Table 3.
Advantages and learnings of NH services from BPCRN and Pedmed-NL.
Topic | Advantages | Learnings | Future perspectives | Stakeholders to overcome pitfalls |
---|---|---|---|---|
Streamlined processes | High quality and speed of service | Multiple checkpoints in verifying delivered data on recruitment and site capabilities ensure the precision and quality in trial estimates based on current and historical knowledge. | Showcasing the improvement/advantages due to NH facilitation (through metrics), which resulted in potential cost reduction and lower trial failure rate for the sponsor. | NH, sponsors |
Continuous communication and information between Central SPoC, NH and site. | More flexible/ad hoc capacity within NH needed. Adaptable to the learning curve of collaboration with sponsors. | Standardization of communication process within a NH and multidisciplinary teams. Early inclusion of a NH to connect with the potential sites. | NH, trial sites | |
Improved feasibility-related data quality | More transparent and reliable data due to standardized process, e.g., CFS. | The NH creates time-efficient and quality completion on site level (Figure 1). | Centralization of all trial requests, from site level as well as from the sponsor level. | NH, sponsor, trial sites |
Potential for having trial-specific peer-to-peer explanation of the trial. | Enhancing knowledge per protocol at NH provides valuable in-depth understanding, and the inclusion of and enchancing the inclusion of sites. | Investment into protocol knowledge was relevant when being consulted for multiple phases of the trial or multiple trials within the same indication. | NH, trial sites | |
National-specific knowledge | Peer-to-peer personal connection and removal of language barrier. | Importance of maintaining knowledge of personnel on a national-level sustained growth and continuity. | Continuity of the NH team as well as local maintenance of site connection and site engagement. | NH |
Site-specific improvement | Support of inexperienced sites | The time-intensive process of naïve site development requires dedicated trial budget | Building a community and interaction between different sites exchanging, including previously naive sites. | NH, trial sites |
Trial-specific advice in terms of trial implementation or recruitment optimization | NHs can advise and link sites to expertise of recruitment optimizations as well as review the sponsors recruitment plan for national adjustments. | Experience of NH broader selection of trials and recruitment analysis, reaching a standardized recruitment process with patient engagement. | NH, trial sites, sponsor | |
A continuous and nationally adapted support system that can support the sites with for example budget support. | A NH ad hoc approach to site improvement navigation is time-intensive but ensures quality start-up and actual capability of a site. | Allowing a bottom-up approach with regard to engagement to the network and its activities/services. Budget support for both investigator-initiated and industry trials to allow reliable and sufficient budgets. | NH, trial sites | |
Access to a larger patient pool | By bringing multiple types of institutions together, a larger patient pool can be reached. | Diverse trials, such as those for rare diseases or medical devices, provide unique opportunities to access varied patient pools, needing different type of (quality) sites. | Early involvement of the network in the trial roll-out and network preparation. Progression of more naive sites and/or decentralized infrastructure for long-term follow-up. | Sponsor, NH |
Peer-to-peer structure | Access to existing network and trust, improving speed and quality of communication. | Rebuilding connections every 2 years offers the opportunity to refresh relationships and stay updated with evolving needs and trends within the field and the respective network. | Including at least one senior pediatrician within the national hub and involving younger members in the network maintenance. | NN |