Patients' perspectives and motivators to participate in clinical trials with novel therapies for rheumatoid arthritis.
OBJECTIVE
Successful advances in the treatment of rheumatoid arthritis rely on enrolment of patients into clinical trials with novel agents. The aim of this study was to assess the patients' perspectives and motivators to participate in clinical trials.


METHODS
Consecutive patients with rheumatoid arthritis attending three rheumatology departments in Romania underwent structured questionnaire interview regarding the motivation/possible causes of acceptance or drawbacks to participate in a clinical trial.


RESULTS
A total of 96 patients, mean age 48, 30% men 70% women answered. Response rate was 95%. Previous participation in other clinical trials was 23%. Patients were highly motivated to participate in order to help themselves or other patients and to enhance the knowledge about the disease. Patients were prone to ask for advice about their enrolment in the study from the family and their current physicians, including the general practitioner. The need for supplementary information about the study was felt because they had not dared to ask for the information, although they trusted their current doctor. A high percentage considered payment and free complete blood tests as a stimulus, especially among patients with lower levels of education (p = 0.03, Fisher's ANOVA). Advertising for investigational medical product for purposes of patient recruitment was important for 57%, not only for safety or trust, but also for transparency and as a tool to get information. 73% of the persons agreed to the usefulness of patients association. 26% of them were willing to be actively involved, especially to report and include adverse events in the study settings. 58% were motivated if they knew other patients were consulted. Patients were not motivated because of the adverse events, placebo effect, treatment discontinuation, limited previous experience, availability of alternative therapies and doctor reimbursement for the study.


CONCLUSIONS
The current study suggests that awareness of factors (positive and negative) which influence motivation to participate in a clinical trial may help to refine patient's education and to consider new strategies for future trials.
Udrea
G
G
"Carol Davila" University of Medicine, Bucharest, Romania. gabiudrea@yahoo.com
Dumitrescu
B
B
Purcarea
M
M
Balan
I
I
Rezus
E
E
Deculescu
D
D
D000328:Adult; D000368:Aged; D001172:Arthritis, Rheumatoid / Q000523:psychology* / Q000628:therapy; D001290:Attitude; D001364:Awareness; D002986:Clinical Trials as Topic; D004522:Educational Status; D004651:Employment; D005260:Female; D006801:Humans; D033181:Information Dissemination; D020407:Internet; D008297:Male; D008875:Middle Aged; D009042:Motivation; D010358:Patient Participation / Q000523:psychology*; D018579:Patient Selection; D010361:Patients / Q000523:psychology*; D012383:Romania; D011795:Surveys and Questionnaires; D055815:Young Adult