Early Detection of Toxicity and Adjustment of Ongoing Clinical Trials: The History and Performance of the North Central Cancer Treatment Group’s Real-Time Toxicity Monitoring Program

2002 ◽  
Vol 20 (23) ◽  
pp. 4591-4596 ◽  
Author(s):  
Richard M. Goldberg ◽  
Daniel J. Sargent ◽  
Roscoe F. Morton ◽  
Michelle R. Mahoney ◽  
James E. Krook ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Cancer Treatment ◽  
Real Time ◽  
Monitoring Program ◽  
The United States ◽  
Phase Iii ◽  
North Central ◽  
Chemotherapy Drugs ◽  
The North

ABSTRACT: Prospective clinical trials are the gold standard for evidence-based methodology used to support changes in the practice of medicine. Clinical researchers, regulatory agencies, payers, and the public embrace the conduct of phase I, II, and III clinical trials as integral to improving patient care. The National Cancer Institute (NCI) funds a number of cooperative oncology groups to conduct such clinical trials in the United States. In order to protect enrolling patients, the NCI requires expedited reporting to allow rapid identification of severe side effects on NCI-sponsored clinical trials. However, chemotherapy drugs frequently cause predictable side effects, the rapid reporting of which would potentially overwhelm the system. This article describes the development and documents the performance of a real-time toxicity reporting system implemented by the North Central Cancer Treatment Group. The goal of this system is to supplement the currently required NCI adverse event monitoring procedures and to permit study teams to identify the need to modify ongoing clinical trials. The system has proven its value in the monitoring of phase II and III trials, including trial N9741, a three-arm, phase III, advanced colorectal cancer chemotherapy study exploring combinations of irinotecan, oxaliplatin, and fluorouracil. We believe the methods described present opportunities for improving patient safety in clinical research.

scholarly journals Evaluation of the Value of Attribution in the Interpretation of Adverse Event Data: A North Central Cancer Treatment Group and American College of Surgeons Oncology Group Investigation

2010 ◽  
Vol 28 (18) ◽  
pp. 3002-3007 ◽  
Author(s):  
Shauna L. Hillman ◽  
Sumithra J. Mandrekar ◽  
Brian Bot ◽  
Ronald P. DeMatteo ◽  
Edith A. Perez ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Treatment Group ◽  
Cancer Treatment ◽  
Randomized Clinical Trials ◽  
Study Drug ◽  
Phase Iii ◽  
Oncology Group ◽  
North Central ◽  
American College Of Surgeons ◽  
Group Trial

Purpose In March 1998, Common Toxicity Criteria (CTC) version 2.0 introduced the collection of attribution of adverse events (AEs) to study drug. We investigate whether attribution adds value to the interpretation of AE data. Patients and Methods Patients in the placebo arm of two phase III trials—North Central Cancer Treatment Group Trial 97-24-51 (carboxyamino-triazole v placebo in advanced non–small-cell lung cancer) and American College of Surgeons Oncology Group Trial Z9001 (imatinib mesylate v placebo after resection of primary gastrointestinal stromal tumors)—were studied. Attribution was categorized as unrelated (not related or unlikely) and related (possible, probable, or definite). Results In total, 398 patients (84 from Trial 97-24-51 and 314 from Trial Z9001) and 7,736 AEs were included; 47% and 50% of the placebo-arm AEs, respectively, were reported as related. When the same AE was reported in the same patient on multiple visits, the attribution category changed at least once 36% and 31% of the time. AE type and sex (Trial Z9001) and AE type and performance status (Trial 97-24-51) were associated with a higher likelihood of AEs being deemed related. Conclusion Nearly 50% of AEs were reported as attributed to study drug on the placebo arm of two randomized clinical trials. These data provide strong evidence that AE attribution is difficult to determine, unreliable, and of questionable value in interpreting AE data in randomized clinical trials.

Measuring the Incremental Cost of Clinical Cancer Research

2001 ◽  
Vol 19 (1) ◽  
pp. 105-110 ◽  
Author(s):  
Dana P. Goldman ◽  
Michael L. Schoenbaum ◽  
Arnold L. Potosky ◽  
Jane C. Weeks ◽  
Sandra H. Berry ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Treatment ◽  
Incremental Cost ◽  
Cancer Patients ◽  
Phase Ii ◽  
The United States ◽  
Phase Iii ◽  
Ongoing Effort ◽  
Cancer Trials ◽  
The Cost

PURPOSE: To summarize evidence on the costs of treating patients in clinical trials and to describe the Cost of Cancer Treatment Study, an ongoing effort to produce generalizable estimates of the incremental costs of government-sponsored cancer trials. METHODS: A retrospective study of costs will be conducted with 1,500 cancer patients recruited from a randomly selected sample of institutions in the United States. Patients accrued to either phase II or phase III National Cancer Institute–sponsored clinical trials during a 15-month period will be asked to participate in a study of their health care utilization (n = 750). Costs will be measured approximately 1 year after their trial enrollment from a combination of billing records, medical records, and an in-person survey questionnaire. Similar data will be collected for a comparable group of cancer patients not in trials (n = 750) to provide an estimate of the incremental cost. RESULTS: Evidence suggests insurers limit access to trials because of cost concerns. Public and private efforts are underway to change these policies, but their permanent status is unclear. Previous studies found that treatment costs in clinical trials are similar to costs of standard therapy. However, it is difficult to generalize from these studies because of the unique practice settings, insufficient sample sizes, and the exclusion of potentially important costs. CONCLUSION: Denials of coverage for treatment in a clinical trial limit patient access to trials and could impede clinical research. Preliminary estimates suggest changes to these policies would not be expensive, but these results are not generalizable. The Cost of Cancer Treatment Study is an ongoing effort to provide generalizable estimates of the incremental treatment cost of phase II and phase III cancer trials. The results should be of great interest to insurers and the research community as they consider permanent ways to finance cancer trials.

Dealing With a Deluge of Data: An Assessment of Adverse Event Data on North Central Cancer Treatment Group Trials

2005 ◽  
Vol 23 (36) ◽  
pp. 9275-9281 ◽  
Author(s):  
Michelle R. Mahoney ◽  
Daniel J. Sargent ◽  
Michael J. O'Connell ◽  
Richard M. Goldberg ◽  
Paul Schaefer ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Patient Safety ◽  
Treatment Group ◽  
Cancer Treatment ◽  
Phase Iii ◽  
Small Subset ◽  
North Central ◽  
Normal Limits ◽  
Life Threatening

Purpose Adverse events (AEs) are monitored in clinical trials for patient safety, to satisfy reporting requirements, and develop safety profiles. Recently, much attention has been placed on the reporting of serious AEs (SAEs) that are either life threatening or lethal in clinical trials. However, SAEs comprise a small subset of all AE data collected for trials; the majority of AE data collected are routine AEs (RAEs) regarding non–life-threatening events. We assessed the utility of the RAE data collected, relative to the volume. Patients and Methods We surveyed the RAE data from 26 North Central Cancer Treatment Group coordinated trials. Results A total of 8,318 (11%) of 75,598 of RAEs required queries. Of these, 86% were protocol-required RAEs, 83% of RAEs required per protocol were within normal limits (eg, platelets) or not present, and 61% of extra AEs were mild. One fifth of RAEs were considered unlikely to be related or unrelated to treatment. Overall, 3% of events were severe, life threatening, or caused death. Only 1% of RAE data reported required expedited reporting (eg, via Adverse Event Expedited Reporting System). Results indicate that 72% of RAEs would be eliminated if only the maximum severity per patient and type were required. These results were validated in a large phase III trial. Conclusion The majority of RAEs identified, transcribed, and entered are not clinically important. Our data suggest that reducing the number of AEs monitored will affect substantially neither overall patient safety nor compromise evaluation of regimens undergoing testing. We present several considerations for such a reduction in data collection, as well as a policy that we have used to address the deluge of RAE data.

Within-field Pathogenic Diversity of Phytophthora sojae in Commercial Soybean Fields in Iowa

2009 ◽  
Vol 10 (1) ◽  
pp. 8 ◽  
Author(s):  
Alison E. Robertson ◽  
Silvia R. Cianzio ◽  
Sarah M. Cerra ◽  
Richard O. Pope
Keyword(s):  
The United States ◽  
Phytophthora Sojae ◽  
Soil Samples ◽  
Soybean Plant ◽  
North Central Region ◽  
North Central ◽  
The North ◽  
History Of ◽  
The Many ◽  
Pathogenic Diversity

Phytophthora root and stem rot (PRR), caused by the oomycete Phytophthora sojae, is an economically important soybean disease in the north central region of the United States, including Iowa. Previous surveys of the pathogenic diversity of P. sojae in Iowa did not investigate whether multiple pathotypes of the pathogen existed in individual fields. Considering the many pathotypes of P. sojae that have been reported in Iowa, we hypothesized multiple pathotypes could exist within single fields. In the research reported herein, several soil samples were collected systematically from each of two commercial fields with a history of PRR in Iowa, and each soil sample was baited separately for isolates of P. sojae. Numerous pathotypes of P. sojae were detected from both fields. As many as four pathotypes were detected in some soil samples (each consisting of six to eight soil cores), which suggests that a single soybean plant could be subjected to infection by more than one pathotype. This possibility presents important implications in breeding resistant cultivars and in the management of PRR. Accepted for publication 14 July 2009. Published 8 September 2009.

Document Delivery

2011 ◽  
pp. 734-735
Author(s):  
Robin L. Ewing
Keyword(s):  
Distance Education ◽  
The United States ◽  
North Central Association ◽  
Education Students ◽  
Regional Accreditation ◽  
North Central ◽  
Document Delivery ◽  
The North ◽  
Library Resources ◽  
Delivery Services

Document delivery is a service offered by academic libraries that allows distance education students to access or obtain the research materials required for their studies. These services find the document and send a copy of it to the student (Calvert, 2001). Document delivery services aim to provide the same level of service to on-campus students and to off-campus students. They provide access to library materials at the student’s home institution as well as from other libraries. Document delivery services for distance students are generally part of a library’s Interlibrary Loan Department but document delivery can be a separate department. Some libraries have a division or department dedicated to serving distance students and document delivery is handled there when they exist. In the United States, regional accreditation agencies consider document delivery services to be a vital part of a distance education program. For example, the North Central Association of Colleges and Schools’ Guidelines for Distance Education emphasize that students should have access to the appropriate library resources for the field of study (2000).

scholarly journals Performance of Landscape Roses Grown with Minimal Input in the North-central, Central, and South-central United States

2017 ◽  
Vol 27 (5) ◽  
pp. 718-730 ◽  
Author(s):  
David C. Zlesak ◽  
Randy Nelson ◽  
Derald Harp ◽  
Barbara Villarreal ◽  
Nick Howell ◽  
...  
Keyword(s):  
United States ◽  
National Level ◽  
The United States ◽  
The South ◽  
Flower Number ◽  
North Central ◽  
The North ◽  
South Central ◽  
Central United States ◽  
Plant Hardiness

Landscape roses (Rosa sp.) are popular flowering shrubs. Consumers are less willing or able to maintain landscape beds than in years past and require plants that are not only attractive, but well-adapted to regional climatic conditions, soil types, and disease and pest pressures. Marketing and distribution of rose cultivars occurs on a national level; therefore, it is difficult for U.S. consumers in the U.S. Department of Agriculture (USDA) Plant Hardiness Zones 3 to 5 to identify well-adapted, cold-hardy cultivars. Identifying suitable cultivars that have strong genetic resistance to pests and disease and that will tolerate temperature extremes without winter protection in the USDA Plant Hardiness Zones 3 to 5 is of tremendous value to consumers and retailers in northern states. Twenty landscape rose cultivars, primarily developed in north-central North America, were evaluated at five locations in the United States (three in the north-central United States, one in the central United States, and one in the south-central United States) using the low-input, multiyear Earth-Kind® methodology. Six roses had ≥75% plant survival at the end of the study and were in the top 50% of performers for overall mean horticultural rating at each of the three north-central U.S. sites: ‘Lena’, ‘Frontenac’, ‘Ole’, ‘Polar Joy’, ‘Sunrise Sunset’, and ‘Sven’. Five of these six roses met the same criteria at the central United States (exception ‘Lena’) and the south-central United States (exception ‘Polar Joy’) sites. Cultivar, rating time, and their interaction were highly significant, and block effects were not significant for horticultural rating for all single-site analyses of variance. Significant positive correlations were found between sites for flower number, flower diameter, and overall horticultural rating. Significant negative correlations were found between flower number and diameter within each site and also between black spot (Diplocarpon rosae) lesion size from a previous study and overall horticultural rating for three of the five sites. Cane survival ratings were not significantly correlated with overall horticultural rating, suggesting some cultivars can experience severe winter cane dieback, yet recover and perform well. Data from this study benefit multiple stakeholders, including nurseries, landscapers, and consumers, with evidence-based regional cultivar recommendations and breeders desiring to identify regionally adapted parents.

scholarly journals Characteristics of Xanthomonas cucurbitae Isolates from Pumpkins and Survival of the Bacterium in Pumpkin Seeds

Plant Disease ◽  
2018 ◽  
Vol 102 (9) ◽  
pp. 1779-1784 ◽  
Author(s):  
X. Zhang ◽  
M. Babadoost
Keyword(s):  
The United States ◽  
Culture Collection ◽  
Colony Development ◽  
North Central Region ◽  
North Central ◽  
The North ◽  
Significant Difference ◽  
Optimum Ph ◽  
Pumpkin Seeds ◽  
Maximum Temperatures

This study was conducted to determine characteristics of Xanthomonas cucurbitae, the causal agent of bacterial spot of pumpkin, and survival of the bacterium in pumpkin seeds. Fourteen X. cucurbitae isolates from the north central region of the United States, along with the X. cucurbitae strain 23378 from the American Type Culture Collection, were included in this study. The range of minimum, optimum, and maximum temperatures for colony development of X. cucurbitae were 4 to 6°C, 24 to 30°C, and 34 to 36°C, respectively. Optimum pH for colony development ranged from 6.5 to 8.0. Leaves of 3-week-old pumpkins ‘Howden’ and ‘Dickinson’ were inoculated with X. cucurbitae isolates (108 CFU/ml). There was a significant difference in the postinoculation periods for appearance of bacterial lesions on the leaves among the isolates; however, there was no significant difference in diameters of the lesions on each of the pumpkin cultivar 7 days after inoculation. Four of the isolates caused significantly larger lesions on ‘Dickinson’ leaves than ‘Howden’ leaves. Naturally infected ‘Howden’ pumpkin and inoculated ‘Dickinson’ pumpkin seeds with X. cucurbitae were stored at 4 and 22°C. X. cucurbitae was isolated from both naturally infected and inoculated seeds 24 months after storage at both 4 and 22°C, and the isolated bacteria were pathogenic.

Sign in / Sign up

Export Citation Format

Share Document