Multi-stakeholder supports to FAIR Trial Initiative

Multi-stakeholder support

Paediatric and Medical Oncologists

Fostering Age Inclusive Research (FAIR) Trials for Adolescents & Young Adult

Paediatric and medical oncologists in Europe are transforming the ACCELERATE FAIR Trials initiative into a country by country action plan. They are working together to break the 18 years dogma, despite the fact that countries have different health care structures, early drug development programmes and approaches to AYA population care.

List of AYA Clinical Sites

Patient and Parent advocates

Fostering Age Inclusive Research (FAIR) Trials for Adolescents & Young Adults

Patient and parent advocates play a fundamental role for the success of the FAIR trials initiative. Please find below some useful links:




Mariana Coutinho, Portugal

“Personally, I have witnessed how devastating it can be for a teenager to receive the news that they can’t be helped because they don’t meet an age inclusion criteria. A friend of mine, who was diagnosed with rhabdomyosarcoma and was just a few months away from being 18 years old, was denied access to a clinical trial because of his age. I am thrilled to be part of this initiative as a patient advocate and I wish to help shape the dialogue and raise awareness on this very important issue, hoping to encourage the different stakeholders to recognise how not only patients but also the medical and research community can benefit from this more inclusive approach.”

Patient and Parent Advoactes

From left to right: Chris Copland (Unite2cure), Max Williamson (Teenage and Young Adult representative, National Cancer Research Institute), Debbie Binner (Create for Chloe), Lynley Marshall (Royal Marsden)

Industry

Fostering Age Inclusive Research (FAIR) Trials for Adolescents & Young Adults

From an industry perspective, the inclusion of adolescent and young adults is an important initiative that allows this patient population access to experimental therapies in a more timely manner than traditional paediatric trials. It is well recognised that adolescent and young adults are often underrepresented in clinical trials and hopefully this is one important step in overcoming this issue.


The inclusion of this patient population can also be important in helping guide paediatric patients most likely to respond to new experimental agents by obtaining early evidence of activity in these children, improving the design and focus of subsequent trials in paediatrics.

Expanding inclusion of these patients into adult trials may also help reduce the economic burden of developing novel treatments by identifying drugs that are not likely to be effective in children, or with toxicity profiles that may be contraindicated in children at a much earlier stage than has been traditionally achieved.


As we expand our knowledge of the important molecular differences between most adult and paediatric tumours, these changes with inclusion of adolescent and young adults into adult trials and comparison of the resultant biology may also provide critical improvement in our underlying understanding of paediatric tumours.



Regulatory

Fostering Age Inclusive Research (FAIR) Trials for Adolescents & Young Adults

Spring 2019 has brought statements of support for age inclusive research from three major international health forums.

‘The European Medicines Agency (EMA) and its Paediatric Committee (PDCO) follow closely and with great interest the Accelerate’s FAIR (Foster Age-Inclusive Research) initiative… We sincerely appreciate your efforts and hope we can all continue to work together to improve the development of medicines for children with cancer.’


Read the full letter from the EMA (April 2019)

‘The US Food and Drugs Administration recommends the inclusion of adolescent patients in disease- and target-appropriate adult oncology clinical trials to enable earlier access to investigational and approved drugs for adolescent patients with cancer.’


FDA (March 2019)

Endorsements

Fostering Age Inclusive Research (FAIR) Trials for Adolescents & Young Adults

‘As part of the responsibility to provide better medicines for children, the European Forum for Good Clinical Practice strongly recommends:

That researchers, regulators, and members of ethics committees weigh the totality of physiologic, pathologic, and other disease specific evidence to consider adolescent inclusion in adult research and vice versa – young adults as an extension population in paediatric/adolescent studies – when relevant as a trial methodology to facilitate earlier access to investigational and approved medicines for adolescent patients.’


EFGCP Children’s Medicines Working Party (March 2019)

Advancing Medicines Development for Adolescents: The EFGCP Children’s Medicines Working Party Adolescent Initiative by Christina Bucci-Rechtweg on behalf of the EFGCP CMWP Adolescent Initiative.


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