Unite2Cure: calling for FAIR Trials

Our video sets out how young people with cancer are often excluded from research trials, without any just cause. This not only limits their individual options but holds back progress in finding better cures and kinder treatments for generations to come.

What are we doing about this and how can you help?

Unite2Cure has helped set up the  ACCELERATE working group on FAIR Trials in order to Foster Age Inclusive Research . Here we are working  with medical professionals, academic researchers, members of the pharmaceutical industry and those responsible for the ethics of research trials. The group is jointly led by a clinician, Nathalie Gaspar, and a parent, Chris Copland. You can find out more about the group here.

Our key proposal  is for  the age of entry to be reduced to 12 years in adult early phase studies (where medically justified). This may sound a bold target but there is no great obstacle in terms of law, regulation or safety. The issue, rather, is one of awareness and will within the research community. How then can we change this dogma?

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WHAT WE PLAN TO DO

  • Identify trials that are truly age inclusive and publicise these success stories as examples to follow
  • Lobby the pharmaceutical sector, with the help of our supporters within the industry, and put the issues to the wider research community
  • Engage with ethics committees at a local and national level, as well as with international networks like the European Forum for Good Clinical Practice
  • Provide a researchers’ toolkit so that the procedures and paperwork for making trials inclusive become easy options
  • State our case live, in the media and online

HOW YOU CAN HELP

  • If you work in Pharma or Research, complete our survey on current standards: ly/FAIR2018survey
  • 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

Do, therefore  contact me at chriscoplandatyork@gmail.com

We look forward to your active support,

Chris Copland, co-chair of the FAIR Trials working group

 

 

Accelerating Together

Last week, Unite2Cure participated actively in the ACCELERATE Paediatric Oncology Conference in Brussels. This event is a unique occasion for high-level experts to reflect upon and discuss concrete proposals to accelerate new oncology drug development for children and adolescents.

The conference is part of a unique multi-stakeholder joint initiative, the ACCELERATE multi-stakeholder Platform. Co-organised by CDDF, ITCC and SIOPE, this platform provides a transparent forum enabling patients and parents’ organisations, academic paediatric oncologists and haematologists, pharmaceutical companies and EU regulatory network representatives to collaborate and jointly address specific obstacles to faster and more effective treatments for children and adolescents with cancer, including the needed changes to the Paediatric Medicines Regulation.

Innovative therapies could target several paediatric malignancies and, thus, save many young lives. However today less than 1 in 10 children in relapse with a terminal cancer has access to these types of medicines, and investment in paediatric oncology drug development is insufficient.

Paediatric drug development is currently regulated in Europe via the EU Paediatric Regulation. 2017 is the year of the 10th year report by the European Commission on this Regulation: 10 years of learning, 10 years of success and failure, 10 years of interaction between stakeholders. A huge experience to build upon in order to accelerate innovation for children and adolescents with cancer.

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The Accelerate Conference provided us with a valuable opportunity to discuss successes and failures in paediatric development, as well as to discuss the strategies to accelerate new oncology drug development. It was also a chance to share experience, harmonize and strengthen the collaboration between all stakeholders at the international level (Parents, Academia, Regulators, Pharmaceutical Industry). This year was the 5th anniversary of the conference, and a wonderful chocolate cake was served to commemorate the event.

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Angela Polanco, one of Unite2Cure’s founding members, described her overall feeling about the conference: “It was an amazing few days spent with colleagues, friends and new friends. There exists so many possibilities for change and the people to make it happen includes you and me. Change can only be made with passion, dedication and consistency and by not being afraid to have a voice, even when the challenge seems so great. We are excited to see the progress made in the upcoming year, for all those children that deserve to live long and happy lives free from cancer.”

Some points that were presented and will remain a priority for Unite2Cure:

 The waivers for adult-only diseases are not relevant in oncology and must be amended: what is most important is the mechanism of action of a given drug,
 There must be prior discussions to select the most suited drugs in order to match the best available therapies with children suffering from rare or refractory malignancies,
 The delays must be reduced in starting paediatric development of potentially life-saving innovative drugs,
 The rewards must be more effective and flexible to increase the interest the development of new and specific paediatric medicines,
 We must get rid of the 18-year dogma and allow adolescents to participate in adults trials.

Delphine Heenen spoke to the audience about “Raising awareness and the EU political agenda” with a very well thought-out and moving presentation which drove home our message. She will be representing Unite2Cure again today at SIOPe’s ICCD in Brussels.

Here is just a small part of Delphine’s speech “When my son Raphaël was diagnosed with cancer in 2013, the comforting words most people felt obliged to say were really often the same: “I am so sorry but nowadays, treatments are making such progress, it’s going to be OK”. And I thought it was true. The irony is that IT IS NOT TRUE FOR CHILDREN. My son relapsed end 2015 and when I started inquiring more specifically into the best treatment options for his relapse, I was quite shocked to realise that the most recent drug he had received in 2013 dated back from 1988 -25 years! And the treatment for his relapse was not quite more innovative with the most recent drug being from 1998.
Children are treated with old drugs. They are left out of the innovation we read about almost every week in the papers for adult cancers.
I apologise for the comparison but the situation is shocking; hence shock is what I want to convey: cancer cures are not like movies. There should not be an “adult-only” section. Children and cure belong together!
And we can do better.”

 

 

Unite2Cure’s immediate goals following the conference are to continue to push for changes to the Paediatric Medicines Regulation in line with the Resolution adopted by the EU Parliament in December 2016. We will also begin working on the 18 age limit dogma – as there are no medical, legal or ethical reasons for adolescents not to be included in adult trials.

Together, we can make a difference!

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