Representation of minorities in oncology clinical trials: Review of the past 14 years.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 2533-2533
Author(s):  
Narjust Duma ◽  
Jesus Vera Aguilera ◽  
Jonas Paludo ◽  
Yucai Wang ◽  
Konstantinos Leventakos ◽  
...  
Keyword(s):  
Clinical Trials ◽  
African Americans ◽  
Historical Data ◽  
Molecular Testing ◽  
Chi Square ◽  
Cancer Prevalence ◽  
The Past ◽  
Therapeutic Trials ◽  
Oncology Clinical Trials ◽  
Breast And Prostate Cancer

2533 Background: Many cancer clinical trials (CT) lack appropriate representation of specific patients populations, limiting the generalizability of the evidence obtained. Therefore, we determined the representation of ethnic minorities in oncology CT. Methods: Enrollment data from all therapeutic trials reported as completed in clinicaltrial.gov from 2003 to 2016 were analyzed. CT in rare cancers (< 1% incidence) or with recruitment outside of the US were excluded. Enrollment fraction (EF) was defined as the number of enrollees divided by the 2013 SEER database cancer prevalence. Chi-square test was used to estimate differences in categorical data. Results: Out of 1,012 CT, 310 (31%) reported ethnicity with a total of 55689 enrollees. Distribution by race and comparison with data from 1996-2002, US cancer prevalence and US census are described in the Table. Participation in CT varied significantly across ethnic groups, non-Hispanic Whites (NHW) were more likely to be enrolled in CT (EF of 1.2%) than African Americans (EF of 0.7%, p < 0.001) and Hispanics (EF of 0.4%, p<0.001). A decrease in African Americans (AA) and Hispanics (H) enrollment was observed when compared with historical data from 1996 to 2002. Hispanics were less represented in breast and prostate cancer CT contributing only to 3% and 1.5% of the study population; African Americans were less represented in lung (5.4%) and renal cell carcinoma (3%) trials. Asians were well represented and their recruitment doubled over the past 14 years (2% vs 5.3%). Conclusions: African Americans and Hispanics were less likely to be enrolled in CT. Comparing with historical data; we observed a decrease in minorities’ recruitment in the past 14 years. This change could be attributed to the increased complexity of CT and mandatory molecular testing as many minorities lack access to institutions with genetic testing capacity. Future trials should take extra measures to recruit participants that adequately represent the U.S. cancer population. [Table: see text]

scholarly journals Representation of Minorities and Women in Oncology Clinical Trials: Review of the Past 14 Years

2018 ◽  
Vol 14 (1) ◽  
pp. e1-e10 ◽  
Author(s):  
Narjust Duma ◽  
Jesus Vera Aguilera ◽  
Jonas Paludo ◽  
Candace L. Haddox ◽  
Miguel Gonzalez Velez ◽  
...  
Keyword(s):  
Clinical Trials ◽  
African Americans ◽  
Historical Data ◽  
The Elderly ◽  
Cancer Clinical Trials ◽  
Specific Patient ◽  
The Past ◽  
Therapeutic Trials ◽  
Oncology Clinical Trials ◽  
Enrollment Data

Purpose: Many cancer clinical trials lack appropriate representation of specific patient populations, limiting their generalizability. Therefore, we determined the representation of ethnic minorities and women in cancer clinical trials. Methods: Enrollment data from all therapeutic trials reported as completed in ClinicalTrials.gov from 2003 to 2016 were analyzed. We calculated enrollment fractions (EFs) for each group, defined as the number of enrollees divided by the 2013 Surveillance, Epidemiology, and End Results (SEER) database cancer prevalence. Results: Of 1,012 clinical trials, 310 (31%) reported ethnicity with a total of 55,689 enrollees. Participation varied significantly across ethnic groups. Non-Hispanic whites were more likely to be enrolled in clinical trials (EF, 1.2%) than African Americans (EF, 0.7%; P < .001) and Hispanics (EF, 0.4%; P < .001). A decrease in African American (6% v 9.2%) and Hispanic (2.6% v 3.1%) enrollment was observed when compared with historical data from 1996 to 2002. Younger patients (age younger than 65 years) were more likely to be enrolled in clinical trials than the elderly (64% v 36%; P < .001). Low recruitment of female patients was observed in clinical trials for melanoma (35%), lung cancer (39%), and pancreatic cancer (40%). Conclusion: We observed a decrease in recruitment of minorities over the past 14 years compared with historical data. African Americans, Hispanics, and women were less likely to be enrolled in cancer clinical trials. Future trials should take extra measures to recruit participants that adequately represent the US cancer population.

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.

Reporting of patient reported outcome (PRO) in clinical trials: A systematic review of clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6590-6590 ◽  
Author(s):  
Liat Vidal-Fisher ◽  
Laura Vidal Boixader ◽  
Vasily Andrianov ◽  
Kelly Kevelin Curtis ◽  
Daniel Shepshelovich ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Trials ◽  
Patient Reported Outcome ◽  
Phase 3 ◽  
The Past ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

6590 Background: Clinically relevant outcomes as improvements in overall survival (OS) or quality of life (QOL) should guide decision-making. The FDA encourages the implementation of patient-centric measures in clinical trials. Over the past decade a growing number of protocols have included PROs in their outcome measures. We aimed to evaluate the frequency at which PRO measures, incorporated into clinical trials, are made publicly available, when trial results are published. Methods: We searched Citeline Trialtrove database, a registry of clinical trials, for randomized phase 3 trials of patients with non-small cell lung cancer (NSCLC), recruiting during 2006-2016, with PRO listed. We excluded trials evaluating supportive treatment, and those unpublished. We identified publications associated with the trial, and extracted various parameters, including whether or not PRO outcome was published. Results: Of 158 NSCLC trials identified, 99 listed at least 1 PRO. 24 trials were excluded (supportive care, unpublished). The commonly used scales were EORTC-QLQ C30, QLQ-LC13, LCSS, FACT-L, and EQ-5D. Study sponsor was industry in 45 trials, and industry-academic in 12 trials. Of 75 trials analyzed, 41 (55%) published the results of the PRO endpoint. Only 37% of the 75 included a comprehensive report of PRO, and many publications referenced the PRO briefly. Of 41 trials that reported PRO, only 21 (51%) provided information about missing PRO data. 59 trials were published as full-text, of which 40 (68%) reported the PRO, and 53% reported the PRO more than 6 months after the initial full publication. Of the trials that showed PFS benefit, with no OS benefit, 22/34 (65%) published the results of the PRO endpoints. Conclusions: Despite a growing emphasis on QOL and the inclusion of PROs in oncology clinical trials, and despite patient and healthcare provider efforts to record PRO data, a significant number of NSCLC randomized trials do not report the PRO. The collection of PRO data should result in routine, timely and appropriate reporting as part of the trial outcome publication, to allow for a thorough assessment of investigational clinically relevant treatment effect.

A proposed modification to Hy's law and Edish criteria in oncology clinical trials using aggregated historical data

2013 ◽  
Vol 22 (6) ◽  
pp. 571-578 ◽  
Author(s):  
Daniel Parks ◽  
Xiwu Lin ◽  
Jeffery L. Painter ◽  
Jie Cheng ◽  
Christine M. Hunt ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Historical Data ◽  
Oncology Clinical Trials ◽  
Proposed Modification ◽  
Hy’S Law

scholarly journals Clinical Trials in Chronic Liver Disease - What Do They Achieve?

2004 ◽  
Vol 18 (8) ◽  
pp. 489-492
Author(s):  
Jenny Heathcote
Keyword(s):  
Clinical Trials ◽  
Liver Disease ◽  
Drug Discovery ◽  
Pharmaceutical Industry ◽  
Chronic Liver Disease ◽  
Potential Benefit ◽  
Chronic Liver ◽  
The Past ◽  
Therapeutic Trials ◽  
The Individual

The past 30 years have seen rapid growth in the number of clinical trials in liver disease; due mostly to effective drug discovery programs by the pharmaceutical industry. The advantages associated with therapeutic trials in chronic liver disease, or any other disease for that matter, go far beyond potential benefit to the individual patient, other beneficiaries include the treating physician, the sponsoring agency and their investors, the institution/university and the general public. But there is always a downside to any experiment. The disadvantages and advantages of clinical trials in liver disease are the topics for this discussion.

scholarly journals Novel Method for Benchmarking Recruitment of African American Cancer Patients to Clinical Therapeutic Trials

2008 ◽  
Vol 26 (31) ◽  
pp. 5074-5077 ◽  
Author(s):  
Keith H. Morgenlander ◽  
Sharon B. Winters ◽  
Chyongchiou J. Lin ◽  
Linda B. Robertson ◽  
Dwight E. Heron ◽  
...  
Keyword(s):  
Clinical Trials ◽  
African American ◽  
African Americans ◽  
General Population ◽  
Cancer Patients ◽  
Cancer Incidence ◽  
Age Distribution ◽  
Recruitment Rate ◽  
Invasive Cancer ◽  
Therapeutic Trials

Purpose The National Cancer Institute (NCI) has historically evaluated the participation of underserved minorities within University of Pittsburgh Cancer Institute (UPCI) clinical trials in relation to the proportion of African Americans in the general population of the UPCI primary service area of Allegheny County (12%). This standard seemed to be unrealistically high as a result of a younger age distribution of African Americans within the county. Methods The proportions of African Americans within the following four separate county populations were compared using data from 2000 to 2004: general population; invasive cancer patients; invasive cancer patients diagnosed or treated at UPCI-affiliated facilities; and patients enrolled onto UPCI's clinical therapeutic trials. Results Although the proportion of African Americans within the general population was approximately 13%, only 9.8% of patients diagnosed with invasive cancers were African American. Approximately 9.5% of all cancer patients diagnosed or treated at UPCI facilities were African American, which is comparable to the county-wide percentage of African American cancer patients. Recruitment rate of African Americans to oncology clinical trials from within the UPCI patient population was 7.6%. The NCI benchmark did not reflect the actual invasive cancer incidence rate in African American patients. By comparing the percentage of African Americans contributing to cancer incidence with the percentage of African American cancer patients treated at research-affiliated institutions, a more appropriate benchmark was derived. Conclusion The method developed by UPCI is recommended as a useful mechanism for benchmarking recruitment of African American cancer patients to clinical therapeutic trials at other cancer centers.

scholarly journals Oncology Clinical Trials During the COVID-19 Pandemic

ONCOLOGY ◽  
2020 ◽  
pp. 265-269
Author(s):  
Aline Lara Gongora ◽  
Denis Jardim ◽  
Diogo Assed Bastos
Keyword(s):  
Clinical Trials ◽  
Mortality Rates ◽  
Research Community ◽  
Regulatory Agencies ◽  
Patients With Cancer ◽  
The Past ◽  
Oncology Research ◽  
Oncology Clinical Trials ◽  
National Governments ◽  
To Receive

The coronavirus disease 2019 (COVID-19) pandemic has rapidly spread all over the world in the past several months. No effective treatment for COVID-19 has been established. High transmissibility and considerable mortality rates have forced many national governments to implement quarantine measures. Many patients with cancer rely on clinical trials to receive their oncologic care, but the routine conduct of clinical trials has substantially changed because of the COVID-19 pandemic. The oncology research community should implement formal policies based on the guidance given from regulatory agencies, with the goal of minimizing the risks of COVID-19 infection while maintaining appropriate oncologic treatments for patients during this pandemic.

Methodology, results, and publication of oncology clinical trials: Insights from all the world’s randomized controlled trials (RCTs) 2014-2017.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 2019-2019
Author(s):  
Shubham Sharma ◽  
Connor Wells ◽  
Joey C. Del Paggio ◽  
Wilma M. Hopman ◽  
Bishal Gyawali ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Primary Endpoint ◽  
Clinical Benefit ◽  
High Income ◽  
Study Cohort ◽  
Cancer Therapies ◽  
Chi Square ◽  
Clinical Cancer Research ◽  
Substantial Clinical Benefit ◽  
Oncology Clinical Trials

2019 Background: Clinical cancer research is now a global effort. Most published overviews of oncology trials are restricted to a specific disease site or cohort of high-profile journals. Here we describe authorship, trial characteristics, design, and results of all oncology RCTs published globally during 2014-2017. Methods: A structured literature search was designed using PUBMED to identify all RCTs evaluating anti-cancer therapies published during 2014-2017. Data were captured regarding authorship, participants, study characteristics, design, and results. Among superiority RCTs that met the primary endpoint (i.e. statistically “positive”), we calculated the ESMO-MCBS to identify trials with substantial clinical benefit (MCBS scores 4/5 or A/B). Outcomes were compared with Chi Square or Fisher’s Exact tests. Results: The study cohort included 694 RCTs. The most common cancers evaluated were breast (17%, 121/694), lung (15%, 104/694) and colorectal (8%, 58/694). Treatment intent was curative, adjuvant/neoadjuvant, and palliative in 10% (68/694), 25% (176/694), and 65% (448/694) of trials respectively. Median sample size was 443 (IQR 246-718). Seventy percent (488/694) of RCTs were supported by industry; 87% (601/694) of experimental arms tested systemic therapy. Ninety-two percent (636/694) of RCTs were led by investigators in 28 high-income countries; the most common countries leading these trials were US (27%, 174/636), France (10%, 64/636), Germany (10%, 62/636), Japan (9%, 59/636), and UK (9%, 57/636). The most common primary endpoints were PFS (32%, 220/694), OS (31%, 215/694), and DFS (11%, 79/694); Forty-six percent of all trials (318/694) met their primary endpoint. Among superiority trials with “positive” results, 33% met ESMO-MCBS threshold for substantial clinical benefit. The median impact factor (IF) of journals which published the overall study cohort of trials was 21 (IQR 7-27); trials meeting their primary endpoint were published in higher profile journals (median IF 25 vs 18, p < 0.001). Conclusions: At the global level, oncology clinical trials are dominated by high-income countries and study diseases which do not necessarily reflect the global burden of cancer. The vast majority of trials are funded by industry and only one third of “positive” trials meet ESMO-MCBS threshold for substantial clinical benefit.

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