Applied Clinical Trials
Teenagers with cancer could benefit from a proposed initiative to lower the age barrier for participation in trials for new oncology drugs.
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 (FAIR) 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 those under 18 cannot participate in many trials for new oncology drugs. “Teenagers with cancer must no longer be blocked from entering adult clinical trials,” the group 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, FAIR 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 manner. According to Chris Copland, parent representative and co-chair of FAIR, who underlines the “thousands of young lives we lose to cancer every year in Europe alone,” the current common exclusion of patients under 18 “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,” said Kearns. “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 in 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.”
SIOP 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”, the group notes.
As coronavirus spreads across northern Italy, the European Union is marshalling its forces to slow the spread of Covid-19. On Feb. 24, it announced an aid package worth $250 million (€232 million) to boost global prevention and containment. “As cases continue to rise, public health is the number one priority. Whether it be boosting preparedness in Europe, in China, or elsewhere, the international community must work together. Europe is here to play a leading role,” said Ursula von der Leyen, the president of the EU’s executive body, the European Commission.
Half the money will support the World Health Organization (WHO) in the bid to help countries with weaker health systems around the world. Her colleague Janez Lenarcic, who is responsible for crisis management, said: “With more than 2,600 lives lost already (as of Feb. 24), there is no option but to prepare at all levels. Our goal is to contain the outbreak at a global level.” The EU’s civil protection mechanism has been organizing the delivery of emergency medical supplies to China-including more than 30 tons of personal protective equipment donated by member countries. And $15 million has been allocated to the Institute Pasteur in Dakar, Senegal, to support rapid diagnosis measures and epidemiological surveillance.
But the EU is also focusing on its own member countries. According to Stella Kyriakides, the commissioner for health, “following the developments in Italy, the commission is stepping up its support to member states.”
Already in January, the commission promised $11 million in support of research into improving clinical care of patients infected with the virus, in addition to ongoing projects that have reoriented their activities to address the outbreak, addressing research preparedness of clinical treatment sites and the use of harmonized research protocols across Europe. The EU-funded European global virus archive project has also, as of late February, provided 79 countries with more than 1,000 diagnostic kits. Now $100 million will be put into a partnership with the pharmaceutical industry in a search for a vaccine, with another $10 million for research on epidemiology, diagnostics, therapeutics, and clinical management in containment and prevention.
Since the outbreak was reported in China, the EU has activated its own early warning and response system, and after an emergency meeting of health ministers from the member states, it coordinated work with ECDC and the European Medicines Agency (EMA) on risk assessments, case definition for diagnosis and reporting, and information on therapeutics and vaccines. It says there is “a strong overall level of preparedness with countries having response measures in place to provide treatment for the cases in the EU and to mitigate any further transmission within and into the EU.”
The U.K.’s BioIndustry Association commented last month that it was “inspiring to see how scientists around the world are working together to tackle the virus and the impressive speed in which the latest science is being shared globally.” But it also warned that some international agreements threaten to hinder such cooperation.
Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium