Research on the Current Status of New Drug Development in and Information Provision for Elderly Patients

Abstract

In the present study, we investigated differences in the proportion of geriatric patients between in clinical practice and in clinical trials. We also investigated information about drug treatment in elderly patients which were provided in package inserts to consider better drug development strategy and provision of information for geriatric patients. Diseases commonly found in the elderly were selected based on the Japanese guideline for medical treatment and its safety in the elderly 2015, and all the new drugs (new active substances and drugs with new indications) approved between April 2010 and March 2016 in Japan with the indication for the selected diseases were picked out. For each of these drugs, number of total subjects and geriatric subjects which were enrolled in clinical trials were collected based on disclosed documents. We also investigated age distribution of patients of the selected diseases in clinical practice based on a public report of patient survey 2014. Proportion of geriatric patients in clinical trials was smaller than that in clinical practices. Furthermore, degree of the gap was small in patients aged between 65 and 74, and it was large in the elderly aged 75 or over. Almost all the information about drug treatments in geriatric patients provided in package inserts was for calling caution with stereotypical comments in accordance with the notification from Ministry of Health, Labour and Welfare. There were few drugs of which measures for safety concerns were provided in its package insert. It is important to collect and evaluate clinical efficacy and safety of new drugs in geriatric patients during the development phase, and at the same time, to appropriately and continuously provide the latest information to medical personnel through monitoring their use in geriatric patients in clinical practice and providing knowledge that there is little difference in medication between elderly and non-elderly patients.