scholarly journals RECIST 1.1 and lesion selection: How to deal with ambiguity at baseline?

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Antoine Iannessi ◽  
Hubert Beaumont ◽  
Yan Liu ◽  
Anne-Sophie Bertrand
Keyword(s):  
Clinical Trials ◽  
Impact Analysis ◽  
Malignant Lesion ◽  
Evaluation Criteria ◽  
Ground Truth ◽  
Tumor Burden ◽  
Phase 3 ◽  
Oncology Clinical Trials ◽  
The Impact ◽  
Selection Of

AbstractResponse Evaluation Criteria In Solid Tumors (RECIST) is still the predominant criteria base for assessing tumor burden in oncology clinical trials. Despite several improvements that followed its first publication, RECIST continues to allow readers a lot of freedom in their evaluations. Notably in the selection of tumors at baseline. This subjectivity is the source of many suboptimal evaluations. When starting a baseline analysis, radiologists cannot always identify tumor malignancy with any certainty. Also, with RECIST, some findings can be deemed equivocal by radiologists with no confirmatory ground truth to rely on. In the specific case of Blinded Independent Central Review clinical trials with double reads using RECIST, the selection of equivocal tumors can have two major consequences: inter-reader variability and modified sensitivity of the therapeutic response. Apart from the main causes leading to the selection of an equivocal lesion, due to the uncertainty of the radiological characteristics or due to the censoring of on-site evaluations, several other situations can be described more precisely. These latter involve cases where an equivocal is selected as target or non-target lesions, the management of equivocal lymph nodes and the case of few target lesions. In all cases, awareness of the impact of selecting a non-malignant lesion will lead radiologists to make selections in the most rational way. Also, in clinical trials where the primary endpoint differs between phase 2 (response-related) and phase 3 (progression-related) trials, our impact analysis will help them to devise strategies for the management of equivocal lesions.

scholarly journals Indicadores (Outcomes) Primários e Secundários em Ensaios Clínicos Oncológicos: Definição e Usos

2014 ◽  
Vol 27 (4) ◽  
pp. 498
Author(s):  
António Vaz-Carneiro ◽  
Ricardo Da Luz ◽  
Margarida Borges ◽  
João Costa
Keyword(s):  
Clinical Trials ◽  
Methodological Issue ◽  
Objective Response ◽  
Disease Free Survival ◽  
Progression Free Survival ◽  
Free Survival ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Alternative Drug ◽  
Selection Of

<strong>Introduction:</strong> The proof of efficacy from a therapeutic intervention in oncology must be defined through well conducted clinical trials. One of the most important methodological issue is the outcome selection needed to calculate measures of association allowing definition of clinical efficacy.<br /><strong>Material and Methods:</strong> We designed a narrative revision based on some of the international regulatory instructions from drug agencies, as well as consensus papers from scientific oncology societies, listing and critically assessing each outcome used in oncology clinical trials.<br /><strong>Results:</strong> We identified as being the most important outcomes in oncology trials the overall survival, the progression free survival/ disease-free survival, the toxicity, the quality of life/patient- reported outcomes and the objective response rate.<br /><strong>Discussion:</strong> The selection of the primary outcome must be based on therapeutic efficacy as well as toxicity, expected survival, alternative drug regimens and even disease prevalence.<br /><strong>Conclusion:</strong> The selection of efficacy outcomes for clinical trials in oncology is very important and its selection must be well justified, and depends on the type of disease, the patients and the drug being studied.<br /><strong>Keywords:</strong> Clinical Trials as Topic; Neoplasms; Medical Oncology; Treatment Outcome.

scholarly journals Recent Advances in Saliency Estimation for Omnidirectional Images, Image Groups, and Video Sequences

2020 ◽  
Vol 10 (15) ◽  
pp. 5143
Author(s):  
Marco Buzzelli
Keyword(s):  
Evaluation Criteria ◽  
Visual Saliency ◽  
Ground Truth ◽  
Video Sequences ◽  
Domain Specific ◽  
Saliency Maps ◽  
Perceptual Property ◽  
Omnidirectional Images ◽  
Video Saliency ◽  
Selection Of

We present a review of methods for automatic estimation of visual saliency: the perceptual property that makes specific elements in a scene stand out and grab the attention of the viewer. We focus on domains that are especially recent and relevant, as they make saliency estimation particularly useful and/or effective: omnidirectional images, image groups for co-saliency, and video sequences. For each domain, we perform a selection of recent methods, we highlight their commonalities and differences, and describe their unique approaches. We also report and analyze the datasets involved in the development of such methods, in order to reveal additional peculiarities of each domain, such as the representation used for the ground truth saliency information (scanpaths, saliency maps, or salient object regions). We define domain-specific evaluation measures, and provide quantitative comparisons on the basis of common datasets and evaluation criteria, highlighting the different impact of existing approaches on each domain. We conclude by synthesizing the emerging directions for research in the specialized literature, which include novel representations for omnidirectional images, inter- and intra- image saliency decomposition for co-saliency, and saliency shift for video saliency estimation.

Baseline and change from baseline in tumor burden compared with patient outcomes

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17530-e17530
Author(s):  
L. Kaiser ◽  
J. Fridlyand ◽  
G. Fyfe
Keyword(s):  
Patient Outcomes ◽  
Positive Relationship ◽  
Objective Response ◽  
Tumor Burden ◽  
Cox Models ◽  
Strong Positive Relationship ◽  
Oncology Clinical Trials ◽  
The Impact ◽  
The Relationship ◽  
Negative Predictor

e17530 Background: The impact of baseline tumor burden (bTB) and percentage reduction in tumor burden (dTB) on patient outcome has not been systematically studied in oncology clinical trials. We assess the relationship between both bTB and dTB and objective response (OR), progression free and overall survival (PFS and OS) in bevacizumab (B) and trastuzumab (T) trials. Methods: We analyzed 3 B and 1 T Ph 3 mBC and mCRC trials of > 1800 patients total. We used correlations and Cox models for the relationships between pairs of variables and multivariate Cox models to evaluate TB and PFS as independent predictors of OS. Here, we present the minimum dTB value until progression. Results: bTB is not related to dTB, OR rate or PFS time; it is negatively related to OS. dTB shows a strong positive relationship with PFS and OS. TB and PFS are independent predictors of OS, with PFS the better predictor. Results at earlier dTB assessments and within treatment arms are similar. Conclusions: Patients with high bTB are equally likely to respond to treatment and to have prolonged PFS as those with lower bTB, but high bTB is a negative predictor for OS. In contrast, greater percentage reductions in TB are strongly associated with better PFS and OS outcomes. Tumor burden and PFS are independent predictors of OS. Owing to these relationships, assessing bTB and dTB, as well as OR, PFS and OS, may improve the interpretation of phase II data. [Table: see text] [Table: see text]

Current Status of Patient-Reported Outcomes in Industry-Sponsored Oncology Clinical Trials and Product Labels

2007 ◽  
Vol 25 (32) ◽  
pp. 5087-5093 ◽  
Author(s):  
Kathleen Gondek ◽  
Pierre-Philippe Sagnier ◽  
Kim Gilchrist ◽  
J. Michael Woolley
Keyword(s):  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Symptom Assessment ◽  
Current Status ◽  
Cancer Therapies ◽  
Package Inserts ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Related Quality ◽  
The Impact

Assessing patient-reported outcomes (PROs) in clinical trials is of interest to clinicians, patients, regulators, and industry. The use and impact of PROs is a growing area of methodologic research, particularly as they relate to tumor types, biomarkers, and various patient populations and cultures. Both the US Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products in recent guidance have acknowledged the need to account for treatment-related impact on patient symptoms and/or health-related quality of life (HRQOL). Clinical research likely reflects the informative value of PROs. A search of www.clinicaltrials.gov , the FDA Web site, and product package inserts was conducted to assess the inclusion of symptom assessment and HRQOL within industry-sponsored clinical trials in cancer and approved cancer therapies and their respective product labels. Overall, there were 2,704 industry-sponsored oncology trials, of which 322 (12%) included a PRO measure. Of the 70 FDA new or revised labels, only six package inserts include PRO data. Symptoms were assessed uniformly across the phases of clinical trials, whereas HRQOL assessment increased in the later phases of clinical trials. Collecting PRO data can enhance our understanding of cancer burden and the impact of interventions on patients' lives.

Invisible Barriers to Clinical Trials: The Impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials

2006 ◽  
Vol 24 (28) ◽  
pp. 4545-4552 ◽  
Author(s):  
David M. Dilts ◽  
Alan B. Sandler
Keyword(s):  
Clinical Trials ◽  
The United States ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Community Practice ◽  
Home Office ◽  
Scientific Review ◽  
Oncology Research ◽  
Oncology Clinical Trials ◽  
The Impact

Purpose To investigate the administrative barriers that impact the opening of clinical trials at the Vanderbilt-Ingram Cancer Center (VICC) and at VICC Affiliate Network (VICCAN) sites. Methods VICC, a National Cancer Institute–designated comprehensive cancer center, and three VICCAN community practice sites were studied. Methodology used was identification and mapping of existing processes and analysis of historical timing data. Results At course granularity, the process steps required at VICC and VICCAN main office plus local sites are 20 v 17 to 30 steps, respectively; this gap widens with finer granularity, with more than 110 v less than 60 steps, respectively. Approximately 50% of the steps are nonvalue added. For example, in the institutional review board (IRB) process, less than one third of the steps add value to the final protocol. The numbers of groups involved in the approval processes are 27 (VICC) and 6 to 14 (VICCAN home office and local sites). The median times to open a trial are 171 days (95% CI, 158 to 182 days) for VICC and 191 days (95% CI, 119 to 269 days) for the VICCAN sites. Contrary to expectations, the time for IRB review and approval (median, 47 days) is the fastest process compared with the scientific review committee review and approval (median, 70 days) and contracts and grants review (median, 78.5 days). Opening a cooperative group clinical trial is significantly (P = .05) more rapid because they require fewer review steps. Conclusion There are numerous opportunities to remove nonvalue-added steps and save time in opening clinical trials. With increasing numbers of new agents, fewer domestic principal investigators, and more companies off-shoring clinical trials, overcoming such barriers is of critical importance for maintenance of core oncology research capabilities in the United States.

scholarly journals THEORETICAL AND METHODOLOGICAL FUNDAMENTALS OF SELECTION OF AGROINNOVATIVE PROJECTS ON THE BASIS OF THEIR RISK ASSESSMENT

2020 ◽  
Vol 288 (6) ◽  
pp. 261-265
Author(s):  
L. Tesheva ◽  
◽  
V. Hryshchenko ◽  
Keyword(s):  
Risk Assessment ◽  
Quantitative Methods ◽  
Impact Analysis ◽  
Agricultural Sector ◽  
Inclusive Development ◽  
Economic Research ◽  
Use Of Resources ◽  
Qualitative Risk Assessment ◽  
The Impact ◽  
Selection Of

The focus on the simultaneous solution of social, economic and environmental problems allows to form programs of sustainable and inclusive development, which should be based on innovative projects that provide more efficient use of resources with higher returns, increase productivity, increase the level of intellectualization of production. A special feature of innovative projects is their high level of risk. This has a decisive influence on management decisions regarding their implementation. That is why risk assessment of innovative projects occupies a special place in the field of economic research. The purpose of the article is to substantiate the theoretical and methodological principles of selection of innovative projects by the subjects of the agricultural sector of the economy on the basis of the proposed methods of assessing their risk. It has been established that one of the key aspects of comparing projects and portfolios is risk consideration. The list of risk groups of innovative projects is established. It is proposed to use evaluation by quantitative methods (statistical, analytical, cost-effectiveness method, normative method) and qualitative (impact analysis, probability of loss analysis, expert method). As a result of evaluation, data sets are formed for each individual project, which include the values of quantitative indicators of the effects of agroinnovation, ranking values for qualitative parameters of achieving benefits, quantitative values of risks and integral value for qualitative risk assessment determined using fuzzy sets. The process of assessing the impact of risks on the qualitative parameters of the effects of the implementation of agro-innovative projects and the procedure for assessing the generalized impact of risks on all qualitative parameters on the project using the fuzzy set method are detailed. The implementation of the developed algorithm allows to ensure a synergistic effect from the interaction of agro-innovative projects in the process of ensuring the innovative development of the agricultural sector of Ukraine’s economy.

The impact of the inclusion of clinical data review on overall radiographic response and progression in oncology clinical trials as assessed by blinded independent central review

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6511-6511
Author(s):  
N. Wangler ◽  
K. Borradaile ◽  
R. Ford
Keyword(s):  
Breast Cancer ◽  
Colorectal Cancer ◽  
Clinical Trials ◽  
Clinical Review ◽  
Clinical Data ◽  
Study Endpoint ◽  
Primary Study ◽  
Best Response ◽  
Oncology Clinical Trials ◽  
The Impact

6511 Background: The United States Food and Drug Administration (USFDA) advocates blinded independent central review (BICR) of radiographic exams for oncology registration studies when the primary study endpoint is based on tumor measurements, such as progression-free survival, time to progression or objective response rate. However, a proportion of subjects progress clinically prior to radiographic evidence of disease progression and in certain indications, measurement of cutaneous lesions may be incorporated into response criteria calculations. Methods: BICR data from 4,183 subjects in the following indications: lymphoma, melanoma, breast cancer, and colorectal cancer, was blinded, pooled, and reviewed to determine the impact of clinical review on best response and date of progression following BICR of radiographic images. Results: Inclusion of clinical data and/or clinical photography impacted 27% (47/171) of lymphoma subjects, affecting the assessment of the best response (13%), best response date (16%) and/or the date of progression (19%); 12% (13/107) of melanoma subjects, affecting the assessment of the best response (6%), best response date (5%), and/or the date of progression (8%); 10% (308/2,947) of breast cancer subjects, affecting the assessment of the best response (4%), best response date (4%), and/or the date of progression (9%); 3% (32/958) of colorectal cancer subjects, affecting the assessment of the best response (2%), best response date (2%), and/or the date of progression (2%). Conclusions: When using BICR to determine endpoints in oncology clinical trials, inclusion of a clinical review may be relevant in 27% of subjects for lymphoma, 12% for melanoma, 10% for breast cancer, and 3% for colorectal cancer. [Table: see text]

A national survey on patients’ enrollment rate in oncology clinical trials: The French experience.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17567-e17567
Author(s):  
Iris Pauporte ◽  
Valerie Thibaudeau ◽  
Fabien M. Calvo ◽  
Agnes Buzyn
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Public Investment ◽  
University Hospitals ◽  
Public Intervention ◽  
Therapeutic Trials ◽  
Research Activities ◽  
Number Of Patients ◽  
Oncology Clinical Trials ◽  
The Impact

e17567 Background: The rate of patients enrolled in clinical trials (CT) is one of the main indicators of clinical research and care activity. The successive French Cancer Plans (2003-2007 and 2009-2013) aimed at quantifiable targets of patients to be enrolled in high-quality clinical trials. To help investigators achieving this objective, a substantial financial support for clinical research associates (CRA) recruitment was given to University Hospitals (UH), Comprehensive Cancer Centers (CCC) and public or private community hospitals (CH). In the meantime, significant public investment was allocated to competitively selected academic projects through the Clinical Research National Program. Methods: From 2006 to 2011, we carried out annual national surveys on clinical research activities in oncology in France. A questionnaire was sent to cancer care institutions. Number of CT open for enrolment, number of CT sponsored by the institution, number of patients enrolled and human resources (CRA) were collected. Academic and industry-sponsored trials were analyzed separately. Results: We showed that the number of patients enrolled in CT increased continuously over this period: from 21,500 in 2002 to 35,400 in 2011 (+47%). Based on these figures and assuming that there were 420,000 to 472,000 patients eligible for CT over this period, the enrolment rate for patients in CT is estimated to be 7.5 to 8.5% in 2011 versus 5.8 to 6.7% in 2003. Nearly 80% of all enrolled patients were recruited in academic CT; over 75% of patients in therapeutic trials. UH and CCC equally contributed for 80% of enrolment, CH for the residual 20%. At last, the number of CT increased by more than 35% over the same period, while the number of CRA was multiplied by 3 over the French territory. Conclusions: Our results show that public intervention for improving enrolment to cancer CT seems to be efficient. Other types of intervention are being considered, i.e., targeted on investigators, on patients, or on both. Future work should also consider the impact of CT enrolment on patients’ outcome.

Racial distribution of clinical trial participants in the United States.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18516-e18516
Author(s):  
Monaliben Patel ◽  
Lisa M. Hess ◽  
Eric Wen Su ◽  
Xiaohong Li ◽  
Debora S. Bruno
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Phase 2 ◽  
Phase 3 ◽  
Black Patients ◽  
The Us ◽  
Oncology Clinical Trials ◽  
Seer Data ◽  
Trial Participants

e18516 Background: Lack of diverse representation in clinical trials negatively impacts the cancer survival of patients and populations unaccounted for in clinical research. Efforts such as the 1993 NIH Revitalization Act have focused on improving the diversity of trial participants in the US. This retrospective study evaluated the racial distribution of oncology clinical trial participants using data published in clinicaltrials.gov from Jan 2010 through Dec 2020. Methods: I2E of Linguamatics (IQVIA, Inc), a natural language processing software, was used to identify participant race in oncology trials. Data extracted included trial identifier, year of completion, sponsor, cancer type, and race. Studies were limited to academic, cooperative group and government studies headquartered in the US. Clinical trial results were compared to the racial distribution of SEER 2010 data using z-test. Results: Data from 35,686 patients (14,220 enrolled to 236 phase 2 and 21,471 enrolled to 47 phase 3 trials) were available for analysis. A summary by race is provided in the Table, excluding unknown, which represented 8.5% of phase 2 and 3.5% of phase 3 trials. The proportions of white/black patients enrolled to phase 2 and phase 3 trials beginning in 2010-12 were 84.4%/11% and 83.1%/9.9%, respectively (total enrollment 84.9%/9.6%). For trials beginning in 2015-17, white/black enrollment represented 88.5%/8.1% of patients enrolled to phase 2 and 86.4%/10.1% of patients in phase 3 trials. Black patients represented 9.6% of all trial participants, in contrast with the SEER data where 12% of all patients were black (p < 0.001). For lung cancer trials, black participants represented only 7.9% of all trial participants whereas in breast cancer trials, 10.2% of participants were black, versus the SEER data specific to these tumor types (black patients represent 10.9%/11.5% of lung/breast cancer diagnoses between 2013 to 2017, both p < 0.01). Conclusions: This study suggests that over the past decade most races (other than white) have been significantly underrepresented in US oncology clinical trials, and is even more pronounced for black patients with lung cancer. Based on this analysis, there is no evidence that trial enrollment distribution, particularly of white versus black participants, has changed since 2010. Data are limited to the relative lack of studies reporting results that began enrollment after 2017. These findings suggest that the development of new strategies to improve the recruitment of racial minorities to oncology clinical trials are warranted.[Table: see text]

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