Onkológia 6/2023

Clinical research – changes in processes Are there expected changes in research within patients 65 plus?

Clinical research of new drugs over the past decades has seen the significant changes in the organization and content as well. The decreasing trend in new clinical trials has been seen in Europe, therefore Europe reacted by adopting new processes. A new legislative standard through Regulation no. 536/2014 (Regulation) was accepted in order to unify and shorten the start-up and regulatory processes during the course of clinical trials. The continuous aging of the population in Europe brings the need to ensure access to new drugs for elderly population. Regulation in order to improve the availability of drugs encourages research of new agents with expected significant clinical efficacy in vulnerable patients including the elderly. There is also a requirement of the high expertness in evaluation of clinical studies. Due to the changes in population, it is needed to perform clinical research in line with Regulation supported by commercial and non-commercial sponsors as in the elderly population to obtain data on the safety and efficacy of new drugs.

Keywords: clinical trial, patient 65+, innovative drugs, barriers to participation in clinical trials