Psychodemographic characteristics of patients with rheumatic diseases in clinical trials: Preliminary findings
Abstract
Introduction: Clinical trials are an integral part of medical progress. Today, it would be difficult to imagine modern medicine without them. Clinical trials make it possible not only to assess the efficacy of new therapies but also their safety profile. Unfortunately, the increase in complexity of clinical trial protocols that have been observed in recent decades makes patient recruitment for clinical trials increasingly difficult. Patients not only have to meet strictly defined inclusion and exclusion criteria but also have to adapt their daily lives to the requirements of clinical trials.
Aim: This study aims to develop psychodemographic characteristics of patients with rheumatic diseases who had completed at least one clinical trial.
Material and methods: Sixty-nine (50K/19M) patients with rheumatic diseases were included in the study. The mean age of patients included in the study was 50.8 ± 12.9 years and the mean duration of disease was 13.1 ± 9.3 years.
The inclusion criterion for the study was the completion of at least one clinical trial. Patients enrolled in the study completed a questionnaire in which questions covered demographic data, subjective assessment of financial status and health status, and reasons for participating in the clinical trial.
Results: Patients participating in clinical trials include 66.5% of those with a secondary or higher education. Fifty-nine percent of patients rate their financial status as average and 61% of patients are economically active. Eighty-nine percent of patients rate their health status as poor or very poor before entering the clinical trial.
Conclusions: Patients participating in clinical trials are generally those with long disease duration, poor health status and a financial status that does not allow them to buy biologics.
Keywords: clinical trialsrheumatoid arthritispsoriatic arthritissystemic lupus erythematosusrheumatic diseases
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