Facilitators and barriers to the successful implementation of pediatric antibacterial drug trials: Findings from CTTI's survey of investigators
| Autor: | Chris Wheeler, Amy Corneli, Gary J. Noel, Jamie N. Roberts, Daniel K. Benjamin, John S. Bradley, Sumathi Nambiar, Li Lin, Breck Gamel |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
Pediatric Research Initiative Facilitators Clinical Trials and Supportive Activities Staffing Article 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Clinical Research Medicine 030212 general & internal medicine Pediatric antibacterial drug trials Antibacterial drug Pharmacology Pediatric lcsh:R5-920 business.industry General Medicine Pediatric clinical research 3. Good health Key factors Drug development Family medicine Parental consent lcsh:Medicine (General) business Inclusion (education) Barriers Blood drawing |
| Zdroj: | Contemporary Clinical Trials Communications Contemporary Clinical Trials Communications, Vol 9, Iss C, Pp 115-120 (2018) |
| Popis: | An urgent need exists to develop new antibacterial drugs for children. We conducted research with investigators of pediatric antibacterial drug trials to identify facilitators and barriers in the conduct of these trials. Seventy-three investigators completed an online survey assessing the importance of 15 facilitators (grouped in 5 topical categories) and the severity of 36 barriers (grouped in 6 topical categories) to implementing pediatric antibacterial drug trials. Analysis focused on the identification of key factors that facilitate the successful implementation of pediatric antibacterial drug trials and the key barriers to implementation. Almost all investigators identified two factors as very important facilitators: having site personnel for enrollment and having adequate funding. Other top factors were related to staffing. Among the barriers, factors related to parent concerns and consent were prominent, particularly obtaining parental consent when there was disagreement between parents, concerns about the number of blood draws, and concerns about the number of invasive procedures. Having overly narrow eligibility criteria was also identified as a major barrier. The survey findings suggest three areas in which to focus efforts to help facilitate ongoing drug development: (1) improving engagement with parents of children who may be eligible to enroll in a pediatric antibacterial drug trial, (2) broadening inclusion criteria to allow more participants to enroll, and (3) ensuring adequate staffing and establishing sustainable financial strategies, such as funding pediatric trial networks. The pediatric antibacterial drug trials enterprise is likely to benefit from focused efforts by all stakeholders to remove barriers and enhance facilitation. |
| Databáze: | OpenAIRE |
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