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AB1070 Could Enhanced Patient Education Improve The Outcome of Clinical Trials in Rheumatoid Arthritis?
  1. R.M. Cseuz1,
  2. M. Megyaszai1,
  3. B. Shenker1,
  4. A. Mirzahosseini2
  1. 1Revita Clinic
  2. 2Dept. of Pharmaceutical Chemistry, Semmelweis University, Budapest, Hungary

Abstract

Background Patient education is considered to be a highly cost-effective way to limit disability in rheumatic diseases as well as to achieve an improvement in quality of life. Since 1997 our team has carried out a variety of educational programs for RA patients [1]. Since the year 2000 several clinical trials have been carried out on RA patients at Revita Clinic.

Objectives Internationally, medical teams involved in clinical trials work according to the “gold standard” (ICH-GCP) based on regular training and international guidelines. It is suggested that apart from the known and obvious prerequisites for clinical trials, individual sites could add to the process of developing a new molecular entity by enhancing the education of recruited patients thereby improving compliance and reducing the failure rate of investigational products used in such trials.

Methods Data and statistical analyses from 16 RA studies on biologics & JAK inhibitors from the last 5 years involving 185 patients are presented of which 144 were involved in customized educational programs utilizing an educational DVD, and 6-week courses involving meetings with other patients, doctors, and physiotherapists. Compliance measured using standard and site-specific questionnaires were compared with meta-analyses of international studies. Efficacy measures a) withdrawal risk [2]; b) HAQ; c) DAS28; d) GAD VAS; e) Physician Assessment, were analyzed and compared with meta-analyses of international studies.

Results The mean withdrawal risk of Revita Clinic patients was found to be significantly lower compared to global data [2] (p<0.05). The mean DAS28 value change is -2.23±1.68, significantly higher than the global average of -1.17±0.67 [3] (p<0.0001). The mean HAQ value change is -0.39±0.54, significantly higher than the global average: -0.28±0.12 [3] (p<0.0001). The mean GAD VAS and Physician Assessment, changes are -26 and -30, respectively.

Conclusions The overall goal is to increase participation, reduce costs, and accelerate the time factor in clinical trials. The high failure rate of investigational products in such trials, especially in the later stages of development, is a significant contributor to the costs and time associated with bringing new molecular entities to market. Enhanced patient education might well help to overcome the present shortcomings thereby increasing the cost-effectiveness of clinical trials.

  1. Cseuz et al. EULAR Meeting 2003 [AB0634]

  2. Aaltonen et al. PloS ONE, 2012; 7: e30275.

  3. Bujkiewicz et al. Value Health, 2014; 17: 109–115.

Acknowledgement The painstaking work of the study nurse, A. Besenyei, and that of the study coordinator, K. Ivanics, are highly appreciated.

Disclosure of Interest None declared

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