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Inclusion of functional measures and frailty in the development and evaluation of medicines for older adults. | LitMetric

AI Article Synopsis

  • The ICH E7 guidelines for clinical trials involving individuals over 65 were introduced in 1994, but there has been minimal improvement in the inclusion of older adults, especially those over 75, in these studies.
  • Despite older adults being the primary consumers of medications, relevant health endpoints and safety data are often missing from clinical trial results and regulatory submissions.
  • The text outlines eight recommendations aimed at enhancing the involvement of frail older adults in clinical trials, emphasizing the need for collaboration among medical practitioners, regulators, pharmaceutical companies, and researchers to drive meaningful changes.

Article Abstract

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E7, the guidance for the conduct of clinical trials in people older than age 65 years, dates from 1994. Since then, the inclusion of older people in clinical trials has hardly improved, particularly for the oldest old age group (individuals older than age 75 years), which is the fastest growing demographic bracket in the EU. Even though most medications are taken by this group, relevant endpoints and safety outcomes for this cohort are rarely included and reported, both in clinical trials and regulatory approval documents. To improve the critical appraisal and the regulatory review of medicines taken by frail older adults, eight recommendations are presented and discussed in this Health Policy. These recommendations are brought together from different perspectives and experience of the treatment of older patients. On one side, the perspective of medical practitioners from various clinical disciplines, with their direct experience of clinical decision making; on the other, the perspective of regulators assessing the data submitted in medicine registration dossiers, their relevance to the risk-benefit balance for older patients, and the communication of the findings in the product information. Efforts to improve the participation of older people in clinical trials have been in place for more than a decade, with little success. The recommendations presented here are relevant for stakeholders, authorities, pharmaceutical companies, and researchers alike, as the implementation of these measures is not under the capacity of a single entity. Improving the inclusion of frail older adults requires awareness, focus, and action on the part of those who can effect a much needed change.

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Source
http://dx.doi.org/10.1016/S2666-7568(23)00208-8DOI Listing

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