All professionals involved in the long process of medicines development are familiar with the fact that most clinical trials are performed in adult populations. Some 20 years ago both the EMA and the FDA, accepting the suggestions of many pediatricians and their scientific associations, made compulsory, for all new drugs, the execution of clinical trials also in the pediatric population.

We are now left with another big issue: the collection of scientific evidence from clinical trials (and from RWE data) of the use of drugs in elderly and very elderly people. Indeed, approximately two years ago, the EMA published some recommendations (non-compulsory) and addressed the issue of the development of drugs for elderly people: now, after two years, an international group of professionals in Medical Affairs wrote a commentary, in order to keep alive this important discussion, for the benefit of public health.

 “In 2020, the EMA published a reflection paper,‘Pharmaceutical development of medicines for use in the older population’ which discussed how the emerging needs of an aging European population can be addressed by medicines regulation. The paper intended to help industry to better consider the needs of older people during pharmaceutical/clinical medicines development by summarising data on the most relevant topics, providing early suggestions on how to move forward and prompting expert discussions and studies into knowledge gaps. Topics included patient acceptability, (dis)advantages of an administration route, formulation, dosage form, packaging, dosing device and user instruction. While the paper was directed at older people and the pharmaceutical industry, the reflections were also relevant to younger patients with similar disease-related needs and of value to other stakeholders’ parties (healthcare professionals, academics, patients and caregivers) as the paper made clear what can be expected from industry and where collaborative work is needed.

This commentary offers an overview of the different steps in the development of the reflection paper, discusses points considered most controversial and/or subject to (multidisciplinary) expert discussions and indicates their value for real-world clinical practice.”

Read the full article here.

References

  1. Riet‐Nales, D. A., Bemt, B., Bodegom, D., Cerreta, F., Dooley, B., Eggenschwyler, D., Hirschlérova, B., Jansen, P. A. F., Karapinar‐Çarkit, F., Moran, A., Span, J., Stegemann, S., & Sundberg, K. (2022, February 9). Commentary on the EMA reflection paper on the pharmaceutical development of medicines for use in the older population. British Journal of Clinical Pharmacology, 88(4), 1500–1514. https://doi.org/10.1111/bcp.15207

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  • The material in these reviews is from various public open access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
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