Exclusion from clinical trials for the elderly: protection or discrimination?

Last weekend I flew to Rome to attend the 1st European Expert Forum on Blood Cancer in the Elderly. The symposium, organized by ecancermedicalscience, brought together for the first time haematologists, oncologists and geriatricians from all Europe to discuss strategies to treat in the best possible ways haematological malignancies in elderly patients. While this kind of tumors, eg chronic myeloid leukemia, affects predominantly people over 65 years of age, elderly patients are not treated with the most innovative and targeted drugs as younger patients are.
Several are the misconceptions underlying the status quo for this category of patients, for which -as put with the words with one of the speakers, professor Lodovico Balducci from the Lee Moffett Cancer Centre, Florida- age represents a “risk factor for inadequate treatment” and, as a consequence, worse clinical outcome. For one, the anagraphical age of 65 yo is still used as a cut off to exclude patients from clinical trials. Such an exclusion is neither scientifically -as the biological, and not the anagraphical age is the relevant factor to take into account when deciding which therapy to administer- nor ethically justified, but represents an entrenched clinical routine.
A consensus emerged from the symposium that much needs to be done to eradicate it. Professor Antonio Cherubini (Institute of Gerontology and Geriatrics, Perugia University) and Dr Beatrice Lucaroni from the European Commission presented their data on PREDICT, a project of the 7th European Framework Programme focused on human development and ageing and aimed at increasing participation in clinical trials in the elderly. With the words of the European geriatricians that are members of the PREDICT consortium, they have all too frequently found themselves “in a situation where they are unable to prescribe the best course of treatment with the weight of scientific evidence behind them, due to insufficient evidence from clinical trials. […] In practice, clinicians are left to extrapolate from studies of younger, healthier subjects – a practice fraught with difficulty. An analogous problem has occurred in the paediatric context but research in this domain, is much better developed than for the frail older person“.
Two are the interwined issues to take into account when evaluating participation of the elderly in clinical trial: their ability to give informed consent and the risk of discrimination deriving from exclusion. The elderly patient is a very heterogeneous category, which needs propered tailored assessment and consequent stratigication to form the basis of personalized therapy. Indeed, the elderly patient can be fit and able to receive an aggressive treatment as the adult, or unfit for aggressive treatment and able to receive only a lower dose of treatment, or frail and therefore more vulnerable and in need of palliative care and of a complex and multidisciplinarity management by both the geriatricians and the (haemato) oncologist. On the one hand, the frail patient has often associated co-morbidities such as senile dementia, and is therefore unable to consent to informed consent models as the ones prepared for the unfrail patient. Therefore the frail elderly patient is in a vulnerable condition which deserves special protection. On the other hand, labelling elderly patients per se as vulnerable and excluding them from clinical trials represent a discrimination and an injustice, which can and indeed has negative consequences on prognosis and treatment. This was the message strongly put forward in the patient advocacy session by Giora Sharf, elderly CML survivor and head of the CML Advocates Network, and by Joerg Hasford, founding member of the German Drug Utilization Center. For the future, strategies to implement trial participation in the elderly, while taking care of their reduced autonomy and capacity to consent, need to be developed.

Further reading

Defining old: clinical challenges and changing ideas in haemato-oncology, Insider News, ecancermedicalscience, March 19, 2011.

Cherubini A, Del Signore S, Ouslander J, et al. Fighting against age discrimination in clinical trials. J Am Geriatr Soc. 2010 Sep;58(9):1791-6.

Kumar PS, Katheria K, et al. Evaluating the Older Patient with Cancer: Understanding Frailty and the Geriatric Assessment, CA Cancer J Clin 2010; 60:120-132.

Mallery LH, Moorhouse P. Respecting frailty. J Med Ethics 2011;37:126-128.

PREDICT project for Increasing the Participation of the ElDerly In Clinical Trials

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