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Applied Clinical Trials
Teenagers with cancer could benefit from a recommendation to lower the age barrier so they can take part in clinical trials says a proposal from the Fostering Age Inclusive Research Trials Initiative.
Teenagers with cancer could benefit from a recommendation to lower the age barrier so they can take part in clinical trials. The proposal came in mid-February from the Fostering Age Inclusive Research Trials Initiative, which embraces pediatric and medical oncologists, parents, civil society groups, researchers, and the drug industry.
The FAIR group maintains that teenagers with cancer are routinely prevented from trying out potentially lifesaving treatments because of a bureaucratic impediment that means under 18 cannot participate in many trials for new cancer drugs. “Teenagers with cancer must no longer be blocked from entering adult clinical trials,” it said in a statement, calling for a change of common practice. FAIR argues that the age of access should be cut from 18 to 12 years of age. This is the right and safe action to take, where medically justified, it claims.
The group has launched a teenage-friendly ‘Stamp of Approval’ encouraging all trials to be made accessible for young people with cancer in a safe and appropriate way. According to Chris Copland, parent representative and co-chair of the group, who underlines the “thousands of young lives we lose to cancer every year in Europe alone”, the current common exclusion of patients under eighteen “bears little relation to science, safety or compassion.” He sees the FAIR initiative as “a major step in the right direction.” For Dr. Nathalie Gaspar, a pediatric oncologist from the Gustave Roussy Cancer Campus in Paris, the “main fear is missing an opportunity to cure a young person, or at the very least being able to extend their young lives. It is utterly unbearable to tell a teenager, just because they are under 18, that they cannot participate in a trial, which may offer their last bit of hope.” In her view, the 18-year age barrier is “an artificial one and with no clinical evidence behind it.”
Professor Pamela Kearns of the Cancer Research UK Clinical Trials Unit, who is also the European president of the International Society for Pediatric Oncology (SIOP) says that despite improvements in the treatment of cancer and survival rates in some areas, “survival rates have in fact plateaued for certain childhood/teenage cancers”, particularly for metastasizing cancer and some brain tumors and sarcomas. “Much better, kinder drugs are becoming available downstream. We must make sure that our young people have the same access as adults if we are to see improvements in treatments and survival rates.”
SIOP argues that participation a trial should not be about whether a child is below or above 18 years of age, but about the way the drug works, the biology of the disease and the needs of the patient. “The future of clinical trials must change to meet the needs and the future of our young people,” it said. “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.”
It says that in Europe, more than 46,000 people aged 15 to 24 are diagnosed with cancer every year, and more than 6,000 die. “More than 100 children and young people die of cancer in Europe each week, and cancer is therefore the biggest killer by disease in this age group.”