Experts have warned that teenage cancer patients are missing out on the chance to take part in clinical trials, which Steven Bradshaw believes could have an impact on the wider industry going forward.
Steven Bradshaw: Pharmaceuticals Expert
Dr Steven Bradshaw is a medical expert to the pharmaceuticals and research industry. In this role, Bradshaw acts in an advisory capacity to some of the world’s most notable pharmaceuticals chains. Bradshaw’s industry experience often sees him comment on current issues, such as the recent decision by the Italian government to substitute AMD drugs, providing the industry at large with fresh insight to develop their understanding of the wider market.
Bradshaw’s experience within the pharmaceuticals industry has taught him that clinical trials are essential to the development of emerging treatments and for their eventual approval and reimbursement.
Young Patients Are Falling Through the Gap
Which is why the recent warning given out by industry experts over the lack of teenage cancer patients in clinical trials, because they do not fit into either the paediatric or adult categories, is of particular concern.
Specifically, Co-ordinator of the National Cancer Research Institute’s Teenage and Young Adult Clinical Studies Group, Dr Lorna Fern, has noted that patients often do better when they are afforded the chance to take part in clinical trials, because of the specialist care they receive. However, Fern went on to warn that because of their age, “too many of our young patients are needlessly falling through the gap.” And yet research led by Fern, and funded by the Teenage Cancer Trust and NCRI, illustrates that this issue is easy to rectify; all the industry needs to do is set more flexible age limits on clinical trials.
We Need Wider Age Limits
Published in Lancet Oncology, the research found that clinical trials that included wider age limits, coupled with better awareness and availability, allowed more teenagers and adults to take part. Specifically, according to the study, between 2005 and 2010, it recorded a 13% rise in 15-19 year olds taking part in clinical trials.
Fern commented on the results, saying that: “By encouraging doctors to take into account the full age range of patients affected by individual types of cancer, we’ve shown that it’s possible to design trials that include teenage cancer patients and, importantly, that better match the underlying biology of the disease and the people affected.”
Researchers Will Be Required to Justify Age Restrictions
Furthermore, Cancer Research UK pledged, as a result of these findings, to ask researchers to justify any age restrictions they choose to place on new studies, in order to lift the numbers of teenagers taking part.
Cancer Research UK’s Director of clinical trials, Kate Law, further said that: “We now only accept age limits on our clinical trials if they are backed up by hard evidence, which will hopefully mean more young cancer patients get the chance to contribute to research and have the latest experimental treatments.”
Also, the charity’s director of services, Simon Fuller, added that “changes are critical to improving the quality of life and chances of survival for young people with cancer aged 13 to 24.” Fuller then went on to call on everyone involved in the commissioning and regulating of clinical trials “to work together across the UK, Europe and internationally to help save young people’s lives.”
Steven Bradshaw Believes in Broader Age Limits for Clinical Trials
In Steven Bradshaw’s opinion, the experts have a valid point, which the wider industry needs to take note of. Broadening the age limits for clinical trials will allow a wider cross section of the public to be allowed in those trials, which will provide researchers with a greater depth of information concerning the new treatments they are testing. However, it is a well-known fact that for an effective treatment, a label with a restrictive population, which might be based on age, often stands a better chance of being eventually reimbursed than one with broader limits in its inclusion criteria. Clinical trials need to have pre-defined inclusion criteria: the decision for these is often for practical reasons (does this condition affect patients of this age?), for statistical reasons (will we be able to recruit enough patients?), for reasons to identify those subpopulations of patients who would potentially benefit the most, and for reasons of cost – to contain the costs of the clinical development program and to contain the costs of the customer.
For cancer, there is huge unmet need to help patients get access to innovative therapies and being involved in clinical trials is often the only way for patients to try something that might help an otherwise terminal condition. The main question is what limits are going to be acceptable and beneficial to researchers, patients, clinicians and decision makers, and how will this be funded? Further debate is definitely needed.