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[Motivation and barriers to participation in clinical trials]
Charly Gaul1, Thomas Schmidt, Jürgen Helm
1Klinik und Poliklinik für Neurologie, Martin-Luther-Universität, Halle-Wittenberg, Germany. Charly.Gaul@gmx.de
Background:
Clinical trials are essential in clinically orientated medical research. Enrollment of patients is determined by patient-related barriers, protocol-related barriers, and motivation and behavior of the physician.
Main Theses:
Patients enrollment in clinical trials is determined by disease, possible diagnostic or therapeutic benefit of study procedures, effort of protocol procedures, and trust of the relationship between the physician and patient. Randomized trials, extensive study procedures and the possibility of receiving placebo are barriers to participation. Understanding of the communication process and knowledge of patients' needs are the base education to gain patients' informed consent to enter a clinical trial and a stable compliance in the course of the study. Motivation of physicians to enroll patients in a clinical trial is determined, e. g., by environmental conditions in clinic or doctors' office, the time and effort of study procedures, and individual academic interest.
Conclusion:
Awareness of factors (positive and negative) which influence motivation of participation in a clinical trial is useful to provide strategies for successful enrollment of patients.
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Cultural barriers:
Differences in values, beliefs, religion, knowledge, and tradition can significantly impact communication. Awareness of nonverbal cues is critical, especially when conversing with a patient from a different culture. What appears appropriate in one culture may be inappropriate in another.
Semantic barriers:
As a result of their tendency to use...
