scholarly journals The State of Lupus Clinical Trials: Minority Participation Needed

2019 ◽  
Vol 8 (8) ◽  
pp. 1245
Author(s):  
Saira Z. Sheikh ◽  
Nicole I. Wanty ◽  
Joncel Stephens ◽  
Kristen D. Holtz ◽  
Sheryl McCalla
Keyword(s):  
Clinical Trials ◽  
African Americans ◽  
Symptom Severity ◽  
Quality Care ◽  
Treatment Options ◽  
The United States ◽  
Minority Populations ◽  
Healthcare Staff ◽  
Minority Participation ◽  
New Treatment

In the United States, the reported prevalence of lupus is 100,000 to 500,000 patients. Lupus disproportionately affects minority populations, including African Americans and Latinos, and the associated health disparities are substantial. Women are at a higher risk of lupus than men and lupus prevalence is the highest in African Americans and Latinos compared to non-Hispanic whites. African Americans and Latinos also have increased disease symptom severity, experience more lupus-related complications, and have a two- to three-fold mortality rate compared to non-Hispanic Whites. Lupus clinical trials offer opportunities for quality care and can result in new treatment options, but African Americans and Latinos are underrepresented in clinical trials because of substantial patient- and provider-side barriers. In conjunction with the limited knowledge of clinical trials that potential participants may have, the healthcare staff approaching participants have limited time to adequately educate and explain the aspects of clinical trials. Indeed, ninety percent of clinical trials fail to meet their recruitment goals on time, so a multi-faceted approach is necessary to address the issue of low minority participation in clinical trials.

Dystrophinopathies and Limb-Girdle Muscular Dystrophies

2017 ◽  
Vol 48 (04) ◽  
pp. 262-272 ◽  
Author(s):  
Anna Sarkozy ◽  
Mariacristina Scoto ◽  
Francesco Muntoni ◽  
Joana Domingos
Keyword(s):  
Clinical Trials ◽  
Treatment Options ◽  
Shoulder Girdle ◽  
Muscle Disease ◽  
Standards Of Care ◽  
Muscular Dystrophies ◽  
New Treatment ◽  
Shoulder Girdle Muscles ◽  
Independent Ambulation ◽  
Duchenne's Muscular Dystrophy

AbstractMuscular dystrophies are a heterogeneous group of inherited diseases. The natural history of these disorders along with their management have changed mainly due to a better understanding of their pathophysiology, the evolution of standards of care, and new treatment options. Dystrophinopathies include both Duchenne's and Becker's muscular dystrophies, but in reality they are a spectrum of muscle diseases caused by mutations in the gene that encodes the protein dystrophin. Duchenne's muscular dystrophy is the most common form of inherited muscle disease of childhood. The current standards of care considerably prolong independent ambulation and survival. Several therapeutic options either aiming at substituting/correcting the primary protein defect or limiting the progression of the dystrophic process are currently being explored in clinical trials.Limb-girdle muscular dystrophies (LGMDs) are rare and heterogeneous conditions, characterized by weakness and wasting of the pelvic and shoulder girdle muscles. Originally classified into dominant and recessive, > 30 genetic forms of LGMDs are currently recognized. Further understanding of the pathogenic mechanisms of LGMD will help identifying novel therapeutic approaches that can be tested in clinical trials.

scholarly journals Clinical Trial Information As a Measure of Quality Cancer Care

2010 ◽  
Vol 6 (3) ◽  
pp. 170-171 ◽  
Author(s):  
Wei Chua ◽  
Stephen J. Clarke
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Care ◽  
Treatment Options ◽  
Small Cell ◽  
Small Cell Lung ◽  
Quality Cancer Care ◽  
Improved Outcomes ◽  
New Treatment ◽  
Clinical Trial Information

Participation in clinical trials enables patients to access new treatment options. Evidence shows improved outcomes in participants compared with nonparticipants in non–small-cell, lung, breast, colorectal, and testicular cancers.

scholarly journals The Systemic Exclusion of Native Americans from Cancer Clinical Trials.

2021 ◽  
Author(s):  
Joseph Angel De Soto ◽  
Gabriel Selassie ◽  
Gilberta Yazzie
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Native American ◽  
African Americans ◽  
Native Americans ◽  
Ethnic Minorities ◽  
Health Care Disparities ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Unnecessary Death

Introduction: A major source of health care disparities derives from the underrepresentation of ethnic minorities in clinical trials. The inclusion of ethnic minorities is necessary to generalize the results in terms of efficacy and toxicology of medications in cancer treatment. Methodology: In this retrospective study, 80 cancer clinical trials with an aggregate of 278,470 participants performed within the last ten years were selected at random. The number of ethnic minorities participating and inclusion of them in the results were evaluated. Results: Only, 42.5% of cancer clinical trials reported the ethnic background of participants in their trials while even less 5% reported the efficacy or toxicology of the therapeutic intervention for ethnic minorities. Whites, Hispanics, African Americans, and Native Americans make up 60.1%, 18.5%, 13.4% and 1.5% of the population they made up 85.3%, 2.54%, 7.6% and 0.12% of the participants that reported ethnicity, respectively. Out of 278,470 participants in cancer clinicals trials only 133 (0.048%) could be identified as Native American . Conclusion: Native Americans were nearly completely excluded from cancer clinical trials. African Americans and Hispanics were greatly underrepresented. Cancer Clinical trials may not be generalizable and have been inherently racist in the United States. This has led to the unnecessary death and suffering of Native Americans from cancer.

scholarly journals Coronavirus Disease Health Care Delivery Impact on African Americans

2020 ◽  
pp. 1-3
Author(s):  
Rahul Chaturvedi ◽  
Rodney A Gabriel
Keyword(s):  
African Americans ◽  
Care Delivery ◽  
Primary Care Providers ◽  
The United States ◽  
High Risk Population ◽  
Minority Populations ◽  
Care Providers ◽  
High Quality ◽  
Treatment Regimens ◽  
Implicit Biases

ABSTRACT The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected over 1.5 million individuals and led to over 91, 000 deaths in the United States (US) alone as of May 20th, 2020. Minority populations, however, continue to be a high-risk population to contract the SARS-CoV-2 infection. While socioeconomic inequality may help to explain why minority ethnic populations are contracting the SARS-CoV-2 in larger proportions, the reason for elevated mortality rates in African Americans is still unknown. African Americans are less likely than whites to utilize high-quality hospitals, ambulatory care services, and regular primary care providers; this is most likely a result of barriers to accessing high quality treatment, as African Americans have substantially higher uninsured rates. However, previous reports have shown that regardless of insurance status, African Americans are more likely to be directed toward lower quality treatment plans compared to their white counterparts, and that physicians carry implicit biases that negatively impact treatment regimens for these minority populations. While income, education, and access to healthcare should be revised in due time, in the short term physicians should do everything possible to learn about implicit biases that may exist in healthcare, as the first step to minimize implicit biases is to recognize that they exist.

scholarly journals Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials

2016 ◽  
Vol 12 (6) ◽  
pp. 556-563 ◽  
Author(s):  
Mona N. Fouad ◽  
Aras Acemgil ◽  
Sejong Bae ◽  
Andres Forero ◽  
Nedra Lisovicz ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
African American ◽  
African Americans ◽  
Patient Navigation ◽  
Comprehensive Cancer Center ◽  
Trial Participation ◽  
Cancer Clinical Trials ◽  
Minority Participation ◽  
Navigation Support

Purpose: Less than 10% of patients enrolled in clinical trials are minorities. The patient navigation model has been used to improve access to medical care but has not been evaluated as a tool to increase the participation of minorities in clinical trials. The Increasing Minority Participation in Clinical Trials project used patient navigators (PNs) to enhance the recruitment of African Americans for and their retention in therapeutic cancer clinical trials in a National Cancer Institute–designated comprehensive cancer center. Methods: Lay individuals were hired and trained to serve as PNs for clinical trials. African American patients potentially eligible for clinical trials were identified through chart review or referrals by clinic nurses, physicians, and social workers. PNs provided two levels of services: education about clinical trials and tailored support for patients who enrolled in clinical trials. Results: Between 2007 and 2014, 424 African American patients with cancer were referred to the Increasing Minority Participation in Clinical Trials project. Of those eligible for a clinical trial (N = 378), 304 (80.4%) enrolled in a trial and 272 (72%) consented to receive patient navigation support. Of those receiving patient navigation support, 74.5% completed the trial, compared with 37.5% of those not receiving patient navigation support. The difference in retention rates between the two groups was statistically significant (P < .001). Participation of African Americans in therapeutic cancer clinical trials increased from 9% to 16%. Conclusion: Patient navigation for clinical trials successfully retained African Americans in therapeutic trials compared with non–patient navigation trial participation. The model holds promise as a strategy to reduce disparities in cancer clinical trial participation. Future studies should evaluate it with racial/ethnic minorities across cancer centers.

scholarly journals Global Dietary Patterns and Functional Gastrointestinal Disorders

Children ◽  
2020 ◽  
Vol 7 (10) ◽  
pp. 152
Author(s):  
Cara Hannah Axelrod ◽  
Miguel Saps
Keyword(s):  
Clinical Trials ◽  
Treatment Options ◽  
Functional Gastrointestinal Disorders ◽  
The United States ◽  
Gastrointestinal Disorders ◽  
Dietary Interventions ◽  
Nonpharmacological Treatment ◽  
Abdominal Symptoms ◽  
The World ◽  
Consensus View

Functional Gastrointestinal Disorders (FGIDs) are common. In the United States alone, approximately 25 million Americans are estimated to have at least one FGID. Nonpharmacological treatment options include psychological/behavioral approaches, and dietary interventions that can vary across countries. The aim of this review is to evaluate the available evidence for dietary interventions for the treatment of childhood FGIDs amongst various cultures and regions of the world. This review includes clinical trials of dietary therapies for the treatment of FGIDs in children posted on or before 13 July 2020 in PubMed. Overall, the consensus view suggests that the westernization of diets is linked to the development of FGIDs, and diets low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAPs) may reduce abdominal symptoms. However, more work is needed to confirm these findings.

scholarly journals 1167. Trends in Multi-Drug-Resistant Gonorrhea, Gonococcal Isolate Surveillance Project, United States, 1987–2016

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S352-S352
Author(s):  
Sancta St. Cyr ◽  
Ellen Kersh ◽  
Hillard Weinstock ◽  
Elizabeth Torrone
Keyword(s):  
United States ◽  
Antimicrobial Susceptibility ◽  
Treatment Options ◽  
The United States ◽  
Drug Resistant ◽  
Appropriate Treatment ◽  
High Prevalence ◽  
Agar Dilution ◽  
Male Patients ◽  
New Treatment

Abstract Background Neisseria gonorrhoeae’s ability to develop resistance to antibiotics used for treatment and a limited development of new therapies have made this organism one of three urgent threat pathogens in the United States. We provide the first report of US trends in multi-drug-resistant (MDR) and extensively-drug-resistant (XDR) gonorrhea. Methods The Gonococcal Isolate Surveillance Project (GISP) monitors trends in antimicrobial susceptibility in N. gonorrhoeae in the United States. Antimicrobial susceptibility testing by agar dilution is performed on urethral isolates from male patients at participating STD clinics. Minimum inhibitory concentration (MIC) are used to identify isolates with resistance or reduced susceptibility using the following criteria: fluoroquinolones (ciprofloxacin [MIC ≥1.0 μg/mL]) and elevated MICs to cephalosporins (cefixime [MIC ≥0.25 μg/mL], ceftriaxone [MIC ≥0.25 μg/mL]) and macrolides (azithromycin [MIC ≥1.0 μg/mL before 2005 and ≥2.0 μg/mL 2005–2016]). In this analysis, MDR is defined as resistance or elevated MICs to ≥2 classes of antimicrobials; XDR as resistance or elevated MICs to ≥3 classes. This classification excludes penicillin and tetracycline due to their long history and high prevalence of gonococcal resistance. Results During 1987–2016, 159,445 isolates were collected through GISP. In 1998, the first MDR strains were identified. Although only 0.04% of isolates that year, these isolates showed elevated MICs to both cephalosporins and macrolides. By 2010, 1.0% of GISP isolates were MDR with elevated MICs or resistance to two of the cephalosporins, macrolides, or fluoroquinolones. In 2011, the proportion of isolates that were MDR peaked at 1.3%. In 2016, after minor fluctuations, 1.1% of GISP isolates were considered MDR. Only one occurrence of XDR, in 2011, has been seen in GISP. The strain was resistant to fluoroquinolones with elevated MICs to both cephalosporins and macrolides. Conclusion MDR and XDR gonorrhea have remained low over the past three decades; however, dual treatment with cephalosporins and macrolides is the last remaining recommended therapy for N. gonorrhoeae. Until new treatment options become available, a combination of surveillance and ensuring appropriate treatment are needed to delay further resistance. Disclosures All authors: No reported disclosures.

scholarly journals Surveillance and Treatment of Non-Muscle-Invasive Bladder Cancer in the USA

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Daniel A. Barocas ◽  
Denise R. Globe ◽  
Danielle C. Colayco ◽  
Ahunna Onyenwenyi ◽  
Amanda S. Bruno ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Treatment Options ◽  
Unmet Need ◽  
Patient Characteristics ◽  
The United States ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
The Usa ◽  
New Treatment ◽  
Muscle Invasive

Seventy percent of newly diagnosed bladder cancers are classified as non-muscle-invasive bladder cancer (NMIBC) and are often associated with high rates of recurrence that require lifelong surveillance. Currently available treatment options for NMIBC are associated with toxicities that limit their use, and actual practice patterns vary depending upon physician and patient characteristics. In addition, bladder cancer has a high economic and humanistic burden in the United States (US) population and has been cited as one of the most costly cancers to treat. An unmet need exists for new treatment options associated with fewer complications, better patient compliance, and decreased healthcare costs. Increased prevention of recurrence through greater adherence to evidence-based guidelines and the development of novel therapies could therefore result in substantial savings to the healthcare system.

scholarly journals Immunotherapies in Genitourinary Oncology: Where Are We Now? Where Are We Going?

Cancers ◽  
2021 ◽  
Vol 13 (20) ◽  
pp. 5065
Author(s):  
Albert Jang ◽  
David M. Adler ◽  
Grant P. Rauterkus ◽  
Mehmet A. Bilen ◽  
Pedro C. Barata
Keyword(s):  
Clinical Trials ◽  
Immune Checkpoint ◽  
Checkpoint Inhibitors ◽  
Treatment Options ◽  
The United States ◽  
The Past ◽  
United States Food ◽  
States Food ◽  
Genitourinary Cancers ◽  
Tumor Types

For decades, limited options existed to treat metastatic genitourinary cancers, including treatment options that could be classified as immunotherapy. Historically, immunotherapy centered on systemic cytokines for the treatment of metastatic kidney cancer, which had several adverse effects, as well as the Bacillus Calmette–Guérin vaccine for non-metastatic bladder cancer. Within the past decade, advances in immunotherapy have led to several approvals from the United States Food and Drug Administration, particularly in the field of immune checkpoint inhibition. Immune checkpoint inhibitors (ICIs) are now being used extensively to treat multiple solid tumors, including kidney and bladder cancers, and they are also being tested in many other cancers. Despite encouraging data from phase 2/3 clinical trials, less is known about biomarkers that may predict better response to ICIs. The effect of ICIs in genitourinary cancers is heterogeneous, with some tumor types having little clinical data available, or ICIs having limited activity in other tumors. In this review, we briefly discuss approved immunotherapy agents prior to the time of ICIs. Then, given the emergence of this class of agents, we summarize the several important ICIs and the clinical trials that led to their approval. Finally, we mention ongoing and future clinical trials.

scholarly journals The Underrepresentation of Minorities and Non-Generalizability of Breast Cancer Clinical Trials?

2021 ◽  
Author(s):  
Joseph Angel De Soto
Keyword(s):  
Breast Cancer ◽  
United States ◽  
Clinical Trials ◽  
African Americans ◽  
Native Americans ◽  
Ethnic Minorities ◽  
Minority Groups ◽  
The United States ◽  
Cancer Clinical Trials ◽  
High Death

Introduction This year 43,000 women will die from breast cancer in the United States. African Americans and Native Americans though less likely to get breast cancer, once diagnosed they are much more likely to die from breast cancer. This increased death rate may in part be due to the non-generalizability of breast cancer clinical trials. In this study, we evaluate the participation of ethnic minorities from breast cancer clinical trials. Methodology In this study, fifty-six breast cancer clinical trials completed in the last ten years in the United States were evaluated for the inclusion of ethnic minorities in the breast cancer clinical trials. Results Only 21% of breast cancer clinical trials include information on ethnicity in the methodology while only 7% provided any information on the effect or toxicity of the therapeutic intervention in minority groups while 100% report the results for Whites. Though Whites only make up 60.1% of the population, they were 87.5% of the clinical trial participants while African Americans were 6.2%, Hispanics 3.1%, Asians 2.9% and Native Americans were 0.2% of the participants. Conclusion Racial minorities have been underrepresented in breast cancer clinical trials which may contribute to unnecessarily high death rates in these groups while suggesting limited generalizability of breast cancer clinical trials.

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