Andrea Wamuth1, Andrea Schuckelt1, Dominique Jacobs1, Sarah Kuisl1, Andreea Lavrov1, Jutta Goldberg1
1) Germany
Clinical trials in children with long-term pain are challenging. A previous trial enrolling 199 children with malignant and non-malignant pain for a 15-day opioid treatment, reported a recruitment rate of 0.1 patients/site/month. We were targeting a minimum of 60 sites to recruit 129 patients.
Global feasibility was performed for a clinical trial enrolling children aged 6 to less than 18 years old, being in need of at least 14 days treatment with a strong oral opioid. After initial contact via phone or mail, a feasibility questionnaire was sent to interested sites followed by a site visit prior to final selection. Commitment to enroll at least 2 patients per year was requested. There was no restriction regarding site specialization or previous trial experience. The following feasibility data were analyzed: Selected countries, number of sites contacted, number of sites indicating interest, number of finally selected sites and reasons for not being interested in the trial.
Overall 1465 sites were contacted in 44 countries across 5 continents. Only 484 sites returned the feasibility questionnaire, of these 215 sites expressed their interest to participate in the trial. After further evaluation of the regulatory and legal landscape (e.g. approval timelines, drug handling) some countries had to be excluded. Of the remaining 34 countries, 18 countries were dropped due to limited number of sites available following a feasibility visit. In the remaining 16 countries 53 sites could be selected. The 269 sites that reported no interest gave as main reasons “lack of patients being in need of 14 days treatment with a strong opioid” (58%) and “lack of resources” (6%).
Performing clinical trials in long-term moderate to severe pain in children is challenging as low recruitment rates per site cannot easily be compensated by increasing the number of sites.
