• MaasAndrew I RAIRhttp://orcid.org/0000-0003-1612-1264Department of Neurosurgery, Antwerp University Hospital and University of Antwerp, Drie Eikenstraat 655, 2650, Edegem, Belgium. andrew.maas@uza.be., Ari Ercole, Veronique De Keyser, David K Menon, and Ewout W Steyerberg.
• Department of Neurosurgery, Antwerp University Hospital and University of Antwerp, Drie Eikenstraat 655, 2650, Edegem, Belgium. andrew.maas@uza.be.
• Neurocrit Care. 2022 Aug 1; 37 (Suppl 2): 192-201.

AbstractStrong evidence in support of guidelines for traumatic brain injury (TBI) is lacking. Large-scale observational studies may offer a complementary source of evidence to clinical trials to improve the care and outcome for patients with TBI. They are, however, challenging to execute. In this review, we aim to characterize opportunities and challenges of large-scale collaborative research in neurotrauma. We use the setup and conduct of Collaborative European Neurotrauma Effectiveness Research in TBI (CENTER-TBI) as an illustrative example. We highlight the importance of building a team and of developing a network for younger researchers, thus investing toward the future. We involved investigators early in the design phase and recognized their efforts in a group contributor list on all publications. We found, however, that translation to academic credits often failed, and we suggest that the current system of academic credits be critically appraised. We found substantial variability in consent procedures for participant enrollment within and between countries. Overall, obtaining approvals typically required 4-6 months, with outliers up to 18 months. Research costs varied considerably across Europe and should be defined by center. We substantially underestimated costs of data curation, and we suggest that 15-20% of the budget be reserved for this purpose. Streamlining analyses and accommodating external research proposals demanded a structured approach. We implemented a systematic inventory of study plans and found this effective in maintaining oversight and in promoting collaboration between research groups. Ensuring good use of the data was a prominent feature in the review of external proposals. Multiple interactions occurred with industrial partners, mainly related to biomarkers and neuroimaging, and resulted in various formal collaborations, substantially extending the scope of CENTER-TBI. Overall, CENTER-TBI has been productive, with over 250 international peer-reviewed publications. We have ensured mechanisms to maintain the infrastructure and continued analyses. We see potential for individual patient data meta-analyses in connection to other large-scale projects. Our collaboration with Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) has taught us that although standardized data collection and coding according to common data elements can facilitate such meta-analyses, further data harmonization is required for meaningful results. Both CENTER-TBI and TRACK-TBI have demonstrated the complexity of the conduct of large-scale collaborative studies that produce high-quality science and new insights.© 2022. Springer Science+Business Media, LLC, part of Springer Nature and Neurocritical Care Society.

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