The surgical oncology clinical trial landscape: A cross-sectional analysis of ClinicalTrials.gov from 2008-2020.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1561-1561
Author(s):  
Nirosha D. Perera ◽  
Brandon E. Turner ◽  
Jolie Z. Shen ◽  
Bonnie O. Wong ◽  
Henry K. Litt ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cox Regression ◽  
Surgical Oncology ◽  
Treatment Modalities ◽  
Early Discontinuation ◽  
Cross Sectional ◽  
Surgical Interventions ◽  
Funding Sources ◽  
Oncology Clinical Trials ◽  
Results Reporting

1561 Background: Surgical interventions are studied less often than medical or radiation interventions in oncology clinical trials. We characterized surgical oncology trials registered on ClinicalTrials.gov, analyzed funding sources and identified features associated with early discontinuation and results reporting. Methods: We employed a cross-sectional study design with descriptive, logistic regression, cox regression, time series and survival analyses. We downloaded all 270,172 studies registered on the Aggregate Analysis of the ClinicalTrials.gov database from October 1, 2008 to March 9, 2020. After excluding non-interventional trials, applying cancer/oncology specific Medical Subject Heading terms to the remaining trials and excluding phase 1 trials, 27,915 trials were identified for manual review. Primary exposure variables were trial focus: neoplasia site and treatment modality (surgical interventions included investigations of outcomes from surgical resection or intra-operative/peri-operative changes), and funding: industry, U.S. government, academic. Results: 26,815 trials were found to have true oncology content; 1,661 (6.2%) involved surgical oncology, representing 311,789 patients. Funding sources were: 82.7% by academic institutions, 10.9% by industry, and 6.2% by U.S. government. The most studied neoplasia sites were colorectal (17.4% of trials), breast (10.7%), gastric (10.5%), hepatic (8.6%), lung (7.5%), brain/CNS (6.7%) and cervical (6.6%). U.S. government funded surgical oncology trials had the lowest risk of early discontinuation (adjusted HR 0.65, 95% CI: 0.58-0.73, p<0.001) and the highest odds of results reporting (adjusted OR 1.35, 95% CI: 1.08-1.68, p=0.008) (Table). Conclusions: There is a paucity of surgical oncology clinical trials compared to other treatment modalities, especially in context of surgery’s role in overall cancer care. From 2008-2020 only 6.2% of trials focused on surgical oncology, and U.S. government funded trials displayed the lowest hazard of early discontinuation and highest odds of results reporting. Stakeholders should look to government funded trials as models of improvement, but must increase representation and results dissemination of surgical oncology trials to guide treatment recommendations. Surgical oncology trial features and associated early discontinuation/results reporting.[Table: see text]

The gastrointestinal clinical trial landscape: A cross-sectional analysis of clinicaltrials.gov from 2007-2019.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 468-468
Author(s):  
Nirosha Perera ◽  
Marija Kamceva ◽  
Jolie Z. Shen ◽  
Siyou Song ◽  
Jessica Steinberg ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Study Design ◽  
Disease Process ◽  
Phase Iii ◽  
Academic Institutions ◽  
Early Discontinuation ◽  
Cross Sectional ◽  
Methodological Rigor ◽  
Results Reporting ◽  
The U.S

468 Background: The burden of gastrointestinal (GI) disease is high, costing over $97 billion annually in the United States (U.S.) alone. Yet the methodological rigor and characteristics of trials leading to guideline development are rarely explored. In 2007, the U.S. mandated that all interventional studies (Phase II-IV) register with ClinicalTrials.gov, the largest international clinical trial database. We characterized registered GI trials to identify features associated with early discontinuation, results reporting and increased methodological rigor. Methods: We employed a cross-sectional study design with descriptive, logistic regression, cox regression, time series and survival analyses. We downloaded data for 327 075 studies registered on the Aggregate Analysis of the ClinicalTrials.gov database from October 1, 2007 to December 31, 2019. Trials were excluded if registered prior to 2007 (n=38 111) or for non-interventional study design (n=69 233). After applying GI specific Medical Subject Heading terms to the remaining 219 731 trials, 22 339 trials were identified for manual review. 20 548 trials were found to contain true GI content, representing over seven million patients. Primary exposure variables were trial focus (disease process, anatomical location) and funding (industry, U.S. government, academic). Results: Of the 20 548 GI trials, 6.1% were funded by the U.S. government, 35.6% by industry, and 58.3% by academic institutions. The most studied disease process was neoplasia (42.6% of trials), followed by viral hepatitis (10.8%). The majority of neoplasia trials were funded by academic institutions (60.3%) and studied colorectal neoplasms (31.5%), followed by hepatic (17.9%), pancreatic (15.5%), gastric (12.8%), esophageal (10.6%) and biliary tract (4.9%) neoplasms. U.S. government funded trials had the lowest risk of early discontinuation (adjusted Hazard Ratio 0.63, 95% CI: 0.48-0.83, p<0.001) and the highest rates of results reporting (25%, X2 p<0.001). Among all trials, the majority did not report Data Monitoring Committee (DMC) oversight (58.6%). Only 12% of phase III trials employed a rigorous methodology, which we defined as being randomized, double blinded, multi-site, overseen by a DMC, and having enrolled ≥50 patients. Government sponsored trials had the highest proportion of trials meeting this definition (19%). Academic sponsored trials, constituting the majority of trials overall, had the lowest proportion (5.3%), in part due to not meeting the multi-site criteria. Conclusions: Despite constituting the minority of trials overall, U.S. government funded trials displayed the highest methodological rigor. Stakeholders can look to U.S. government funded trials as a model of improvement, but nevertheless must commit to increasing methodological rigor and results dissemination to strengthen trial findings that guide GI clinical recommendations.

scholarly journals Associations of Plant-Based Foods and Diets with Gestational Diabetes: A Systematic Review of Observational Studies and Clinical Trials

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 948-948
Author(s):  
Tristesse Burton ◽  
James Alexander ◽  
Petar Planinic ◽  
Arpita Basu
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Gestational Diabetes ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Chinese Herb ◽  
Nutrition Therapy ◽  
Cross Sectional ◽  
Evening Primrose ◽  
Funding Sources

Abstract Objectives Gestational diabetes mellitus (GDM) is one of the most common health complications during pregnancy. Medical nutrition therapy is the mainstay of treatment for GDM, however, there is no current consensus on the optimal dietary approaches for prevention and management of hyperglycemia during pregnancy. Our objective is to assess the relationship of plant-based diets, foods, and dietary supplements with GDM and maternal glycemic biomarkers in observational and clinical studies. Methods A systematic review was performed using PubMed to identify original articles from 1999–2019 following the PRISMA checklist statement. Articles were excluded if they were review articles, conference abstracts, not in English or did not meet the pre-defined PICOS (Population, Intervention/exposure, Comparison, Outcome, Study design) criteria. Articles were screened for relevance, extracted and summarized, and assessed for risk of bias and quality. Results A total of 431 articles were screened, 33 observational studies (prospective cohort: n = 26, case-control: n = 3, cross-sectional: n = 4) involving 147,576 women and 11 randomized clinical trials involving 3940 women were included. Among the observational studies, Mediterranean diet (MedDiet), fiber, and vegetable rich diets were associated with a significant decrease in GDM risk. Among the clinical trials, Dietary Approaches to Stop Hypertension (DASH) diet, MedDiet, soy, phytosterol spread, evening primrose, chili powder and a traditional Chinese herb, Artemisia scoparia Waldst. & Kit. (Asteraceae) (n = 1) exhibited improved maternal hyperglycemia, insulin resistance or sensitivity, and hypoadiponectinemia. Conclusions These findings suggest that plant-based diets may be effective in preventing and managing hyperglycemia during pregnancy. Particularly, adherence to a MedDiet may improve maternal glycemic biomarker and decrease risk of GDM. Funding Sources UNLV Faculty research start up award.

Clinical research in surgical oncology: An analysis of clinicaltrials.gov.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 591-591 ◽  
Author(s):  
Amber S Menezes ◽  
Alison Barnes ◽  
Adena S Scheer ◽  
Husein Moloo ◽  
Robin P Boushey ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Surgical Techniques ◽  
Surgical Oncology ◽  
The United States ◽  
Diagnostic Methods ◽  
Phase Iii ◽  
Medical Specialties ◽  
Surgical Interventions ◽  
Adjuvant Therapies

591 Background: The conduction of randomized clinical trials has expanded in medical specialties, but to a far lesser degree in surgery. This is due to design challenges with standardization of treatment, blinding and lack of surgeon equipoise. The objective of this study was to assess the current landscape of clinical trials in surgical oncology registered at clinicaltrials.gov. Methods: Data was extracted from clinicaltrials.gov using the following search engine criteria: ‘Cancer’ as Condition, ‘Surgery OR Operation OR Resection’ as Intervention, and Non-Industry sponsored. The search was limited to Canada and the United States and included trials registered from January 1, 2001 to January 1, 2011. The search was performed on March 23, 2011 by three investigators in parallel. The total number of oncology trials was also obtained. Results: Of 9990 oncology trials, 1049 (10.5%) included any type of surgical intervention. Of these trials, 125 (11.9%; 1.3% of all oncology trials) manipulated a surgical variable, 773 (73.7%) assessed adjuvant/neoadjuvant therapies, and 151 (14.4%) were observational studies. Trials assessing adjuvant therapies focused on systemic treatment (362 trials, 46.8%) and multimodal therapy (129 trials, 16.7%). Of the 125 trials where surgery was the manipulated variable, 59 trials (47.2%) focused on surgical techniques (including minimally invasive) or devices, 45 trials (36.0%) studied invasive diagnostic methods, and 21 trials (16.8%) evaluated surgery vs. no surgery. The majority of the 125 trials were non- randomized (72, 57.6%), and Phase III trials accounted for less than one-quarter (29, 23.2%). Conclusions: The number of registered surgical oncology trials is small in comparison to oncology trials as a whole. Clinical trials specifically designed to assess surgical interventions are vastly outnumbered by trials focusing on adjuvant therapies, and are frequently non-randomized. Randomized surgical oncology trials account for <1% of all registered cancer trials. Barriers to the design and implementation of randomized trials in surgical oncology need to be clarified to facilitate higher-level evidence in surgical decision making.

Participation in Surgical Oncology Clinical Trials: Gender-, Race/Ethnicity-, and Age-based Disparities

2007 ◽  
Vol 14 (12) ◽  
pp. 3328-3334 ◽  
Author(s):  
John H. Stewart ◽  
Alain G. Bertoni ◽  
Jennifer L. Staten ◽  
Edward A. Levine ◽  
Cary P. Gross
Keyword(s):  
Clinical Trials ◽  
Surgical Oncology ◽  
Oncology Clinical Trials ◽  
Race Ethnicity

scholarly journals Identifying competing interest disclosures in systematic reviews of surgical interventions and devices: a cross-sectional survey

2020 ◽  
Author(s):  
Jiajie Yu ◽  
Guanyue Su ◽  
Allison Hirst ◽  
Zengyue Yang ◽  
You Zhang ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Descriptive Analysis ◽  
Cross Sectional Survey ◽  
Chi Square ◽  
Cross Sectional ◽  
Surgical Interventions ◽  
Competing Interests ◽  
Funding Sources ◽  
Research Fields ◽  
Competing Interest

Abstract Background: A competing interest is an important source of bias in research and disclosure is frequently employed as a strategy to manage it. Considering the importance of systematic reviews (SRs) and the varying prevalence of competing interests in different research fields, we conducted a survey to identify the range of competing interests in SRs assessing surgical interventions or devices and explored the association between the competing interest disclosures and authors’ conclusions.Methods: We retrieved SRs of surgical interventions and devices published in 2017 via PubMed. Information regarding general characteristics, funding sources, and competing interest disclosures were extracted. We conducted a descriptive analysis of the studies’ characteristics and compared them between Cochrane SRs (CSRs)and non-Cochrane SRs using the Chi-square test. Results were expressed as odds ratio and their 95% confidence interval.Results: 155 SRs published in 2017 were included in the study. More than half of the SRs (58.7%) reported their funding sources and 94.2% reported authors’ competing interest disclosures. Among 146 SRs that stated competing interest disclosures, only 35 (22.6%) SRs declared at least one author had a competing interest. More than 40 terms were used to describe competing interests. Cochrane SRs (CSRs) were more likely to provide a detailed description of competing interests compared to those in non-CSRs (48.0% versus 25.4%, P=0.023). No association between positive conclusions and competing interest disclosures was found (P=0.484, OR=0.43, 95%CI: 0.08, 2.16). In the subgroup analyses, SRs stating no competing interest disclosure were more likely to report positive conclusions than those stating at least one type of competing interest, but the difference is not significantly different (P=0.406, OR=1.38, 95%CI: 0.64, 2.98)Conclusion: In surgical SRs, there is a high percentage of competing interest disclosures but without detailed information. The identification and statement of competing interests with a detailed description, particularly the non-financial ones, needs improvement. Some efficient and effective methods/tools for identifying, quantifying, and minimizing potential competing interests in systematic reviews remains valuable.

scholarly journals Characteristics of funding of clinical trials: cross-sectional survey and proposed guidance

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e015997 ◽  
Author(s):  
Maram B Hakoum ◽  
Nahla Jouni ◽  
Eliane A Abou-Jaoude ◽  
Divina Justina Hasbani ◽  
Elias A Abou-Jaoude ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Future Research ◽  
Funding Source ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Surgical Interventions ◽  
For Profit ◽  
Not For Profit ◽  
Funding Information ◽  
Randomised Controlled

ObjectivesTo provide a detailed and current characterisation of funding of a representative sample clinical trials. We also aimed to develop guidance for standardised reporting of funding information.MethodsWe addressed the extent to which clinical trials published in 2015 in any of the 119 Core Clinical Journals included a statement on the funding source (eg, whether a not-for-profit organisation was supported by a private-for-profit organisation), type of funding, amount and role of funder. We used a stepwise approach to develop a guidance and an instrument for standardised reporting of funding information.ResultsOf 200 trials, 178 (89%) included a funding statement, of which 171 (96%) reported being funded. Funding statements in the 171 funded trials indicated the source in 100%, amount in 1% and roles of funders in 50%. The most frequent sources were governmental (58%) and private-for-profit (40%). Of 54 funding statements in which the source was a not-for-profit organisation, we found evidence of undisclosed support of those from private-for-profit organisation(s) in 26 (48%). The most frequently reported roles of funders in the 171 funded trials related to study design (42%) and data analysis, interpretation or management (41%). Of 139 randomised controlled trials (RCTs) addressing pharmacological or surgical interventions, 29 (21%) reported information on the supplier of the medication or device. The proposed guidance addresses both the funding information that RCTs should report and the reporting process. Attached to the guidance is a fillable PDF document for use as an instrument for standardised reporting of funding information.ConclusionAlthough the majority of RCTs report funding, there is considerable variability in the reporting of funding source, amount and roles of funders. A standardised approach to reporting of funding information would address these limitations. Future research should explore the implications of funding by not-for-profit organisations that are supported by for-profit organisations.

scholarly journals 66: Early discontinuation and results reporting in obstetric clinical trials: An analysis of 3317 clinicaltrials.gov investigations

2020 ◽  
Vol 222 (1) ◽  
pp. S55-S56
Author(s):  
Brannon Weeks ◽  
Jecca R. Steinberg ◽  
Brandon Turner ◽  
Griselda Reyes ◽  
Alison A. Conway ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Early Discontinuation ◽  
Results Reporting

scholarly journals Natural language processing for patient selection in phase I/II oncology clinical trials

2021 ◽  
Author(s):  
Julie Delorme ◽  
Valentin Charvet ◽  
Muriel Wartelle ◽  
François Lion ◽  
Bruno Thuillier ◽  
...  
Keyword(s):  
Machine Learning ◽  
Clinical Trials ◽  
Phase I ◽  
Language Processing ◽  
Early Phase ◽  
Free Text ◽  
Tumor Type ◽  
Early Discontinuation ◽  
Promising Tool ◽  
Oncology Clinical Trials

AbstractPurposeEarly discontinuation affects over one-third of patients enrolled in early-phase oncology clinical trials. Early discontinuation is deleterious both for the patient and for the study, by inflating its duration and associated costs. We aimed at predicting the successful screening and dose-limiting toxicity period completion (SSD) from automatic analysis of consultation reports.Materials and methodsWe retrieved the consultation reports of patients included in phase I and/or phase II oncology trials for any tumor type at Gustave Roussy, France. We designed a pre-processing pipeline that transformed free-text into numerical vectors and gathered them into semantic clusters. These document-based semantic vectors were then fed into a machine learning model that we trained to output a binary prediction of SSD status.ResultsBetween September, 2012 and July, 2020, 56,924 consultation reports were used to build the dictionary, and 1,858 phase I/II inclusion reports were used to train (75%), validate (15%) and test (15%) a Random Forest model. Pre-processing could efficiently cluster words with semantic proximity. On the unseen test cohort of 264 consultation reports, the performances of the model reached: F1 score 0.80, recall 0.81 and AUC 0.88. Using this model, we could have reduced the screen fail rate (including DLT period) from 39.8% to 12.8% (RR=0.322, 95%CI[0.209-0.498], p<0.0001) within the test cohort. Most important semantic clusters for predictions comprised words related to hematological malignancies, anatomo-pathological features and laboratory and imaging interpretation.ConclusionMachine learning with semantic conservation is a promising tool to assist physicians in selecting patients prone to achieve SSD in early-phase oncology clinical trials.

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