Financial Relationships Between Industry and Principal Investigators of United States Cooperative Group Randomized Cancer Clinical Trials

2021 ◽  
Author(s):  
April L. Metzger ◽  
Adams Kusi Appiah ◽  
Christopher M. Wright ◽  
Vikram Jairam ◽  
Arya Amini ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
Cooperative Group ◽  
Principal Investigators ◽  
Financial Relationships

Enrollment disparities in cancer clinical trials leading to FDA approvals between 2008 and 2020.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18501-e18501
Author(s):  
Ryan Huu-Tuan Nguyen ◽  
Yomaira Silva ◽  
Vijayakrishna K. Gadi
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Clinical Trials ◽  
Drug Approval ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Cancer Prevalence ◽  
Fda Approval ◽  
The Us ◽  
Enrollment Data

e18501 Background: Cancer clinical trials based in the United States (US) have lacked adequate representation of racial and ethnic minorities, the elderly, and women. Pivotal clinical trials leading to United States Food and Drug Administration (FDA) approval are often multi-national trials and may also lack generalizability to underrepresented populations in the United States. We determined the racial, ethnic, age, and sex enrollment in pivotal trials relative to the US cancer population. Methods: We reviewed the FDA’s Drug Approvals and Databases for novel and new use drug approvals for breast, colorectal, lung, and prostate cancer indications from 2008 through 2020. Drugs@FDA was searched for drug approval summaries and FDA labels to identify clinical trials used to justify clinical efficacy that led to FDA approval. For eligible trials, enrollment data were obtained from FDA approval summaries, FDA labels, ClinicalTrials.gov, and corresponding journal manuscripts. Enrollment Fraction (EF) was calculated as enrollment in identified clinical trials divided by 2017 SEER cancer prevalence. All data sources were publicly available. Results: From 2008 through 2020, 60 drugs received novel or new use drug approval for breast, colorectal, lung, or prostate cancer indications based on 66 clinical trials with a total enrollment of 36,830. North America accounted for 9,259 (31%) enrollees of the 73% of trials reporting location of enrollment. Racial demographics were reported in 78% of manuscripts, 66% of ClinicalTrials.gov pages, and 98% of FDA labels or approval summaries. Compared with a 0.4% enrollment fraction among White patients, lower enrollment fractions were noted in Hispanic (0.2%, odds ratio [OR] vs White, 0.46; 95% confidence interval [CI], 0.43 to 0.49, P< 0.001) and Black (0.1%, OR 0.29; 95% CI 0.28 to 0.31, P< 0.001) patients. Elderly patients (age ≥ 65 years) were less likely than younger patients to be enrollees (EF 0.3% vs 0.9%, OR 0.27; 95% CI 0.26 to 0.27, P< 0.001) despite accounting for 61.3% of cancer prevalence. For colorectal and lung cancer trials, females were less likely than males (EF 0.7% vs 1.1%, OR 0.66; 95% CI 0.63 to 0.68, P< 0.001) to be enrolled. Conclusions: Black, Hispanic, elderly, and female patients were less likely to enroll in cancer clinical trials leading to FDA approvals from 2008 to 2020. Race and geographic enrollment data were inconsistently reported in journal manuscripts and ClinicalTrials.gov. The lack of appropriate representation of specific patient populations in these key clinical trials limits their generalizability. Future efforts must be made to ensure equitable access, representation, and reporting of enrollees that adequately represent the US population of patients with cancer.

scholarly journals Cooperative Group Cancer Clinical Trials: An NCIC Clinical Trials Group

2011 ◽  
Vol 5 (6) ◽  
pp. 379-381
Author(s):  
Ralph M. Meyer ◽  
Heather A. Stanton ◽  
Wendy R. Parulekar ◽  
Fred Saad
Keyword(s):  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
Cooperative Group

Clinical trial metrics: Protocol performance and resource utilization from 14 cancer centers

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6557-6557 ◽  
Author(s):  
H. J. Durivage ◽  
K. D. Bridges
Keyword(s):  
Adverse Effect ◽  
Clinical Trials ◽  
Resource Utilization ◽  
Cancer Clinical Trials ◽  
Guidance Document ◽  
Cooperative Group ◽  
Cancer Centers ◽  
Start Up ◽  
Protocol Performance ◽  
Selection Of

6557 Background: Observations at the authors’ institutions and by Dilts et al (JCO 2008, abstr 6534) indicate a high percentage of industry (IND)- and cooperative group (CG)-sponsored therapeutic clinical trials (TCTs) with minimal enrollment. We observed most of the enrollment from a small proportion of the TCTs. To determine if this data was representative of other cancer centers (CCs) we examined accrual to IND- and CG-sponsored adult TCTs from 14 CCs. Methods: Accrual data to IND- and CG-sponsored TCTs was obtained from 14 U.S. CCs. Data for the 3-year period from 2005 through 2007 was analyzed. Pediatric TCTs were excluded. Results: Of 2,685 TCTs, 1455 (54.2%) did not accrue any patients (pts). Only 713 (26.6%) TCTs enrolled > 2 pts and these TCTs provided 88.8% of the total enrollment. Resource utilization: We estimate > 230,000 hours (median: 3,773 hours per CC per year) were devoted to study start up and regulatory maintenance for the 1,455 TCTs that did not accrue any pts (Guidance Document for Implementing Effective Cancer Clinical Trials, www.c-changetogether.org/pubs/default.asp). Conclusions: Approximately 90% of the accrual to IND and CG TCTs is from 26% of these TCTs. Significant resources are used on TCTs that do not contribute significantly to overall accrual. Effective rules governing selection of IND and CG TCTs for activation are needed. Effective rules will enable centers to re-direct valuable resources to useful activities without adverse effect on overall enrollment. [Table: see text] No significant financial relationships to disclose.

Value of information analyses for real-time prioritization decisions within a cancer clinical trials cooperative group.

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. 6506-6506
Author(s):  
Caroline Savage Bennette ◽  
Scott David Ramsey ◽  
David Leroy Veenstra ◽  
Anirban Basu ◽  
Josh John Carlson
Keyword(s):  
Clinical Trials ◽  
Real Time ◽  
Value Of Information ◽  
Cancer Clinical Trials ◽  
Cooperative Group

scholarly journals Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

2007 ◽  
Vol 25 (32) ◽  
pp. 5051-5057 ◽  
Author(s):  
Deborah Watkins Bruner ◽  
Charlene J. Bryan ◽  
Neil Aaronson ◽  
C. Craig Blackmore ◽  
Michael Brundage ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Online Survey ◽  
Cancer Control ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Cooperative Group ◽  
Cooperative Groups ◽  
End Points ◽  
Patient Reported

Purpose The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. Methods An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. Results There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. Conclusion The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need to be addressed.

Increasing Minority Participation in Cancer Clinical Trials: The Minority-Based Community Clinical Oncology Program Experience

2005 ◽  
Vol 23 (22) ◽  
pp. 5247-5254 ◽  
Author(s):  
Worta McCaskill-Stevens ◽  
Martha M. McKinney ◽  
Cynthia G. Whitman ◽  
Lori M. Minasian
Keyword(s):  
Clinical Trials ◽  
Temporal Trends ◽  
Cancer Clinical Trials ◽  
Cooperative Group ◽  
Factors Affecting ◽  
Treatment Trials ◽  
Minority Participation ◽  
Minority Enrollment ◽  
Community Clinical Oncology Program ◽  
Major Factors

Purpose The National Cancer Institute's (NCI) Minority-Based Community Clinical Oncology Program (MBCCOP) seeks to enhance minority participation in cancer clinical trials by building clinical trials outreach and management capacity in healthcare institutions serving large numbers of minority cancer patients. This article examines temporal trends in MBCCOP accruals to cancer prevention and control (CP/C) and cancer treatment trials and the racial distribution of study participants, along with the major factors affecting minority enrollment. Methods We used NCI databases to analyze temporal trends in overall accruals and accruals by race. We analyzed transcripts from an NCI-sponsored meeting with MBCCOP principal investigators and data from a follow-up survey to identify factors affecting minority enrollment. Results Between 1992 and 2003, annual patient accruals to treatment trials increased 39% despite little change in the number of MBCCOP grantees. During this same period, annual participant accruals to CP/C trials more than doubled. Between 1995 and 2003, minorities comprised 51% to 67% of the MBCCOP patients accrued to cooperative group treatment trials compared with ≤ 23% of the patients accrued by other cooperative group members and affiliates. Major factors affecting minority enrollment include the availability of “clinically relevant” protocols, regulatory requirements, characteristics of the patient population, and the level of support from sponsoring institutions and community physicians. Conclusion MBCCOPs have demonstrated their ability to facilitate the participation of racial/ethnic minorities in clinical trials. However, the contributions that they could make to the design and conduct of minority-focused research studies merit further exploration.

Summary of the proceedings of the United States-Japan lung cancer clinical trials summit

1997 ◽  
Vol 123 (8) ◽  
pp. 461-466
Author(s):  
Robert B. Livingston ◽  
Ryosuke Tsuchiya ◽  
Masanori Fukushima ◽  
Charles A. Coltman Jr.
Keyword(s):  
United States ◽  
Lung Cancer ◽  
Clinical Trials ◽  
The United States ◽  
Cancer Clinical Trials

Clinical Cancer Advances 2010: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology

2010 ◽  
Vol 28 (36) ◽  
pp. 5327-5347 ◽  
Author(s):  
Mark G. Kris ◽  
Steven I. Benowitz ◽  
Sylvia Adams ◽  
Lisa Diller ◽  
Patricia Ganz ◽  
...  
Keyword(s):  
United States ◽  
Cancer Research ◽  
Clinical Trials ◽  
Clinical Oncology ◽  
The United States ◽  
Cooperative Group ◽  
Institute Of Medicine ◽  
Group Program ◽  
American Society ◽  
The Right

A MESSAGE FROM ASCO'S PRESIDENT Like many health professionals who care for people with cancer, I entered the field because of specific patients who touched my heart. They still do. In an effort to weave together my personal view of what the American Society of Clinical Oncology (ASCO) stands for and the purpose the organization serves, my presidential theme this year is “Patients. Pathways. Progress.” Patients come first. Caring for patients is the most important, rewarding aspect of being an oncology professional. At its best, the relationship between doctor and patient is compassionate and honest—and a relationship of mutual respect. Many professional organizations have an interest in cancer, but no other society is so focused on the entire spectrum of cancer care, education, and research. Nor is any other society as particularly interested in bringing new treatments to our patients through clinical trials as ASCO is. Clinical trials are the crux for improving treatments for people with cancer and are critical for continued progress against the disease. “Pathways” has several meanings. Some pathways are molecular—like the cancer cell's machinery of destruction, which we have only begun to understand in recent years. But there are other equally important pathways, including the pathways new therapies follow as they move from bench to bedside and the pathways patients follow during the course of their diseases. Improved understanding of these pathways will lead to new approaches in cancer care, allowing doctors to provide targeted therapies that deliver improved, personalized treatment. The best pathway for patients to gain access to new therapies is through clinical trials. Trials conducted by the National Cancer Institute's Cooperative Group Program, a nationwide network of cancer centers and physicians, represent the United States' most important pathway for accelerating progress against cancer. This year, the Institute of Medicine released a report on major challenges facing the Cooperative Group Program. Chief among them is the fact that funding for the program has been nearly flat since 2002. ASCO has called for a doubling of funding for cooperative group research within five years and supports the full implementation of the Institute of Medicine recommendations to revitalize the program. ASCO harnesses the expertise and resources of its 28,000 members to bring all of these pathways together for the greater good of patients. Progress against cancer is being made every day—measurable both in our improved understanding of the disease and in our ability to treat it. A report issued in December 2009 by the National Cancer Institute, the Centers for Disease Control and Prevention, the American Cancer Society, and the North American Association of Central Cancer Registries found that rates of new diagnoses and rates of death resulting from all cancers combined have declined significantly in recent years for men and women overall and for most racial and ethnic populations in the United States. The pace of progress can be and needs to be hastened. Much remains to be done. Sustained national investment in cancer research is needed to bring better, more effective, less toxic treatments to people living with cancer. Pathways to progress continue in the clinic as doctors strive to find the right treatments for the right patients, to understand what represents the right treatments, and to partner with patients and caregivers for access to those treatments. This report demonstrates that significant progress is being made on the front lines of clinical cancer research. But although our nation's investment in this research is paying off, we must never forget the magnitude of what lies ahead. Cancer remains the number two killer of Americans. Future progress depends on continued commitment, from both ASCO and the larger medical community. George W. Sledge Jr, MD President American Society of Clinical Oncology

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