Brief Report: Implementation of a Universal Prescreening Protocol to Increase Recruitment to Lung Cancer Studies at a Veterans Affairs Cancer Center

Xiang, Jenny; Roy, Alicia; Summers, Christine; Delvy, Monica; O’Donovan, Jessica; Christensen, John C.; Dwy, Christopher; Perry, Lydia; Connery, Donna; Rose, Michal G.; Sheehan, Kelsey; Chao, Herta H.

doi:10.1016/j.jtocrr.2022.100357

Cited by 4 publications

(11 citation statements)

References 14 publications

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“…In terms of registry scope, 15 of the 24 included studies reported using national registries for trial pre-screening (Supplementary material 4 , papers 12/18/20/16/10/9/13/21/24/14/4/8/5/6/23) (respectively [ 42 , 43 , 45 , 46 , 48 – 51 , 54 , 57 – 59 , 62 , 63 , 65 ]), and 9 of 24 studies reported using local registries (Supplementary material 4 , papers 22/17/24/1/19/7/2/5/3) (respectively [ 44 , 53 – 56 , 60 – 62 , 64 ]). Local registries were either at a state level (Supplementary material 4 , papers 17 and 19) [ 53 , 56 ], or a specific site level (Supplementary material 4 , papers 22/1/7/2/3) (respectively [ 44 , 55 , 60 , 61 , 64 ]). Two included studies reported using a combination of local and national registries (Supplementary material 4 , papers 24 and 5) [ 54 , 62 ].…”

Section: Resultsmentioning

confidence: 99%

“…Only two international registries were reported being used for trial pre-screening (Supplementary material 4 , papers 15 and 11) [ 47 , 52 ]. We observed that 50% of the included studies reported pre-screening for drug trials (Supplementary material 4 , papers 22/16/15/10/21/1/14/8/7/2/6/23) (respectively [ 44 , 46 – 48 , 51 , 55 , 57 , 59 – 61 , 63 , 65 ]), and 50% of non-drug trials (Supplementary material 4 , papers 12/18/20/9//13/11/17/24/19/4/5/3) (respectively [ 42 , 43 , 45 , 49 , 50 , 52 – 54 , 56 , 58 , 62 , 64 ]). Only one registry and trial targeted a pediatric population (Supplementary material 4 , paper 14) [ 57 ].…”

Section: Resultsmentioning

confidence: 99%

“…In 11 of 24 studies, NCT numbers were not mentioned (Supplementary material 4 , papers 22/16/9/24/1/14/4/8/7/2/6) (respectively [ 44 , 46 , 49 , 54 , 55 , 57 – 61 , 63 ]) even though trial names were documented in ten of them (Supplementary material 4 , papers 22/16/9/1/14/4/8/7/2/6) (respectively [ 44 , 46 , 49 , 55 , 57 – 61 , 63 ]). Conflict of interests were disclosed in the vast majority of the studies with only one paper not disclosing them (Supplementary material 4 , paper 19) [ 56 ].…”

Section: Resultsmentioning

confidence: 99%

“…This is aligned with the ICTRP website that reports oncology and cardiovascular trials at the 1 st and 3 rd position for the numbers of trials by health category (the 2 nd place being for neuropsychiatric conditions) [ 39 ]. We found half of drug trials (compared to other interventions) in our included studies with 12 publications of the 24 included reporting registry usage for drug trial pre-screening [ 44 , 46 – 48 , 51 , 55 , 57 , 59 – 61 , 63 , 65 ]. This reflects the importance of drug trials in the clinical trial landscape, but should also be considered in relation to the disease domains they are associated with, as certain diseases call more for drug trials than non-drug trials.…”

Section: Discussionmentioning

confidence: 99%

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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: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

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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“…Pancreatic cancer trials require diversity and inclusion 22 and prescreening improves enrollment raes in clinic trials 23,24 Review each patient at initial MDR for portfolio of studies and trials…”

Section: Evaluation For Clinical Studies and Trialsmentioning

confidence: 99%

Development of a Neoadjuvant Treatment Pathway to Standardize Pancreatic Cancer Care and Improve Outcomes Across a Large Diverse Health System

Parakrama,

Sidiqi,

Demyan

et al. 2023

Preprint

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Background: Management of localized pancreatic cancer is variable. We describe the development of a neoadjuvant therapy pathway (NATP) to standardize care across a large healthcare system.   Methods: We conducted an IRB-approved retrospective analysis of NATP patients between June 2019 and March 2022. The primary endpoint was NATP completion, and secondary endpoints included overall survival (OS) and quality measures.   Results: Fifty-nine patients began NATP, median age 70, locally advanced 44.1%. Median time on NATP was 6.1 months. The initial chemotherapy was FOLFIRINOX (64.2%) and gemcitabine/nab-paclitaxel (GnP; (35.6%)) followed by radiation in 32 (54.2%) patients. Forty-four (74.6%) completed the NATP and 30 (50.8%) underwent surgical exploration with 86.7% undergoing successful resection (61.5% R0, 23.1% R1) while 14 remained unresectable. NATP completion was associated with increased likelihood of resection (p<0.001). At median follow-up of 13.4 months, median OS was 20.9 months (95% CI 13.3-28.5) and 1- and 2-year OS was 82.5% and 49.7%. NATP completion resulted in improved OS with median OS not reached and 1- and 2-year OS of 89.7% and 59.4% (p=0.004). Median time to NATP start was 20 days after MDR and median time to surgery was 35 days. Age, ECOG, surgical stage, chemotherapy regimen and NATP completion were significant univariable predictors of OS with ECOG status remaining significant on multivariable analysis. Conclusion: Our outcomes provide a baseline for future guidance in improving care across a large system. Efforts to complete NATP and improve patient ECOG may result in more patients undergoing surgery and improve survival.

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Initial Steps in Creating a Patient-Centric Addendum to Clinical Trial Informed Consent Forms

King-Kallimanis,

Ferris,

Dropkin

et al. 2023

JTO Clinical and Research Reports

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Brief Report: Implementation of a Universal Prescreening Protocol to Increase Recruitment to Lung Cancer Studies at a Veterans Affairs Cancer Center

Cited by 4 publications

References 14 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

Development of a Neoadjuvant Treatment Pathway to Standardize Pancreatic Cancer Care and Improve Outcomes Across a Large Diverse Health System

Initial Steps in Creating a Patient-Centric Addendum to Clinical Trial Informed Consent Forms

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