Abstract
Background: Clinical trials for the treatment of pediatric orthopaedics are critical to enhance the quality of life of these children. In response to the COVID-19 pandemic, the FDA updated guidance on conducting clinical trials to prioritize patient safety; however the degree to which the pandemic disrupted pediatric orthopaedic-related clinical trials is unknown. Thus, our objective is to quantify the number of these trials disrupted due to the COVID-19 pandemic.
Methods: We searched ClinicalTrials.gov for ongoing and discontinued trials between 01/01/2020 - 10/31/2021. Trials were screened for relevance to the study and the number of participants, trial location, funding source, and reason for discontinuation. Associations between reasons for termination, funding source, trial location, and the number of participants enrolled were evaluated using MannWhitney U tests or ANOVA, where appropriate.
Results: Our search returned 544 trials, of which 128 were included with a total of 15,194 participants. Of the included Pediatric trials of orthopedic conditions, 9 were discontinued with a total of 497 participants. Of the 9 discontinued trials, 1 of 3 stated COVID-19 as a reason. Mann-Whitney U tests and ANOVA showed no statistically significant difference in enrollment between trials discontinued due to COVID-19 compared to other discontinued trials, nor among funding or location.
Conclusion: Our study shows 33% of discontinued pediatric orthopaedic-related clinical trials cited COVID-19 as a reason for discontinuation; however, only 12% of all children enrolled in discontinued trials. Findings from this study highlight the importance of developing strategies for safely continuing clinical research amid global emergencies that will almost certainly arise in the future.
Methods: We searched ClinicalTrials.gov for ongoing and discontinued trials between 01/01/2020 - 10/31/2021. Trials were screened for relevance to the study and the number of participants, trial location, funding source, and reason for discontinuation. Associations between reasons for termination, funding source, trial location, and the number of participants enrolled were evaluated using MannWhitney U tests or ANOVA, where appropriate.
Results: Our search returned 544 trials, of which 128 were included with a total of 15,194 participants. Of the included Pediatric trials of orthopedic conditions, 9 were discontinued with a total of 497 participants. Of the 9 discontinued trials, 1 of 3 stated COVID-19 as a reason. Mann-Whitney U tests and ANOVA showed no statistically significant difference in enrollment between trials discontinued due to COVID-19 compared to other discontinued trials, nor among funding or location.
Conclusion: Our study shows 33% of discontinued pediatric orthopaedic-related clinical trials cited COVID-19 as a reason for discontinuation; however, only 12% of all children enrolled in discontinued trials. Findings from this study highlight the importance of developing strategies for safely continuing clinical research amid global emergencies that will almost certainly arise in the future.
| Original language | American English |
|---|---|
| Pages | 118 |
| State | Published - 18 Feb 2022 |
| Event | Oklahoma State University Center for Health Sciences Research Week 2022 : Poster Presentation - Oklahoma State University Center for Health Sciences, Tulsa, United States Duration: 14 Feb 2022 → 18 Feb 2022 |
Conference
| Conference | Oklahoma State University Center for Health Sciences Research Week 2022 |
|---|---|
| Country/Territory | United States |
| City | Tulsa |
| Period | 14/02/22 → 18/02/22 |
Keywords
- Pediatric
- Orthopaedics
- Clinical Trials
- COVID-19