Vol 9, No 3 (2023)
Review paper
Published online: 2023-06-14

open access

Page views 229
Article views/downloads 193
Get Citation

Connect on Social Media

Connect on Social Media

Psychodemographic characteristics of patients with rheumatic diseases in clinical trials: Preliminary findings

Marta Jeka1, Daniel Jeka2, Eugeniusz Daniszewski3, Ewa Mojs4
Rheumatology Forum 2023;9(3):140-144.

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.

Article available in PDF format

View PDF Download PDF file

References

  1. Waxman HA. The lessons of Vioxx--drug safety and sales. N Engl J Med. 2005; 352(25): 2576–2578.
  2. Kim JH, Scialli AR. Thalidomide: the tragedy of birth defects and the effective treatment of disease. Toxicol Sci. 2011; 122(1): 1–6.
  3. Hoffman J. New York City foster home accused of unethical AIDS drug trials. Nat Med. 2005; 11(1): 5.
  4. Ahmad K. Ethics of AIDS drug trials on foster children questioned. Lancet Infect Dis. 2005; 5(6): 333–334.
  5. Goldman DA. Thalidomide use: past history and current implications for practice. Oncol Nurs Forum. 2001; 28(3): 471–477.
  6. Krumholz HM, Ross JS, Presler AH, et al. What have we learnt from Vioxx? BMJ. 2007; 334(7585): 120–123.
  7. Garner S, Fidan D, Frankish R, et al. Rofecoxib for the treatment of rheumatoid arthritis. Cochrane Database Syst Rev. 2002(2): CD003685.
  8. Anderson A, Borfitz D, Getz K. Global Public Attitudes About Clinical Research and Patient Experiences With Clinical Trials. JAMA Netw Open. 2018; 1(6): e182969.
  9. Obarska I. Nierówność w dostępie do leczenia biologicznego w chorobach autoimmunizacyjnych w Europie. Refundacja apteczna szansą na poprawę efektywności leczenia w Polsce. Polski Związek Pracodawców Przemysłu Farmaceutycznego, Warszawa 2022.
  10. Terslev L, Ostergaard M. Rheumatoid Arthritis Relapse and Remission - Advancing Our Predictive Capability Using Modern Imaging. J Inflamm Res. 2021; 14: 2547–2555.