How many sites should an orthopedic trauma prospective multicenter trial have? A marginal analysis of the Major Extremity Trauma Research Consortium completed trials
Abstract Background Multicenter trials in orthopedic trauma are costly, yet crucial to advance the science behind clinical care. The number of sites is a key cost determinant. Each site has a fixed overhead cost, so more sites cost more to the study. However, more sites can reduce total costs by sho...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2024-02-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-024-07917-0 |
| _version_ | 1797273349391384576 |
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| author | Lauren Allen Robert V. O’Toole Michael J. Bosse William T. Obremskey Kristin R. Archer Lisa K. Cannada Jaimie Shores Lisa M. Reider Katherine P. Frey Anthony R. Carlini Elena D. Staguhn Renan C. Castillo |
| author_facet | Lauren Allen Robert V. O’Toole Michael J. Bosse William T. Obremskey Kristin R. Archer Lisa K. Cannada Jaimie Shores Lisa M. Reider Katherine P. Frey Anthony R. Carlini Elena D. Staguhn Renan C. Castillo |
| author_sort | Lauren Allen |
| collection | DOAJ |
| description | Abstract Background Multicenter trials in orthopedic trauma are costly, yet crucial to advance the science behind clinical care. The number of sites is a key cost determinant. Each site has a fixed overhead cost, so more sites cost more to the study. However, more sites can reduce total costs by shortening the study duration. We propose to determine the optimal number of sites based on known costs and predictable site enrollment. Methods This retrospective marginal analysis utilized administrative and financial data from 12 trials completed by the Major Extremity Trauma Research Consortium. The studies varied in size, design, and clinical focus. Enrollment across the studies ranged from 1054 to 33 patients. Design ranged from an observational study with light data collection to a placebo-controlled, double-blinded, randomized controlled trial. Initial modeling identified the optimal number of sites for each study and sensitivity analyses determined the sensitivity of the model to variation in fixed overhead costs. Results No study was optimized in terms of the number of participating sites. Excess sites ranged from 2 to 39. Excess costs associated with extra sites ranged from $17K to $330K with a median excess cost of $96K. Excess costs were, on average, 7% of the total study budget. Sensitivity analyses demonstrated that studies with higher overhead costs require more sites to complete the study as quickly as possible. Conclusions Our data support that this model may be used by clinical researchers to achieve future study goals in a more cost-effective manner. Trial registration Please see Table 1 for individual trial registration numbers and dates of registration. |
| first_indexed | 2024-03-07T14:43:05Z |
| format | Article |
| id | doaj.art-cb2713b31a1548959c28ef82e89e033a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-07T14:43:05Z |
| publishDate | 2024-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-cb2713b31a1548959c28ef82e89e033a2024-03-05T20:11:06ZengBMCTrials1745-62152024-02-0125111110.1186/s13063-024-07917-0How many sites should an orthopedic trauma prospective multicenter trial have? A marginal analysis of the Major Extremity Trauma Research Consortium completed trialsLauren Allen0Robert V. O’Toole1Michael J. Bosse2William T. Obremskey3Kristin R. Archer4Lisa K. Cannada5Jaimie Shores6Lisa M. Reider7Katherine P. Frey8Anthony R. Carlini9Elena D. Staguhn10Renan C. Castillo11Department of Health Policy and Management, Johns Hopkins University Bloomberg School of Public HealthDepartment of Orthopaedics, University of Maryland School of MedicineAtrium Health Carolinas Medical CenterDepartment of Orthopaedic Surgery, Vanderbilt University Medical CenterDepartment of Orthopaedic Surgery, Vanderbilt University Medical CenterNovant Health Orthopedic Fracture ClinicSchool of Medicine, Johns Hopkins UniversityDepartment of Health Policy and Management, Johns Hopkins University Bloomberg School of Public HealthDepartment of Health Policy and Management, Johns Hopkins University Bloomberg School of Public HealthDepartment of Health Policy and Management, Johns Hopkins University Bloomberg School of Public HealthDepartment of Health Policy and Management, Johns Hopkins University Bloomberg School of Public HealthDepartment of Health Policy and Management, Johns Hopkins University Bloomberg School of Public HealthAbstract Background Multicenter trials in orthopedic trauma are costly, yet crucial to advance the science behind clinical care. The number of sites is a key cost determinant. Each site has a fixed overhead cost, so more sites cost more to the study. However, more sites can reduce total costs by shortening the study duration. We propose to determine the optimal number of sites based on known costs and predictable site enrollment. Methods This retrospective marginal analysis utilized administrative and financial data from 12 trials completed by the Major Extremity Trauma Research Consortium. The studies varied in size, design, and clinical focus. Enrollment across the studies ranged from 1054 to 33 patients. Design ranged from an observational study with light data collection to a placebo-controlled, double-blinded, randomized controlled trial. Initial modeling identified the optimal number of sites for each study and sensitivity analyses determined the sensitivity of the model to variation in fixed overhead costs. Results No study was optimized in terms of the number of participating sites. Excess sites ranged from 2 to 39. Excess costs associated with extra sites ranged from $17K to $330K with a median excess cost of $96K. Excess costs were, on average, 7% of the total study budget. Sensitivity analyses demonstrated that studies with higher overhead costs require more sites to complete the study as quickly as possible. Conclusions Our data support that this model may be used by clinical researchers to achieve future study goals in a more cost-effective manner. Trial registration Please see Table 1 for individual trial registration numbers and dates of registration.https://doi.org/10.1186/s13063-024-07917-0Multicenter trialsResearch operationsFinancial management |
| spellingShingle | Lauren Allen Robert V. O’Toole Michael J. Bosse William T. Obremskey Kristin R. Archer Lisa K. Cannada Jaimie Shores Lisa M. Reider Katherine P. Frey Anthony R. Carlini Elena D. Staguhn Renan C. Castillo How many sites should an orthopedic trauma prospective multicenter trial have? A marginal analysis of the Major Extremity Trauma Research Consortium completed trials Trials Multicenter trials Research operations Financial management |
| title | How many sites should an orthopedic trauma prospective multicenter trial have? A marginal analysis of the Major Extremity Trauma Research Consortium completed trials |
| title_full | How many sites should an orthopedic trauma prospective multicenter trial have? A marginal analysis of the Major Extremity Trauma Research Consortium completed trials |
| title_fullStr | How many sites should an orthopedic trauma prospective multicenter trial have? A marginal analysis of the Major Extremity Trauma Research Consortium completed trials |
| title_full_unstemmed | How many sites should an orthopedic trauma prospective multicenter trial have? A marginal analysis of the Major Extremity Trauma Research Consortium completed trials |
| title_short | How many sites should an orthopedic trauma prospective multicenter trial have? A marginal analysis of the Major Extremity Trauma Research Consortium completed trials |
| title_sort | how many sites should an orthopedic trauma prospective multicenter trial have a marginal analysis of the major extremity trauma research consortium completed trials |
| topic | Multicenter trials Research operations Financial management |
| url | https://doi.org/10.1186/s13063-024-07917-0 |
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