Introduction: There is evidence that cancer patients treated in clinical trials have significantly better outcomes than patients who are not enrolled in study protocols. In ovarian cancer, engagement in clinical trials is an indicator for the quality of care. However, information about the causes for withholding subjects from entering a clinical trial is sparse.
Methods: From May to November 2003, a questionnaire comprising 5 different dimensions was sent to all gynecological departments in Germany with at least 45 hospital beds. Eligible institutions had not participated in ovarian cancer trials run by either of the two German ovarian cancer study groups, that is, the Arbeitsgemeinschaft Gynakologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR) or the Nord-Ostdeutsche Gesellschaft fur Gynakologische Onkologie (NOGGO), since 1999. The questionnaire could be returned anonymously.
Results: The overall response rate was 42.6% (118 of 277 institutions). Altogether, 85 clinics signaled they are not participating in clinical trials for patients with ovarian cancer. The most commonly noted arguments of non-participants in a statistically weighted ranking list were limited resources for documentation (84.7%), or for informing patients (82.4%), and high costs of study treatment (65.9%). About 47.1% of non-participants stated patients declined informed consent, and that taking part in a trial is an additional burden. Administrative services refused permission to take part in the survey in 4.7% of all cases.
Conclusions: Inadequate infrastructures are the most relevant barriers for gynecological departments in Germany to participate in clinical trials. The reported data underline the need for intensifying continued education, and to strengthen awareness of the importance of clinical trials in gynecologic oncology.