Addiction treatment trials: how gender, race/ethnicity, and age relate to ongoing participation and retention in clinical trials

Purpose A prior analysis by the Southwest Oncology Group (SWOG) showed that women and African American patients were adequately represented on cancer clinical treatment trials but that older patients were substantially underrepresented. Twenty-five percent of patients ≥ 65 years old were enrolled onto SWOG trials from 1993 to 1996, whereas 63% of all patients with cancer were ≥ 65 years old. Recognition of this under-representation led to a change in Medicare policy in 2000 to include coverage of routine patient care costs of clinical trials. We conducted an updated analysis of accrual trends. Methods The proportions of enrollment onto SWOG treatment trials by sex, race/ethnicity, and age (≥ 65 years) were computed for the years 1997 to 2000; corresponding rates in the United States were derived from US Census and National Cancer Institute Surveillance, Epidemiology, and End Results data. Additionally, method of payment data were analyzed over time (1993 to 2003) to assess whether patterns in method of payment changed with the new Year 2000 Medicare policy on clinical trials coverage. Results The results showed continued adequate representation by sex and race/ethnicity. Older patient accrual on SWOG trials increased significantly since 2000, with 31% of patients ≥ 65 years old enrolled from 1997 to 2000 and 38% enrolled from 2001 to 2003 (v 25% from 1993 to 1996). The percentage of patients using Medicare plus supplemental insurance also increased beginning in 2000, whereas the percentage of patients using Medicare alone remained the same. Conclusion Method of payment analyses provided evidence that the Year 2000 Medicare policy change had a positive impact, but only for those patients with supplemental private coverage of coinsurance costs. Improvements in the Medicare payment structure could further increase older patient participation in clinical trials.

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EPID-07. ACCESS TO GLIOBLASTOMA CLINICAL TRIALS FOR RURAL PATIENTS IN THE UNITED STATES FROM 2010–2020

Neuro-Oncology ◽

10.1093/neuonc/noaa215.325 ◽

2020 ◽

Vol 22 (Supplement_2) ◽

pp. ii79-ii79

Author(s):

Kathryn Nevel ◽

Samuel Capouch ◽

Lisa Arnold ◽

Katherine Peters ◽

Nimish Mohile ◽

...

Keyword(s):

United States ◽

Clinical Trials ◽

Rural Communities ◽

The United States ◽

Interventional Treatment ◽

Phase Ii Trials ◽

Treatment Trials ◽

Rural Sites ◽

Rural Patients ◽

Urban Sites

Abstract BACKGROUND Patients in rural communities have less access to optimal cancer care and clinical trials. For GBM, access to experimental therapies, and consideration of a clinical trial is embedded in national guidelines. Still, the availability of clinical trials to rural communities, representing 20% of the US population, has not been described. METHODS We queried ClinicalTrials.gov for glioblastoma interventional treatment trials opened between 1/2010 and 1/2020 in the United States. We created a Structured Query Language database and leveraged Google application programming interfaces (API) Places to find name and street addresses for the sites, and Google’s Geocode API to determine the county location. Counties were classified by US Department of Agriculture Rural-Urban Continuum Codes (RUCC 1–3 = urban and RUCC 4–9 = rural). We used z-ratios for rural-urban statistical comparisons. RESULTS We identified 406 interventional treatment trials for GBM at 1491 unique sites. 8.7% of unique sites were in rural settings. Rural sites opened an average of 1.7 trials/site and urban sites 2.8 trials/site from 1/2010–1/2020. Rural sites offered more phase II trials (63% vs 57%, p= 0.03) and fewer phase I trials (22% vs 28%, p= 0.01) than urban sites. Rural locations were more likely to offer federally-sponsored trials (p< 0.002). There were no investigator-initiated or single-institution trials offered at rural locations, and only 1% of industry trials were offered rurally. DISCUSSION Clinical trials for GBM were rarely open in rural areas, and were more dependent on federal funding. Clinical trials are likely difficult to access for rural patients, and this has important implications for the generalizability of research as well as how we engage the field of neuro-oncology and patient advocacy groups in improving patient access to trials. Increasing the number of clinical trials in rural locations may enable more rural patients to access and enroll in GBM studies.

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Reporting race/ethnicity in epilepsy clinical trials

Epilepsy & Behavior ◽

10.1016/j.yebeh.2004.05.010 ◽

2004 ◽

Vol 5 (5) ◽

pp. 743-745 ◽

Cited By ~ 12

Author(s):

Jorge G. Burneo ◽

Roy Martin

Keyword(s):

Clinical Trials ◽

Race Ethnicity

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Abstract TP409: Reporting of Key Demographic Characteristics in Neurological Trials Registered on ClinicalTrials.gov

Stroke ◽

10.1161/str.48.suppl_1.tp409 ◽

2017 ◽

Vol 48 (suppl_1) ◽

Author(s):

Kush Fansiwala ◽

Lauren Southwick ◽

Emily Goldmann ◽

Nina S Parikh ◽

Joy Madubuonwu ◽

...

Keyword(s):

Clinical Trials ◽

Race And Ethnicity ◽

Neurological Diseases ◽

Demographic Characteristics ◽

Mandatory Reporting ◽

Trial Participation ◽

Limited Participation ◽

Chi Square ◽

Before And After ◽

Race Ethnicity

Introduction: To increase the transparency of clinical trial information, U.S. Congress passed the Food and Drug Administration (FDA) Amendments Act of 2007, which expanded prior legislation to mandate inclusion of specific trial characteristics, such as funding source and gender demographics, in a new basic results section on ClinicalTrials.gov. Few studies have examined the extent to which key demographic characteristics such as sex and race/ethnicity are reported for neurological trials on ClinicalTrials.gov. Methods: As part of the National Initiative for Minority Involvement in Neurological Clinical Trials (NIMICT), we systematically identified neurological clinical trials on ClinicalTrials.gov (for stroke, epilepsy, Alzheimer’s Disease [AD]) and examined the proportion that reported sex, race, and ethnicity (Hispanic/Latino or not) of study participants. We used the website’s advanced search feature to evaluate demographic information reported from trials conducted between 1999 and 2015. We first calculated frequencies of trials reporting these characteristics, then assessed differences in reporting of each characteristic (yes/no) by condition (stroke, epilepsy, AD) and between trials conducted before and after the basic results section update (pre- and post-2008) using chi-square tests. Results: Our sample comprised 251,847 subjects across 393 trials (147 stroke, 127 epilepsy, 115 AD). Overall, sex was reported for nearly all trials (99.0%), while reporting of race and ethnicity was low (ethnicity: 14.0%, race: 19.8%). Reporting of these characteristics did not differ significantly across the three conditions or between periods preceding and following the FDA act. Conclusion: While ClinicalTrials.gov mandates reporting of sex, it does not require reporting of race/ethnicity, and few trials report these characteristics. This lack of information prevents understanding of neurological trial participation and how interventions might impact patients differently by race/ethnicity. Mandatory reporting of race/ethnicity would enhance transparency and increase awareness of the limited participation of racial/ethnic minorities-who suffer disproportionately from neurological diseases-in neurological trials.

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Race/Ethnicity and the Pharmacogenetics of Reported Suicidality With Efavirenz Among Clinical Trials Participants

The Journal of Infectious Diseases ◽

10.1093/infdis/jix248 ◽

2017 ◽

Vol 216 (5) ◽

pp. 554-564 ◽

Cited By ~ 15

Author(s):

Katie R Mollan ◽

Camlin Tierney ◽

Jacklyn N Hellwege ◽

Joseph J Eron ◽

Michael G Hudgens ◽

...

Keyword(s):

Clinical Trials ◽

Race Ethnicity

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Race and ethnicity representation in clinical trials: findings from a literature review of Phase I oncology trials

Future Oncology ◽

10.2217/fon-2020-1262 ◽

2021 ◽

Author(s):

D Ross Camidge ◽

Haeseong Park ◽

Karen E Smoyer ◽

Ira Jacobs ◽

Lauren J Lee ◽

...

Keyword(s):

Clinical Trials ◽

Phase I ◽

Predominantly White ◽

Race And Ethnicity ◽

Phase I Trials ◽

Minimal Representation ◽

Phase I Clinical Trials ◽

Demographic Representation ◽

The Usa ◽

Race Ethnicity

Aim: To provide an assessment of published literature on the demographic representation in Phase I trials of biopharmaceutical oncology agents. Materials & methods: We conducted a rapid evidence assessment to identify demographic representation reported in Phase I clinical trials for biopharmaceutical oncology agents published in 2019. Results: Globally, the population was predominantly White/Caucasian (62.2%). In the USA, the distribution was heavily skewed toward White/Caucasian (84.2%), with minimal representation of Blacks/African–Americans (7.3%), Asians (3.4%), Hispanics/Latinos (2.8%) or other race/ethnicity groups. Conclusion: Our data highlight that Phase I oncology trials do not reflect the population at large, which may perpetuate health disparities. Further research is needed to understand and address barriers to participation, particularly among under-represented groups

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Racial disparities in access to prostate cancer clinical trials: A county-level analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.6553 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 6553-6553

Author(s):

Aasthaa Bansal ◽

Wei-Jhih Wang ◽

Caroline Savage Bennette ◽

Scott David Ramsey

Keyword(s):

Prostate Cancer ◽

Clinical Trials ◽

Cancer Treatment ◽

Cancer Clinical Trials ◽

County Level ◽

Prostate Cancer Treatment ◽

Cancer Trial ◽

Treatment Trials ◽

Per Capita ◽

The Relationship

6553 Background: African American men (AAs) have a higher burden of prostate cancer compared to other populations. We sought to determine if they experience disparities in access to prostate cancer clinical trials. Methods: We created a county-level database of all U.S. counties by linking together prostate cancer clinical trial data from the Aggregate Analysis of ClincalTrials.gov (AACT) database with county-level socioeconomic, demographic and healthcare facility data derived from several external data sources. Using this data linkage, we examined two specific potential access barriers. First, we investigated the relationship between %AAs in the county and access to NCI designated cancer facilities, adjusting for county population size and other characteristics. Then, among counties with cancer facilities, we investigated the relationship between the %AAs in the county and number of available prostate cancer treatment trials per capita per year. We used logistic and negative binomial regression models, respectively, to address these questions. Results: Between 2008 and 2015, 613 prostate cancer trial sites were found among 3,145 U.S. counties. Counties with higher %AAs were less likely to have cancer facilities (adjusted odds ratio = 0.85, 95% CI (0.78, 0.92)). Among counties with cancer facilities, those with higher %AAs had significantly fewer prostate cancer trials per capita per year (rate ratio per 10% increase in %AAs: 0.90, 95% CI (0.83,0.96)), after adjusting for county-level sociodemographic and healthcare system factors. Conclusions: Counties with higher proportions of AAs appear to be less likely to have access to NCI designated cancer facilities. Among counties with cancer facilities, those with higher proportions of AAs appear to have fewer available prostate cancer treatment trials per capita per year. Clinical trials in prostate cancer therapy should ensure adequate availability of enrollment sites in regions with high concentrations of AAs.

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Long-term outcomes from the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study

Drug and Alcohol Dependence ◽

10.1016/j.drugalcdep.2015.02.030 ◽

2015 ◽

Vol 150 ◽

pp. 112-119 ◽

Cited By ~ 70

Author(s):

Roger D. Weiss ◽

Jennifer Sharpe Potter ◽

Margaret L. Griffin ◽

Scott E. Provost ◽

Garrett M. Fitzmaurice ◽

...

Keyword(s):

Clinical Trials ◽

Drug Abuse ◽

Addiction Treatment ◽

Opioid Addiction ◽

Prescription Opioid ◽

Drug Abuse Treatment ◽

Long Term Outcomes ◽

National Drug ◽

Abuse Treatment

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Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials

Blood Cancer Journal ◽

10.1038/s41408-018-0102-7 ◽

2018 ◽

Vol 8 (7) ◽

Cited By ~ 22

Author(s):

Sikander Ailawadhi ◽

Susanna Jacobus ◽

Rachael Sexton ◽

Alexander K. Stewart ◽

Angela Dispenzieri ◽

...

Keyword(s):

Multiple Myeloma ◽

Clinical Trials ◽

Cooperative Group ◽

Race Ethnicity

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A call for consensus in defining efficacy in clinical trials for opioid addiction: combined results from a systematic review and qualitative study in patients receiving pharmacological assisted therapy for opioid use disorder

Trials ◽

10.1186/s13063-019-3995-y ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 2

Author(s):

Brittany B. Dennis ◽

Nitika Sanger ◽

Monica Bawor ◽

Leen Naji ◽

Carolyn Plater ◽

...

Keyword(s):

Clinical Trials ◽

Addiction Treatment ◽

Treatment Effectiveness ◽

Methadone Treatment ◽

Population Level ◽

Opioid Addiction ◽

Complex Nature ◽

Opioid Use ◽

Structured Interviews ◽

Patient Reported

Abstract Background Given the complex nature of opioid addiction treatment and the rising number of available opioid substitution and antagonist therapies (OSAT), there is no ‘gold standard’ measure of treatment effectiveness, and each successive trial measures a different set of outcomes which reflect success in arbitrary or opportune terms. We sought to describe the variation in current outcomes employed across clinical trials for opioid addiction, as well as determine whether a discrepancy exists between the treatment targets that patients consider important and how treatment effectiveness is measured in the literature. Methods We searched nine commonly used databases (e.g., EMBASE, MEDLINE) from inception to August 1, 2015. Outcomes used across trials were extracted and categorized according to previously established domains. To evaluate patient-reported goals of treatment, semi-structured interviews were conducted with 18 adults undergoing methadone treatment. Results We identified 60 trials eligible for inclusion. Once outcomes were categorized into eight broad domains (e.g., abstinence/substance abuse), we identified 21 specific outcomes with furthermore 53 subdomains and 118 measurements. Continued opioid use and treatment retention were the most commonly reported measures (46%, n = 28). The majority of patients agreed that abstinence from opioids was a primary goal in their treatment, although they also stressed goals under-reported in clinical trials. Conclusions There is inconsistency in the measures used to evaluate the effectiveness of OSATs. Individual and population level decision making is being guided by a standard of effect considered useful to researchers yet in direct conflict with what patients deem important. Trial registration PROSPERO, CRD42013006507.

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