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Barriers to conducting prospective multicentre studies in paediatric orthopaedics in Europe: Insights from the EPOS
Marco Turati1,2, Marco Crippa1,2,3, Nicolas Nicolaou4
1Orthopedic Department, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.
Insights
Initiating European multicentre paediatric orthopaedic studies faces significant bureaucratic and regulatory hurdles. Addressing these challenges requires streamlined processes and dedicated resources to improve research efficiency and collaboration.
Area of Science:
- Orthopaedic Surgery
- Paediatric Orthopaedics
- Clinical Research
Background:
- Prospective multicentre studies are vital for evidence-based advancements in medicine.
- Such rigorous investigations are notably scarce in European paediatric orthopaedics.
- This study examines barriers to initiating these crucial studies.
Purpose of the Study:
- To explore organizational, regulatory, and resource-related barriers hindering the initiation of prospective multicentre studies in paediatric orthopaedics.
- To analyze the setup phase of the EPOS Discoid Meniscus (DiMe) Project.
Main Methods:
- A cross-sectional survey was conducted among 19 centres recruited for the European Paediatric Orthopaedic Society DiMe Project cohort study.
- Assessed delays and obstacles during contract negotiation, ethics committee approval, and patient enrolment.
- Descriptive analysis characterized the initiation phase challenges.
Main Results:
- Median contract negotiation and ethical approval durations were 12 months and 3-12 months, respectively.
- 63.2% of centres were still in contract negotiation; 36.8% had progressed to patient enrolment.
- Bureaucratic delays, lack of institutional support, and administrative processes were major identified challenges.
Conclusions:
- Institutional and regulatory barriers significantly hinder the initiation of European multicentre studies in paediatric orthopaedics.
- Streamlining administrative and ethical processes is crucial.
- Improved resource and personnel allocation is needed to enhance efficiency and facilitate collaborations.
Purpose:
Prospective multicentre studies represent a cornerstone of evidence-based advancement. However, within orthopaedics, and particularly in the European context of paediatric orthopaedics, such rigorous investigations are notably scarce. This study aims to explore the organizational, regulatory, and resource-related barriers hindering initiation of these crucial studies, using the setup phase of the 'EPOS Discoid Meniscus (DiMe) Project: a Prospective Multicentric Cohort Protocol'.
Methods:
A cross-sectional survey was conducted from 19 centres initially recruited for the European Paediatric Orthopaedic Society DiMe Project (NCT05580315) cohort study. Delays and perceived obstacles encountered during initiation phases: contract negotiation, ethics committee approval, and patient enrolment were assessed. A descriptive analysis was performed to characterize the data. Twelve responding centres (63.2%) were still in the contract negotiation phase, while 36.8% (n = 7) had progressed to the patient enrolment stage.
Results:
Median duration for contract negotiation was 12 months (Q1-Q3: 7-22), matching ethical approval (Q1-Q3: 3-12). Sixty-three point two percent (n = 12) of responding centres were still in the contract negotiation phase, while 36.8% (n = 7) had progressed to patient enrolment, with 41 patients enrolled across these sites. Formal ethics committee submission was required de novo in 84.2% (n = 16) of responding centres. Major challenges identified included bureaucratic delays, lack of institutional support, absence of dedicated research staff, and prolonged administrative processes.
Conclusion:
The initiation of European multicentre studies in paediatric orthopaedics is hindered by institutional and regulatory barriers. Streamlining administrative and ethical processes and allocation of resources and personnel are needed to improve efficiency and facilitate successful collaborations.
Level Of Evidence:
V - Expert opinion / Cross-sectional survey.
