Disparities in government and nonprofit organization funding may hinder clinical trial development for underfunded cancers.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1573-1573
Author(s):  
Suneel Deepak Kamath
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pearson Correlation ◽  
Nonprofit Organization ◽  
Correlation Coefficients ◽  
Descriptive Statistics ◽  
Incidence And Mortality ◽  
High Incidence ◽  
Uterine Cancers ◽  
Disease Specific

1573 Background: National Cancer Institute (NCI) and nonprofit organization (NPO) funding is critical for research and advocacy, but may not be equitable across cancers. This could negatively impact clinical trial development for underfunded cancers. Methods: This study evaluated funding from the NCI and NPOs with > $5 million in annual revenue supporting leukemia, lymphoma, melanoma, lung, breast, colorectal, pancreatic, hepatobiliary, prostate, ovarian, cervical and endometrial cancers from 2015-2018 based on publically available reports and tax records. The primary objectives were to assess for disparities in NCI and NPO funding across different cancers compared to their median incidence and mortality from 2015-2018, and to determine if underfunding correlates with fewer clinical trials found in clinicaltrials.gov. Correlations between combined NCI and NPO funding for each cancer and its incidence, mortality and number of clinical trials were evaluated using descriptive statistics and Pearson correlation coefficients. Results: Diseases with the largest combined NCI+NPO funding were breast ($3.75 billion), leukemia ($1.99 billion) and lung cancer ($1.56 billion). Those with the least funding were endometrial ($94 million), cervical ($292 million), and hepatobiliary cancers ($348 million). These data are summarized in the Table. Disease-specific NCI+NPO funding correlated well with incidence, but less so with mortality (Pearson correlation coefficients: 0.74 and 0.63, respectively). Disease-specific NPO funding correlated moderately well with incidence, but was poorly correlated with mortality (Pearson correlation coefficients: 0.54 and 0.39, respectively). Breast cancer, leukemia and lymphoma were consistently well-funded compared to their incidence and mortality, while colorectal, lung, hepatobiliary and uterine cancers were consistently underfunded. The amount of NCI funding, NPO funding and combined NCI+NPO funding for a particular cancer each correlated strongly with the number of clinical trials for that disease (Pearson correlation coefficients: 0.88, 0.87 and 0.91, respectively). Conclusions: Many cancers with high incidence and mortality are underfunded. Cancers with higher mortality rates receive less funding, particularly from NPOs. Underfunding strongly correlates with fewer clinical trials, which could impede future advances in underfunded cancers.[Table: see text]

An Analysis of Potentially Prolactin-Related Adverse Events and Abnormal Prolactin Values in Randomized Clinical Trials with Paliperidone Palmitate

2012 ◽  
Vol 46 (10) ◽  
pp. 1322-1330 ◽  
Author(s):  
Thomas R Einarson ◽  
Michiel EH Hemels ◽  
Isaac Nuamah ◽  
Srihari Gopal ◽  
Danielle Coppola ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Descriptive Statistics ◽  
Paliperidone Palmitate ◽  
Serum Prolactin ◽  
Clinical Trial Database ◽  
Long Acting ◽  
Monthly Dose

Background: Paliperidone palmitate has been associated with serum prolactin elevations in some patients. However, few individuals with elevated prolactin levels (hyperprolactinomia) have symptomatic potentially prolactin-related adverse events (PPR-AEs). Objective: To quantify rates of hyperprolactinemia in subjects treated with the newly marketed paliperidone palmitate long-acting injection (PP-LAI) in randomized clinical trials, summarize rates of PPR-AEs in those trials by sex and dose, and determine how many PPR-AEs required treatment. Methods: Numbers and rates of investigator-reported hyperprolactinemia and PPR-AEs wore obtained from the sponsor's clinical trial database and have been included in regulatory filings. Results were tabulated for males, females, and overall, and by dose administered, using descriptive statistics. Those requiring treatment were described as well. Results: There were 3173 subjects (61.4% males) exposed to PP-LAI in 10 clinical trials; 2831 (89.2%) patients had recorded prolactin levels, including 1759 males (90, 3% of exposed males) and 1072 females (87.5% of exposed females). Overall, at any time, prolactin levels were elevated for 38.8% of the subjects (39.5% for males and 37.7% for females; p = 0.354 between sexes). However, them was no significant correlation between monthly dose and proportion of subjects with elevated prolactin levels (p = 0.109). There were 115 PPR-AEs in 107 patients (3.4%); 51 (44.3% of PPR-AEs) cases represented asymptomatic hyperprolactinemia. The remaining 64 symptomatic PPR-AEs affected 2.0% of the total number of subjects. Fifteen events in 13 participants (0.41% of patients or 4.7 events/1000 patients) required treatment. Conclusions: Clinicians should periodically assess patients on paliperidone palmitate for any PPR-AEs and carefully assess the benefits and risks when managing these effects.

scholarly journals Inwestycja w wino – ocena sommelierów, rocznik i liczba punktów dystrybucji a wycena

2015 ◽  
Vol 3 (3) ◽  
pp. 173-188
Author(s):  
Marcin Potrykus
Keyword(s):  
Pearson Correlation ◽  
Correlation Coefficients ◽  
Econometric Models ◽  
Descriptive Statistics ◽  
Average Price ◽  
Average Change

The paper uses Pearson correlation coefficients to analyze strength and directionof the interaction between: price of the wine and the vintage, the evaluationmade by sommeliers and wine price, price of wine and number of distributionpoints. Eight wine strains from the region of Bordeaux were analyzed. The strongestassociation was observed between the price of wine and vintage. The articlealso presents selected descriptive statistics for the price of wine, the assessmentprovided by sommeliers and the number of distribution points. On average, winecalled Petrus / Pomerol enjoys the highest recognition of sommeliers. Furthermore,estimated econometric models indicate that the average price of the analyzedstrains increased by 2.46% a year while the change in the evaluation of wine byone point affects the average change in price by 6.01%.

EPID-11. A POPULATION STUDY OF CLINICAL TRIAL ACCRUAL FOR WOMEN AND MINORITIES IN NEURO-ONCOLOGY FOLLOWING THE NIH REVITALIZATION ACT

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi88-vi88
Author(s):  
Sheantel Reihl ◽  
Nirav Patil ◽  
Ramin Morshed ◽  
Mulki Mehari ◽  
alexander Aabedi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Disease Incidence ◽  
Population Based ◽  
World Health ◽  
Mortality Data ◽  
Incidence And Mortality ◽  
Clinical Trial Accrual ◽  
Expected Mortality ◽  
Study Participants

Abstract INTRODUCTION The NIH Revitalization Act, implemented 29 years ago, set to improve the representation of women and minorities in clinical trials. In this study, we investigate the progress made in neuro-oncology in all phase therapeutic clinical trials for neuro-epithelial central nervous system tumors in comparison to their demographic-specific age-adjusted disease incidence and mortality. METHODS Registry study of all published clinical trials for World Health Organization (WHO) defined neuro-epithelial CNS tumors between January 2000 and December 2019. Study participants for trials were obtained from PubMed and ClinicalTrials.gov. Population-based data from the CBTRUS for incidence analyses. SEER-18 Incidence-Based Mortality data was used for mortality analysis. Descriptive statistics, Fisher exact, and c2 tests were used to analyze the data. RESULTS Among 662 published clinical trial articles representing 49, 907 accrued participants, 62.5% of study participants were men and 37.5% were women (P< 0.0001) representing a mortality specific over-accrual for men (P= 0.001) and under-accrual for women (P= 0.001). Whites, Asians, Blacks, and Hispanics represented 91.7%, 1.5%, 2.6%, and 1.7% of trial participants. Compared with their US cancer mortality, Blacks (47% of expected mortality, P=.008), Hispanics (17% of expected mortality, P< .001) and Asians (33% of expected mortality, P< .001) were underrepresented compared with Whites (114% of expected mortality, P< .001). CONCLUSIONS Nearly 30 years since the Revitalization Act, minorities and women are consistently underrepresented when compared with their demographic-specific incidence and mortality in therapeutic clinical trials for neuroepithelial tumors. This study provides a framework for investigating cancer clinical trial accrual and offers guidance regarding workforce factors associated with enrollment of vulnerable patients.

scholarly journals Operational Strategies for Clinical Trials in Africa

2020 ◽  
pp. 973-982
Author(s):  
Katy M. Graef ◽  
Ifeoma Okoye ◽  
Naomi O. Ohene Oti ◽  
Jennifer Dent ◽  
Folakemi T. Odedina
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
Operational Strategies ◽  
Patients With Cancer ◽  
Engagement Strategies ◽  
African Health ◽  
Incidence And Mortality ◽  
African Patients ◽  
Current Clinical Trial

PURPOSE In a dramatic reversal of longstanding trends, cancer now kills more Africans than malaria. Despite Africa’s growing cancer burden, individuals of African descent, notably those residing in Africa, remain drastically under-represented in cancer clinical trials. Two recent summits—the 1st All Africa Clinical Trial Summit and the Operational Strategy for Clinical Trials in Nigeria Summit—convened experts from governments, the private sector, universities, and professional societies to define the barriers to Africa’s participation in multicenter clinical studies and the strategies to eliminate those impedances. METHODS The discussions held during the two clinical trial summits were condensed into a set of 10 recommendations covering five broad categories (funding, regulation, capacity building, Africa-centric approach, and patient engagement). In this article, four programs are presented as examples of how the summits’ recommendations can be put into practice to improve Africa’s ability to attract clinical trials, in particular, cancer clinical trials. RESULTS These example programs all leveraged a multilateral, Africa-driven approach to building Africa’s clinical trial capacity, increasing visibility of Africa’s current clinical trial capabilities and priorities, improving regulatory infrastructure and enforcement on the continent, and optimizing patient and clinician engagement strategies. CONCLUSION The four programs are anticipated to catalyze the involvement of more African health care sites in cancer clinical trials, enroll a greater number of African patients with cancer in those trials, and, ultimately, reverse Africa’s growing cancer incidence and mortality rates. Each program acts as a blueprint for organizations—whether government, academic, or industry—seeking to address the summits’ recommendations and increase Africa’s contributions to and active participation in clinical research.

Comparison and Validation of Preoperative Planning Techniques for Distal Femoral Osteotomies and Proximal Tibial Osteotomies

2020 ◽  
Author(s):  
David T. Zhang ◽  
Peter S. Principe ◽  
Austin T. Fragomen ◽  
S Robert Rozbruch
Keyword(s):  
Current Practice ◽  
Preoperative Planning ◽  
Pearson Correlation ◽  
Intraclass Correlation ◽  
Correlation Coefficients ◽  
Descriptive Statistics ◽  
Planning Techniques ◽  
Future Studies ◽  
Intraclass Correlation Coefficients ◽  
Accepted Standard

AbstractPreoperative planning is important for accurate intraoperative execution in many surgical fields. Planning for distal femoral osteotomies (DFOs) and proximal tibial osteotomies (PTOs) consists of choosing the level of the osteotomy, measuring the angle of the osteotomy based on hip-knee-ankle alignment, and choosing a proper osteotomy wedge size. Medical imaging IT solutions company Sectra has implemented a new osteotomy tool in their radiographic system that is simpler than the accepted standard of modified center of rotation of angulation (mCORA) technique, yet unvalidated. In this study, we aim to compare the Sectra osteotomy tool versus the mCORA technique to measure the osteotomy angles as well as wedge sizes in both DFOs and PTOs to validate this new tool.We enrolled n = 30 consecutive patients with DFOs and n = 30 PTOs from the last year. The Pearson correlation coefficient (PCC) along with descriptive statistics was used to evaluate for similarity between the two techniques. We also compared interobserver and intraobserver reliability using intraclass correlation coefficients (ICC).The PCC for osteotomy angles in DFOs and PTOs were both 0.998 (p < 0.001 for both). For wedge sizes, the PCC in DFOs was 0.993 and 0.980 in PTOs (p < 0.001 for both). ICCs were high for both interobserver measurements in osteotomy angles and wedge sizes (range: 0.989–0.999) as well as intraobserver measurements (0.994–0.999).The Sectra osteotomy tool is a validated tool for preoperative measurements of DFOs and PTOs. It is reliable and simpler than the current practice of the mCORA technique. We suggest future studies to analyze this Sectra osteotomy tool in other settings as to incorporate it into widespread clinical use.

scholarly journals Methods for detection of clusters of observations with an outlying correlation coefficient value

2020 ◽  
Author(s):  
Lieven Desmet ◽  
David Venet ◽  
Laura Trotta ◽  
Tomasz Burzykowski ◽  
Marc Buyse
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Correlation Coefficient ◽  
Simulation Study ◽  
Real Life ◽  
Correlation Coefficients ◽  
Multicenter Clinical Trial ◽  
Bivariate Data ◽  
Statistical Monitoring ◽  
Central Statistical

AbstractMultivariate datasets with a clustered structure are the natural framework for, e.g., multicentre clinical trials. We propose a number of methods aimed at detecting clusters with outlying correlation coefficients. While the methods can be used in a variety of settings, we focus mainly on their application to central statistical monitoring of clinical trials. In particular, we consider the issue of detecting centers (or other clusters of patients such as regions) with outlying correlation coefficients for bivariate data in a multicenter clinical trial. It appears that, in that context, the proposed methods perform well, as we show by using a simulation study and a number of real life datasets.

scholarly journals Assessment of clinical trials registered at clinical trial registry of India over past decade: an audit

2016 ◽  
Vol 3 (4) ◽  
pp. 238 ◽  
Author(s):  
Shruti S Bhide ◽  
Firoz Tadvi ◽  
Mitesh Maurya ◽  
Sunil Bhojne ◽  
Pragya Chandrakar
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Clinical Research ◽  
Clinical Studies ◽  
Descriptive Statistics ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Post Graduate ◽  
The Past

<p class="abstract"><strong>Background:</strong> Clinical trial registry of India (CTRI) was launched in 2007. In this audit we attempted to assess the clinical research scenario over the past decade by looking at the information about clinical studies registered at the CTRI from 2007 to 2016.</p><p class="abstract"><strong>Methods:</strong> We accessed the official website of the CTRI i.e. www.ctri.nic.in and the required information was downloaded and descriptive statistics were used.</p><p class="abstract"><strong>Results:</strong> We found that the number of studies went on increasing from 31 in 2007 to 7060 in 2016 (as on 22<sup>nd</sup> June 2016). Majority studies were of interventional in nature as compared to observational and bioavailability and bioequivalence (BABE) studies. Pharmaceutical industry sponsored studies were comparatively higher in number than any other sponsored studies. However their number went on decreasing, while increase in registration of post graduate thesis and investigator sponsored studies was observed.</p><p><strong>Conclusions:</strong> Though a decrease in Pharmaceutical industry sponsored studies was observed the overall clinical research scenario appears to have improved due to investigator initiated studies and post graduate thesis.</p>

scholarly journals Are orthodontic randomised controlled trials justified with a citation of an appropriate systematic review?

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kishan Patel ◽  
Martyn T. Cobourne ◽  
Nikolaos Pandis ◽  
Jadbinder Seehra
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Logistic Regression ◽  
Randomised Controlled Trials ◽  
Descriptive Statistics ◽  
Controlled Trials ◽  
Eligibility Criteria ◽  
Study Characteristics ◽  
Randomised Controlled

Abstract Background A systematic review of the evidence should be undertaken to support the justification for undertaking a clinical trial. The aim of this study was to examine whether reports of orthodontic Randomised Clinical Trials (RCTs) cite prior systematic reviews (SR) to explain the rationale or justification of the trial. Study characteristics that predicated the citation of SR in the RCT report were also explored. Material and methods Orthodontic RCTs published between 1st January 2010 to 31st December 2020 in seven orthodontic journals were identified. All titles and abstracts were screened independently by two authors. Descriptive statistics and associations were assessed for the study characteristics. Logistic regression was used to identify predicators of SR inclusion in the trial report. Results 301 RCTs fulfilling the eligibility criteria were assessed. 220 SRs were available of which 74.5% (N = 164) were cited, and 24.5% (N = 56) were not included but were available in the literature within 12 months of trial commencement. When a SR was not included in the introduction or no SR was available within 12 months of trial commencement, interventional studies were commonly cited. The continent of the corresponding author predicated the possibility of inclusion of a SR in the introduction (OR 0.36; 95% CI 0.18–0.71; p = 0.003). Conclusions A quarter of orthodontic RCTs (24.5%) included in this study did not cite a SR in the introduction section to justify the rationale of the trial when a relevant SR was available. To reduce research waste and optimal usage of resources, researchers should identify or conduct a systematic review of the evidence to support the rationale and justification of the trial.

scholarly journals A Population Study of Clinical Trial Accrual for Women and Minorities in Neuro-Oncology Following the NIH Revitalization Act

2021 ◽  
Author(s):  
Sheantel J Reihl ◽  
Nirav Patil ◽  
Ramin A. Morshed ◽  
Mulki Mehari ◽  
Alexander Aabedi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Disease Incidence ◽  
Cns Tumors ◽  
World Health ◽  
Mortality Data ◽  
Incidence And Mortality ◽  
Clinical Trial Accrual ◽  
Expected Mortality ◽  
Study Participants

BACKGROUND The NIH Revitalization Act, implemented 29 years ago, set to improve the representation of women and minorities in clinical trials. In this study, we investigate progress made in all phase therapeutic clinical trials for neuro-epithelial CNS tumors stratified by demographic-specific age-adjusted disease incidence and mortality. Additionally, we identify workforce characteristics associated with clinical trials meeting established accrual benchmarks. METHODS Registry study of published clinical trials for World Health Organization defined neuro-epithelial CNS tumors between January 2000 and December 2019. Study participants were obtained from PubMed and ClinicalTrials.gov. Population-based data originated from the CBTRUS for incidence analyses. SEER-18 Incidence-Based Mortality data was used for mortality analysis. Descriptive statistics, Fisher exact, and Chi2 tests were used for data analysis. RESULTS Among 662 published clinical trials representing 49,907 participants, 62.5% of study participants were men and 37.5% were women (P<0.0001) representing a mortality specific over-accrual for men (P=0.001). Whites, Asians, Blacks, and Hispanics represented 91.7%, 1.5%, 2.6%, and 1.7% of trial participants. Compared with mortality, Blacks (47% of expected mortality, P=0.008), Hispanics (17% of expected mortality, P<0.001) and Asians (33% of expected mortality, P<.001) were underrepresented compared with Whites (114% of expected mortality, P<0.001). Clinical trials meeting accrual benchmarks for race included minority authorship. CONCLUSIONS Following the Revitalization Act, minorities and women remain underrepresented when compared with their demographic-specific incidence and mortality in therapeutic clinical trials for neuroepithelial tumors. This study provides a framework for clinical trial accrual efforts and offers guidance regarding workforce considerations associated with enrollment of vulnerable patients.

Reliability of the Minimum Masking Level as Outcome Variable in Tinnitus Clinical Research

2020 ◽  
Vol 29 (3) ◽  
pp. 429-435
Author(s):  
Patricia C. Mancini ◽  
Richard S. Tyler ◽  
Hyung Jin Jun ◽  
Tang-Chuan Wang ◽  
Helena Ji ◽  
...  
Keyword(s):  
Standard Deviation ◽  
High Frequency ◽  
Pearson Correlation ◽  
Correlation Coefficients ◽  
Outcome Variable ◽  
Reliable Estimate ◽  
Moderate Correlation ◽  
Trained Subjects ◽  
The Relationship ◽  
Minimum Intensity

Purpose The minimum masking level (MML) is the minimum intensity of a stimulus required to just totally mask the tinnitus. Treatments aimed at reducing the tinnitus itself should attempt to measure the magnitude of the tinnitus. The objective of this study was to evaluate the reliability of the MML. Method Sample consisted of 59 tinnitus patients who reported stable tinnitus. We obtained MML measures on two visits, separated by about 2–3 weeks. We used two noise types: speech-shaped noise and high-frequency emphasis noise. We also investigated the relationship between the MML and tinnitus loudness estimates and the Tinnitus Handicap Questionnaire (THQ). Results There were differences across the different noise types. The within-session standard deviation averaged across subjects varied between 1.3 and 1.8 dB. Across the two sessions, the Pearson correlation coefficients, range was r = .84. There was a weak relationship between the dB SL MML and loudness, and between the MML and the THQ. A moderate correlation ( r = .44) was found between the THQ and loudness estimates. Conclusions We conclude that the dB SL MML can be a reliable estimate of tinnitus magnitude, with expected standard deviations in trained subjects of about 1.5 dB. It appears that the dB SL MML and loudness estimates are not closely related.

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