Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Better Medicines for Older People - The EMA Geriatric Medicines Strategy

Dr. Martina Arnold (Abschlußjahr: 2013)

Summary
Language: English

Europe, like other parts of the world, is facing a demographic change due to its ageing population. According to the current demographic projection, the population aged 65 or above will grow from estimated 87 million in 2010 to 153 million in 2060, with the share of the elderly increasing from 17.4% to 29.5%.
As the demographic development has been known for a long time, the regulatory agencies started to foster the inclusion of geriatric patents in clinical trials in the late 1980s. As a consequence, in 1993, the International Conference on Harmonisation released guidance on clinical studies in geriatric patients (ICH E7). Since then, the prevalence of elderly and very elderly people continued to increase and several additional issues have been identified that require further consideration.
In 2011, the EMA published its Geriatric Medicines Strategy comprising two central aspects: The development of safe and efficacious medicines for the geriatric population and the improvement of the available information on the use of medicines in the elderly. As announced in the strategy paper, the EMA has sought to interact with stakeholders and invited to a workshop for discussion on the strategy and the planned measures in March 2012.
Although, according to ICH E7, elderly patients with concomitant diseases and the very old should not be unnecessarily excluded, these patients are usually underrepresented in clinical trials. The inclusion of very old and comorbid patients in the clinical development programme requires adaptations in the study design, like extension of the eligibility criteria and age-appropriate endpoints, which in turn increases the heterogeneity of the study population and highly impacts the statistical planning and analysis.
Other challenges that require special consideration at inclusion of elderly patients in clinical trials are recruitment and retention. Apart from the study design, which should be as simple as possible and avoid unnecessary burden for the patient, the physician plays a major role.
For already authorised medicinal products, the new pharmacovigilance legislation, by strengthening of spontaneous reporting, provides the opportunity to collect additional data on elderly patients.
A current study, analysing the EPARs and SmPCs of non-generic products approved by the EMA in the years 2008 to 2010, showed that although 79% of the examined EPARs provided information on the ICH E7 items, but only 56% of the respective SmPCs. As laid down in the strategy paper, the EMA updated the assessment report template with regard to geriatric data in November 2011. The analysis of products approved by the EMA in 2012, which was carried out as part of this master thesis, showed that the update of the assessment report template as well as the inclusion of elderly, renally and hepatically impaired patients as special populations in the SmPC (although not implemented in the QRD templates) have contributed to improve the availability of information on the use of medicines in geriatric patients.

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