, KARKINAKI (Greece)


For more information, please contact the working group lead:

FAIR Working Group Secretariat: Carole Lecinse carole.lecinse@gustaveroussy.fr

Chris Copland

Chris Copland – Parent Representative

Clinical trials offer hope that one day we may save the thousands of young lives we lose to cancer every year in Europe alone. However, currently, many trials exclude patients under eighteen, though this age limit bears little relation to science, safety or compassion.


What are the consequences?

Delays. New treatments for conditions like lymphoma, only become available to adolescents years after they have been authorised for adults.

Ghost trials. Research into rare conditions becomes untenable because it is limited to a narrow age group, as has been the case with melanoma.


Ten years ago, my teenage daughter, Bethan, relapsed with an advanced form of cancer for which there was no effective treatment. In the final year of her life, not a single, relevant clinical trial was available for her to join. Sadly, this situation has changed little in the intervening years.


It is vital that more clinical trials are offered to young people and one immediate way we could do this is by removing arbitrary age limits. This is why I fight for FAIR Trials and why I ask you to join me.
Nathalie Gaspar

Nathalie Gaspar – Gustave Roussy

As a paediatric oncologist, my main fear is of missing an opportunity that might benefit my patients by giving them a chance of either cure or control their disease. A patient with cancer not being able to access a trial just because he/she is under 18 has become unbearable.

 

I have listened to adolescents telling me, “Why have you prescribed this drug to my mate of 19 years old and you are telling me that I cannot have access to this drug without travelling miles away?”



“It will be too late for me if I have to wait for my 18th birthday to participate in this trial. It is in 5 months’ time. What can you do for me to get the drug?”


Parents echo their children’s thoughts too: “This is unfair. Just because of a silly age inclusion criteria, the access to this trial and drug is denied!” This has pushed me to take action.


The ACCELERATE platform offers a unique place to share, with no blame, no shame, all the issues perceived by the different participants in early drug development and we have found that solutions already exist as there is no real medical or legal hurdle. By working together, we can just do it… and we did!


We have reached a consensus where we all speak with a common voice to push inclusion of adolescents in early adult trials when medically justified (Gaspar et al. Annals of Oncology 2018). Since then the ACCELERATE FAIR trials group has moved forward to apply this in real life. The support of SIOPE and ITCC and their link with ESMO is of crucial importance. This is why it is so important for me to participate actively and chair the ACCELERATE FAIR trial group initiative along with a parent representative, Chris Copland of Unite2CURE and all the other stakeholders.
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