Recording and reporting of recruitment strategies in trial protocols, registries, and publications was nonexistent

Greene, Evelyn O’Sullivan; Shiely, Frances

doi:10.1016/j.jclinepi.2022.10.014

Cited by 6 publications

(2 citation statements)

References 57 publications

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“…One might argue that these benefits are not reflecting the current reality: since January 2014 there was a mean of 50,000 clinical trials running each year [ 39 ] and only 24 studies between 2014 and 2022 reported using population registries for pre-screening despite advantages with this method. However, the literature is known to under-report recruitment strategies in clinical trials, from protocols to publications [ 98 , 99 ]. This leads to restrictive data, as this systematic review only reflects research that reported registry use in a clinical trial pre-screening setting.…”

Section: Discussionmentioning

confidence: 99%

The usage of population and disease registries as pre-screening tools for clinical trials, a systematic review

Foucher,

Azizi,

Öijerstedt

et al. 2024

Syst Rev

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Objective This systematic review aims to outline the use of population and disease registries for clinical trial pre-screening. Materials and methods The search was conducted in the time period of January 2014 to December 2022 in three databases: MEDLINE, Embase, and Web of Science Core Collection. References were screened using the Rayyan software, firstly based on titles and abstracts only, and secondly through full text review. Quality of the included studies was assessed using the List of Included Studies and quality Assurance in Review tool, enabling inclusion of publications of only moderate to high quality. Results The search originally identified 1430 citations, but only 24 studies were included, reporting the use of population and/or disease registries for trial pre-screening. Nine disease domains were represented, with 54% of studies using registries based in the USA, and 62.5% of the studies using national registries. Half of the studies reported usage for drug trials, and over 478,679 patients were identified through registries in this review. Main advantages of the pre-screening methodology were reduced financial burden and time reduction. Discussion and conclusion The use of registries for trial pre-screening increases reproducibility of the pre-screening process across trials and sites, allowing for implementation and improvement of a quality assurance process. Pre-screening strategies seem under-reported, and we encourage more trials to use and describe their pre-screening processes, as there is a need for standardized methodological guidelines.

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Section: Discussionmentioning

confidence: 99%

The usage of population and disease registries as pre-screening tools for clinical trials, a systematic review

Foucher,

Azizi,

Öijerstedt

et al. 2024

Syst Rev

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“…Additionally, the patient recruitment strategies utilized by each clinical trial should be reported, at least as supplementary material, so that their efficacy can be evaluated for future trials. Although researchers routinely formulate recruitment strategies in order to attain internal review board approval of their trials, O'Sullivan Greene and Shiely showed that virtually no clinical trials reported this information in either registries or publications, leading to poor dissemination of improved recruitment strategies across institutions 25 .…”

Section: Overall Orthopaedic Trial Discontinuationmentioning

confidence: 99%

What Factors Are Associated with Clinical Trial Discontinuation in Orthopaedic Surgery

Hecht,

Guyler,

Shah

et al. 2023

Journal of Bone and Joint Surgery

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Background: Clinical trials play a crucial role in advancing medical knowledge and have the potential to change standards of care. The present study evaluated the prevalence of discontinued clinical trials in orthopaedic surgery. Additionally, we sought to identify the study characteristics associated with and the rationale behind trial discontinuation. Methods: A cross-sectional survey of orthopaedic clinical trials using the ClinicalTrials.gov registry and results database was performed for trials between October 1, 2007, and October 7, 2022. Interventional trials listed as "completed," "terminated," "withdrawn," or "suspended" were included. Study characteristics were collected and clinical trial abstracts were reviewed in order to assign the appropriate subspecialty category. A univariate linear regression analysis was performed to determine whether the percentage of discontinued trials changed between 2008 and 2021. Univariate and multivariable hazard ratios (HRs) were calculated to identify factors associated with trial discontinuation. Results: A total of 8,603 clinical trials were included in the final analysis, of which 1,369 (16%) were discontinued, with the highest rates of discontinuation found in oncology (25%) and trauma (23%). The most common rationales for discontinuation were insufficient patient accrual (29%), technical or logistical issues (9%), business decision (9%), and lack of funding or resources (9%). Industry-funded studies were more likely than government-funded studies to be discontinued (HR: 1.81; p < 0.001). There was no change in the percentage of discontinued trials for each orthopaedic subspecialty between 2008 and 2021 (p = 0.21). As shown on multivariable regression analysis, trials for devices (HR: 1.63 [95% confidence interval, 1.20 to 2.21]; p = 0.002) and drugs (HR: 1.48 [1.10 to 2.02]; p = 0.013) as well as Phase-2 trials (HR: 1.35 [1.09 to 1.69]; p = 0.010), Phase-3 trials (HR: 1.39 [1.09 to 1.78]; p = 0.010), and Phase-4 trials (HR: 1.44 [1.14 to 1.81]; p = 0.010) had a higher likelihood of early discontinuation. However, pediatric trials were less likely to be discontinued (HR: 0.58 [0.40 to 0.86]; p = 0.007). Conclusions:The results of the present study suggest the need for continued efforts to ensure the completion of orthopaedic clinical trials in order to limit publication bias and to employ resources and patient contributions more efficiently for research. continued Disclosure: The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJS/H549).

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Gender Bias in Clinical Trial Enrollment: Female Authorship Matters

Chhaya

Binion

Mulles

et al. 2023

Annals of Vascular Surgery

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Recording and reporting of recruitment strategies in trial protocols, registries, and publications was nonexistent

Cited by 6 publications

References 57 publications

The usage of population and disease registries as pre-screening tools for clinical trials, a systematic review

The usage of population and disease registries as pre-screening tools for clinical trials, a systematic review

What Factors Are Associated with Clinical Trial Discontinuation in Orthopaedic Surgery

Gender Bias in Clinical Trial Enrollment: Female Authorship Matters

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