Wednesday, 23 July 2014

Tackling the under representation of the elderly in clinical trials

The pharmaceutical industry will need to adapt its R&D efforts to the requirements of the growing elderly population. In the US it has been predicted that by 2030, the elderly will represent 20% of the population and in Europe they may represent a quarter of the population. The World Health Organization believes that companies need to focus more on developing patient-centred rather than disease-related measures in order to satisfy the ‘real’ needs of a global ageing population.

One of the challenges companies must overcome is that the elderly are under-represented in clinical trials. This means that the scientific evidence base for many medicines used for the elderly is rather small, which makes it difficult for physicians to have confidence in what they prescribe. A number of European geriatricians have gone as far as to launch a charter against ageism in clinical trials, highlighting that practical issues in involving elderly in clinical trials are not the only reason for such observations. Their views are the result of their involvement in the European-wide PREDICT (Increasing the PaRticipation of the ElDerly In Clinical Trials) consortium. The consortium members are based in the Czech Republic, Israel, Italy, Lithuania, the Netherlands, Poland, Romania, Spain and the United Kingdom and co-ordinated from Medical Economics & Research Centre Sheffield, UK.

The aim of PREDICT is to investigate reasons for the exclusion of the elderly in clinical trials and to provide solutions for this problem. The group published some of its conclusions in a peer-reviewed paper in the Archives of Internal Medicine, which focused primarily on the extent of exclusion of older individuals in ongoing clinical trials regarding heart failure.

The European Medicines Agency (EMA) has also taken account of the demographic implications of ageing. It has engaged with other regulators, pharmaceutical companies and organisations representing the interests of elderly people in Europe in order to improve the current situation. In March 2012 it held a two-day workshop to discuss the EMA’s geriatric medicines strategy and related activities, so that gaps in the strategy could be identified. The EMA hopes that a presentation of its strategy in this field will provide opportunity for the identification of synergy areas between stakeholders. The Agency has also participated in other initiatives focused on geriatric medicine. In July 2013, UCL hosted a public engagement workshop, which featured members of the geriatric community, family carers, professionals from academic research, industry and regulatory agencies.

Although the elderly are currently under represented in clinical trials, the ongoing discussions between stakeholders suggest a more optimistic future. Those behind PREDICT highlight that an analogous problem occurred in thepaediatric population but research in this domain has considerably improved and therefore offers an example of what can be achieved through dedicated efforts focusing on special populations.

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