scholarly journals Evaluation of Oncology Trial Results Reporting Over a 10-Year Period

2021 ◽  
Vol 4 (5) ◽  
pp. e2110438
Author(s):  
Xu Liu ◽  
Yuan Zhang ◽  
Wen-Fei Li ◽  
Everett Vokes ◽  
Ying Sun ◽  
...  
Keyword(s):  
Oncology Trial ◽  
Results Reporting

scholarly journals Cross-sectional study of preprints and final journal publications from COVID-19 studies: discrepancies in results reporting and spin in interpretation

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e051821
Author(s):  
Lisa Bero ◽  
Rosa Lawrence ◽  
Louis Leslie ◽  
Kellia Chiu ◽  
Sally McDonald ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Journal Publication ◽  
Reporting Practices ◽  
Subgroup Analyses ◽  
Journal Publications ◽  
Study Characteristics ◽  
Results Reporting

ObjectiveTo compare results reporting and the presence of spin in COVID-19 study preprints with their finalised journal publications.DesignCross-sectional study.SettingInternational medical literature.ParticipantsPreprints and final journal publications of 67 interventional and observational studies of COVID-19 treatment or prevention from the Cochrane COVID-19 Study Register published between 1 March 2020 and 30 October 2020.Main outcome measuresStudy characteristics and discrepancies in (1) results reporting (number of outcomes, outcome descriptor, measure, metric, assessment time point, data reported, reported statistical significance of result, type of statistical analysis, subgroup analyses (if any), whether outcome was identified as primary or secondary) and (2) spin (reporting practices that distort the interpretation of results so they are viewed more favourably).ResultsOf 67 included studies, 23 (34%) had no discrepancies in results reporting between preprints and journal publications. Fifteen (22%) studies had at least one outcome that was included in the journal publication, but not the preprint; eight (12%) had at least one outcome that was reported in the preprint only. For outcomes that were reported in both preprints and journals, common discrepancies were differences in numerical values and statistical significance, additional statistical tests and subgroup analyses and longer follow-up times for outcome assessment in journal publications.At least one instance of spin occurred in both preprints and journals in 23/67 (34%) studies, the preprint only in 5 (7%), and the journal publications only in 2 (3%). Spin was removed between the preprint and journal publication in 5/67 (7%) studies; but added in 1/67 (1%) study.ConclusionsThe COVID-19 preprints and their subsequent journal publications were largely similar in reporting of study characteristics, outcomes and spin. All COVID-19 studies published as preprints and journal publications should be critically evaluated for discrepancies and spin.

Scenarios to improve CT head utilization in the emergency department delineated by critical results reporting

2021 ◽  
Author(s):  
Long H. Tu ◽  
Arjun K. Venkatesh ◽  
Ajay Malhotra ◽  
Richard A. Taylor ◽  
Kevin N. Sheth ◽  
...  
Keyword(s):  
Emergency Department ◽  
Ct Head ◽  
Results Reporting ◽  
Critical Results

scholarly journals Ethical considerations of neuro-oncology trial design in the era of precision medicine

2017 ◽  
Vol 134 (1) ◽  
pp. 1-7 ◽  
Author(s):  
Saksham Gupta ◽  
Timothy R. Smith ◽  
Marike L. Broekman
Keyword(s):  
Precision Medicine ◽  
Trial Design ◽  
Ethical Considerations ◽  
Oncology Trial

scholarly journals Immuno-oncology Trial Endpoints: Capturing Clinically Meaningful Activity

2017 ◽  
Vol 23 (17) ◽  
pp. 4959-4969 ◽  
Author(s):  
Valsamo Anagnostou ◽  
Mark Yarchoan ◽  
Aaron R. Hansen ◽  
Hao Wang ◽  
Franco Verde ◽  
...  
Keyword(s):  
Meaningful Activity ◽  
Oncology Trial ◽  
Trial Endpoints

scholarly journals Analisis Biaya Cadangan Risiko Pinjaman dan Cadangan Risiko Pinjaman Dalam Laporan Auditor Independen Unit Pengelola Keuangan (Studi Kasus: Badan Keswadayaan Masyarakat di Kabupaten Bantul Provinsi DIY)

2016 ◽  
Vol 4 (2) ◽  
Author(s):  
Kurniawan Kurniawan ◽  
Dody Hapsoro
Keyword(s):  
Financial Reporting ◽  
Public Accounting ◽  
Loan Risk ◽  
Audit Result ◽  
Results Reporting ◽  
Almost All ◽  
The Cost ◽  
Keywords Cost

This study examines whether there are differences in the cost of the loan risk reserves and the loan risk reserves between audit results data and financial reporting. The research sample consisted of the audit results report on 50 BKM (Badan Keswadayaan Masyarakat) in Kabupaten Bantul Provinsi Daerah IstimewaYogyakarta whichhave been audited by Budiman, Wawan, Pamudji and Partners Public Accounting Firmin 2014. This study found that the cost of the loan risk allowances and loan risk allowances between audit result and reporting differed significantly. The study concluded that almost all of BKM not charge cost and reserve risk of the loan according collectibility list that is used as the source of the audit resultscalculation. Keywords: Cost of the loan risk reserves, loan risk reserves, audit results, reporting.

scholarly journals FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results

2018 ◽  
Author(s):  
Nicholas J. DeVito ◽  
Seb Bacon ◽  
Ben Goldacre
Keyword(s):  
Clinical Trials ◽  
Relevant Information ◽  
Reporting Requirements ◽  
Practical Support ◽  
The Us ◽  
Us Government ◽  
Results Reporting ◽  
And Performance ◽  
Legal Frameworks ◽  
Clinical Trial Results

AbstractIntroductionNon-publication of clinical trials results is an ongoing issue. In 2016 the US government updated the results reporting requirements to ClinicalTrials.gov for trials covered under the FDA Amendments Act 2007. We set out to develop and deliver an online tool which publicly monitors compliance with these reporting requirements, facilitates open public audit, and promotes accountability.MethodsWe conducted a review of the relevant legislation to extract the requirements on reporting results. Specific areas of the statutes were operationalized in code based on the results of our policy review, publicly available data from ClinicalTrials.gov, and communications with ClinicalTrials.gov staff. We developed methods to identify trials required to report results, using publicly available registry data; to incorporate additional relevant information such as key dates and trial sponsors; and to determine when each trial became due. This data was then used to construct a live tracking website.ResultsThere were a number of administrative and technical hurdles to successful operationalization of our tracker. Decisions and assumptions related to overcoming these issues are detailed along with clarifications directly from ClinicalTrials.gov. The FDAAA TrialsTracker was successfully launched in February 2018 and provides users with an overview of results reporting compliance.DiscussionClinical trials continue to go unreported despite numerous guidelines, commitments, and legal frameworks intended to address this issue. In the absence of formal sanctions from the FDA and others, we argue tools such as ours - providing live data on trial reporting - can improve accountability and performance. In addition, our service helps sponsors identify their own individual trials that have not yet reported results: we therefore offer positive practical support for sponsors who wish to ensure that all their completed trials have reported.

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]

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