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.

Saturday, 5 July 2014

Will healthy ageing become a reality?

In the EU by 2025 more than 20% of Europeans will be 65 or over, with a particularly rapid increase in the number of over 80s. A major challenge for European governments is how to meet the higher demand for healthcare and ensure that healthcare systems meet the needs of the elderly.

The elderly have markedly different healthcare requirements to younger age groups but, at present, many services are not ideally tailored to suit their needs. For example, it has long been known that the elderly use a greater amount of medicines than younger patients. In a survey by the US National Center for HealthStatistics it was reported that 80% of the elderly population (adults aged 65 years and older) took at least one prescription drug in the prior month. The issue of polypharmacy is a particular concern in the elderly, who compared to younger individuals, tend to have more disease conditions for which medicines are required.

The European Commission’s (EC) official position is to actively support Member States in their efforts to promote healthy ageing through dedicated initiatives to improve the health of older people. There is a belief that an ageing population in good health will also mean less strain on health systems and fewer people retiring from work due to ill-health. At present, the European Innovation Partnership on Active and Healthy Ageing aims to ensure that the average European citizen has two more active and healthy years to live by 2020. The EC takes the view that ageing is an opportunity for Europe rather than a hindrance. However, Europe’s continuing economic crisis is creating uncertainty regarding the plans to improve healthcare for the elderly as governments are reluctant to invest in new areas. The experience in Greece serves as awarning of what can happen in the face of economic problems. As a result of the economic meltdown, doctors' wages in the public system have been cut in line with other government workers, and hospitals are at risk of being merged and face regular shortages of materials.

The ongoing economic difficulties in Europe may hinder investment in additional healthcare services for the elderly since politicians are looking to implement cutbacks. However, it must be remembered that the elderly also represent a growingproportion of the voting population and will therefore not accept their long-term healthcare needs being ignored.