3/2007Organization of clinical trials in primary care settings

INGA DŁUGOŃ (Medycyna Rodzinna S.A.Dyrektor medyczny: Piotr Olędzki)

Summary
The paper presents a model of clinical trial organization in primary care settings and benefits following participation in clinical trials. The experience of participation in clinical trials of our primary care centers has 7 years. So far clinical trials of II, III and IV phase have been performed. Following the development of our primary care centers the number of clinical trails in our facility was also growing. This development resulted in a necessity for changing of the model of organization of clinical trials and incorporation of new procedures. All clinical trials are performed according with rules of Good Clinical Practice (GCP) and Declaration of Helsinki. Well-run clinical trials use defined techniques and rigorous definitions to answer the researchers’ questions as accurately as possible. Each proposal of a clinical trial is assessed by a coordinating director of a medical staff. Choosing to participate in a clinical trial is an important decision based on a number of available experienced researchers, future possibilities of recruitment of patients and technical support of a chosen center. Any activities connected with participation in clinical trials are realized after regular time which should be dedicated to patients and they are extra-paid. Participation of general practitioners in clinical trials helps to include them to a research work.

Key words: clinical trials, primary care, general practitioner