1
views
0
recommends
+1 Recommend
1 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found

      Persistent exclusion of older people from clinical trials of cardiovascular and antithrombotic medicinal products

      ,
      European Geriatric Medicine
      Springer Science and Business Media LLC

      Read this article at

      ScienceOpenPublisher
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Related collections

          Most cited references3

          • Record: found
          • Abstract: not found
          • Article: not found

          Drug policy for an aging population--the European Medicines Agency's geriatric medicines strategy.

            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Exclusion of older people from clinical trials: professional views from nine European countries participating in the PREDICT study.

            There has been concern about under-representation of older people in clinical trials. The PREDICT study reported that older people and those with co-morbidity continue to be excluded unjustifiably from clinical trials. However, there is no information about differences of opinion on these issues between EU countries. The results of a survey of health-related professionals from nine EU countries that participated in the PREDICT study are presented in this study. The aim of the study was to identify and examine any differences of opinion between EU countries on the inclusion of older patients in clinical trials. A questionnaire using a Likert scale and free text was completed by 521 general practitioners, geriatricians, clinical researchers, ethicists, nurses and industry pharmacologists/pharmacists. The questions explored the impact of the present situation, possible reasons for under-representation and potential methods of improving participation. Countries participating were the Czech Republic, Israel, Italy, Lithuania, the Netherlands, Poland, Romania, Spain and the UK. There was agreement that exclusion from clinical trials on age grounds alone was unjustified (87%) and that under-representation of older people in trials caused difficulties for prescribers (79%) and patients (73%). There were national differences between professionals. All but the Lithuanians believed that older people were disadvantaged because of under-representation. The Czech, Lithuanian and Romanian professionals felt that it was justified to have age limits based on co-morbidity (61-83%) and polypharmacy (63-85%). Romanians also thought that having age limits on trial participation was justified because of reduced life expectancy (62%) and physical disability (58%) in older people. All but the Romanian professionals felt that the present arrangements for clinical trials were satisfactory (62%). All but the Israelis (56%) and Lithuanians (70%) agreed that regulation of clinical trials needed alteration. Although respondent selection bias cannot be excluded, the differences that emerged between countries may be the result of the political and healthcare-system differences between older and newer members of the EU. These differences may influence decision making about clinical trial regulations and practice in older people.
              Bookmark
              • Record: found
              • Abstract: not found
              • Article: not found

              Medicines for older people: assessment and transparency at the European medicines agency regarding cardiovascular and antithrombotic medicinal products

                Bookmark

                Author and article information

                Journal
                European Geriatric Medicine
                Eur Geriatr Med
                Springer Science and Business Media LLC
                1878-7657
                August 2018
                July 5 2018
                August 2018
                : 9
                : 4
                : 413-414
                Article
                10.1007/s41999-018-0080-0
                83f2a0f4-2638-4e68-af86-b8fe51d8524a
                © 2018

                http://www.springer.com/tdm

                History

                Comments

                Comment on this article