Joaquim Oristrell Salvà
Zdrowie Publiczne i Zarządzanie, Tom 9, Numer 1, 2011, s. 119 - 127
https://doi.org/10.4467/20842627OZ.11.009.0346The charter of older people rights to participate in clinical trials
The results of initial literature review indicate that elderly persons are underrepresented in the clinical trials on which clinical recommendations are based. This gave stimulus to perform the ‘Increasing the PaRticipation of the ElDerly In Clinical Trials’ (PREDICT) project, financed by the EU within the FP7. The goal of the PREDICT was to study reasons why older people are excluded from clinical trials based on age-related criteria and development of the charter including recommendations to prevent their exclusion. The project gathered investigators from 11 institutions in 9 countries: Czech Republic, Israel, Italy, Lithuania, the Netherlands, Poland, Romania, Spain, and the UK. Within the scope of PREDICT, first, to assess the scope of the problem the systematic review of literature was performed, then the opinion shared by the health care professionals, ethicists, and representatives of pharmaceutical industry on the possible reasons of underrepresentation of old people in trials was examined, then finally the opinion of elderly patients and their caregivers were assessed. The analysis of gathered data enabled creation of PREDICT charter which contains recommendations aiming to increase the participation of elderly people in clinical trials