The impact of the COVID-19 pandemic on early termination of ophthalmology clinical trials: A cross-sectional analysis of ClinicalTrials.gov
Objective: To study the effect of the COVID-19 pandemic on the early termination of ophthalmology clinical trials. Methods: On June 10, 2022, we searched ClinicalTrials.gov and identified clinical trials pertaining to eye diseases. We included trials last updated between January 1, 2020 and June 8,...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2023-12-01
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| Series: | SAGE Open Medicine |
| Online Access: | https://doi.org/10.1177/20503121231216592 |
| _version_ | 1797399441357930496 |
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| author | Akash Kakkilaya Karan Hooda Praneeth Kalva Harshith Dasara Christopher Janssen Satvik Vasireddy Arbab Ahmed Salman Khan Karanjit Kooner |
| author_facet | Akash Kakkilaya Karan Hooda Praneeth Kalva Harshith Dasara Christopher Janssen Satvik Vasireddy Arbab Ahmed Salman Khan Karanjit Kooner |
| author_sort | Akash Kakkilaya |
| collection | DOAJ |
| description | Objective: To study the effect of the COVID-19 pandemic on the early termination of ophthalmology clinical trials. Methods: On June 10, 2022, we searched ClinicalTrials.gov and identified clinical trials pertaining to eye diseases. We included trials last updated between January 1, 2020 and June 8, 2022, as ones possibly impacted by the pandemic. We selected all interventional trials in any stage and country that were “recruiting,” “active, not recruiting,” “enrolling by invitation,” “suspended,” “terminated,” “completed,” or “withdrawn” and excluded trials that had been completed or discontinued before 2020, had incomplete data, trials in which the eye was not the primary focus of the trial (e.g., Chediak-Higashi syndrome, myasthenia gravis). The following trial-level characteristics were collected: location, trial status, enrollment count, ocular condition, sponsors, intervention purpose, trial phase (I–IV), randomization, number of arms, and reasons for discontinuation. In addition to calculating descriptive statistics, we assessed whether trial characteristics differed between ophthalmology clinical trials canceled due to COVID-19 and those canceled for other reasons. Results: Following the screening, 2280/12,679 (18%) ophthalmology clinical trials were retained. Of these, 142 (6.2%) were discontinued between January 1, 2020 and June 8, 2022. Moreover, 34 out of 142 (23.9%) ophthalmology clinical trials were discontinued due to COVID-19. These trials were more likely to be sponsored by academic medical centers (26/34, 76.5% vs 57/108, 52.8%, p = 0.03) and were not assigned to a specific study phase, indicating they were not investigational new drugs (22/34, 64.7% vs 46/108 42.6%, p = 0.003). Conclusions: COVID-19-related trial discontinuations were more likely to be reported by academic medical centers and associated with trials investigating fully approved drugs, medical devices, procedures, diagnostic imaging, and behavioral changes. Further investigation of these characteristics may lead to a more robust and resilient understanding of the causes of early termination of these clinical trials. |
| first_indexed | 2024-03-09T01:39:19Z |
| format | Article |
| id | doaj.art-a50d5c1b58254f3a864ec2271559a0dd |
| institution | Directory Open Access Journal |
| issn | 2050-3121 |
| language | English |
| last_indexed | 2024-03-09T01:39:19Z |
| publishDate | 2023-12-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | SAGE Open Medicine |
| spelling | doaj.art-a50d5c1b58254f3a864ec2271559a0dd2023-12-08T17:03:19ZengSAGE PublishingSAGE Open Medicine2050-31212023-12-011110.1177/20503121231216592The impact of the COVID-19 pandemic on early termination of ophthalmology clinical trials: A cross-sectional analysis of ClinicalTrials.govAkash Kakkilaya0Karan Hooda1Praneeth Kalva2Harshith Dasara3Christopher Janssen4Satvik Vasireddy5Arbab Ahmed6Salman Khan7Karanjit Kooner8Texas A&M University School of Medicine, Bryan, TX, USATexas A&M University School of Medicine, Bryan, TX, USADepartment of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, USATexas A&M University School of Medicine, Bryan, TX, USATexas A&M University School of Medicine, Bryan, TX, USATouro University Nevada College of Osteopathic Medicine, Henderson, NV, USATexas A&M University School of Medicine, Bryan, TX, USATexas A&M University School of Medicine, Bryan, TX, USADepartment of Ophthalmology, Veteran Affairs North Texas Health Care Medical Center, Dallas, TX, USAObjective: To study the effect of the COVID-19 pandemic on the early termination of ophthalmology clinical trials. Methods: On June 10, 2022, we searched ClinicalTrials.gov and identified clinical trials pertaining to eye diseases. We included trials last updated between January 1, 2020 and June 8, 2022, as ones possibly impacted by the pandemic. We selected all interventional trials in any stage and country that were “recruiting,” “active, not recruiting,” “enrolling by invitation,” “suspended,” “terminated,” “completed,” or “withdrawn” and excluded trials that had been completed or discontinued before 2020, had incomplete data, trials in which the eye was not the primary focus of the trial (e.g., Chediak-Higashi syndrome, myasthenia gravis). The following trial-level characteristics were collected: location, trial status, enrollment count, ocular condition, sponsors, intervention purpose, trial phase (I–IV), randomization, number of arms, and reasons for discontinuation. In addition to calculating descriptive statistics, we assessed whether trial characteristics differed between ophthalmology clinical trials canceled due to COVID-19 and those canceled for other reasons. Results: Following the screening, 2280/12,679 (18%) ophthalmology clinical trials were retained. Of these, 142 (6.2%) were discontinued between January 1, 2020 and June 8, 2022. Moreover, 34 out of 142 (23.9%) ophthalmology clinical trials were discontinued due to COVID-19. These trials were more likely to be sponsored by academic medical centers (26/34, 76.5% vs 57/108, 52.8%, p = 0.03) and were not assigned to a specific study phase, indicating they were not investigational new drugs (22/34, 64.7% vs 46/108 42.6%, p = 0.003). Conclusions: COVID-19-related trial discontinuations were more likely to be reported by academic medical centers and associated with trials investigating fully approved drugs, medical devices, procedures, diagnostic imaging, and behavioral changes. Further investigation of these characteristics may lead to a more robust and resilient understanding of the causes of early termination of these clinical trials.https://doi.org/10.1177/20503121231216592 |
| spellingShingle | Akash Kakkilaya Karan Hooda Praneeth Kalva Harshith Dasara Christopher Janssen Satvik Vasireddy Arbab Ahmed Salman Khan Karanjit Kooner The impact of the COVID-19 pandemic on early termination of ophthalmology clinical trials: A cross-sectional analysis of ClinicalTrials.gov SAGE Open Medicine |
| title | The impact of the COVID-19 pandemic on early termination of ophthalmology clinical trials: A cross-sectional analysis of ClinicalTrials.gov |
| title_full | The impact of the COVID-19 pandemic on early termination of ophthalmology clinical trials: A cross-sectional analysis of ClinicalTrials.gov |
| title_fullStr | The impact of the COVID-19 pandemic on early termination of ophthalmology clinical trials: A cross-sectional analysis of ClinicalTrials.gov |
| title_full_unstemmed | The impact of the COVID-19 pandemic on early termination of ophthalmology clinical trials: A cross-sectional analysis of ClinicalTrials.gov |
| title_short | The impact of the COVID-19 pandemic on early termination of ophthalmology clinical trials: A cross-sectional analysis of ClinicalTrials.gov |
| title_sort | impact of the covid 19 pandemic on early termination of ophthalmology clinical trials a cross sectional analysis of clinicaltrials gov |
| url | https://doi.org/10.1177/20503121231216592 |
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