Clinical Trials Info for Nevadans

What is a Clinical Trial?

Clinical trials are voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. 

Clinical research is studies in which people participate as patients or healthy volunteers. The idea for a clinical research study often starts as a clinical trial in the laboratory.  The main two types of clinical research are called Observational Studies (also known as Non-Interventional Studies) and Clinical Trials (also known as Interventional Studies).

Non-Interventional or Observational Studies: Non-interventional studies are often known as observational studies. Observational studies occur when research is focused on identifying or analyzing changes that occur over time through monitoring habits, medical data, and biological samples.  Observational studies do not test medical interventions, like a drug or device, but may help identify treatment or prevention strategies.

Interventional Studies or Clinical Trials: Interventional studies are often known as clinical trials. Clinical trials are research studies that test the safety and effectiveness of medical, surgical, or behavioral intervention in people. They require people of every age, health status, race, gender, ethnicity, and cultural background to participate. Both healthy and those with diagnosed medical conditions can take part in clinical trials. 

Learn more about different types of clinical research here:

• What Are Clinical Trials and Studies? | National Institute on Aging (nih.gov)

Find Clinical Research Opportunities in Nevada

Interested in participating in a clinical research opportunity? Checkout a few Nevadan organizations that conduct clinical research below.

• Northern Nevada
• Southern Nevada (AB Clinical Trials)
• Southern Nevada (UNLV)
• Rural and Frontier Nevada (Cleveland Clinic)
• Rural and Frontier Nevada (Nevada Exploratory ADRC)

National Clinical Research Opportunities

• The All of Us Research Program funded through the National Institutes of Health is working to improve health care through research. Unlike research studies that focus on one disease, All of Us is building a diverse database that can inform thousands of studies.

• Clinicaltrials.gov is a registry and results database. Use the following tips to navigate the website to learn more about research opportunities available in Nevada. of publicly and privately supported clinical studies of human participants conducted around the world. This website not only shows open studies, but all clinical trials that have been conducted. Use the following tips to navigate the website to learn more about research opportunities available in Nevada.

  • Type in the condition or disease you want to learn more about. (Ex: Alzheimer’s, Heart Attack) 
  • If you have additional search criteria you would like to search, type in under “Other Terms”. (Ex: “heart attack” treatment)
  • If you would like to learn about a specific kind of intervention/ treatment, type the treatment under “Intervention/treatment” (Ex: Aspirin, Exercise) 
  • If you want to see all trials done in Nevada (even those that have concluded), type Nevada or a city or address under "Location" 

• NIH AllofUs Research Program
• Clinicaltrials.gov

Assembly Bill 214

During the 79th (2017) session of the Nevada Legislature, Assembly Bill (AB) 214 was passed. This bill requires the Division of Public and Behavioral Health (DPBH) to establish a program to encourage participation in clinical trials of drugs and medical devices by persons who are members of demographic groups that are underrepresented in such trials. This bill also requires each state or local governmental entity that conducts such trials to adopt a policy concerning the identification and recruitment of such persons to participate in those trials.

• Assembly Bill 214 Report

Diversity in Clinical Trials

Health and wellness is shaped by our physical and mental well-being. Our physical and mental wellbeing is influenced and defined by our biology, behavior, environment, society, social policies, and lived experiences.  The lived experiences of people vary based on many factors like race, age, socioeconomic status, sexual orientation, gender identity, geographic location and more.  Simply put, we are all different in many ways and similar in others. It is this diversity that clinical researchers should consider and include when creating, modifying, and studying medical initiatives, interventions, and therapeutics.
  

Diseases, disorders, therapeutics, and medications affect different populations differently. Historically, clinical trials often did not recruit participants who represented the individuals most affected by a particular condition. Rather, clinical research relied almost exclusively on white male study participants leading to gaps in understanding of diseases, conditions, preventative factors, and treatment effectiveness. In addition to this, historical atrocities and incidents have led to many communities developing and maintaining mistrust in clinical research and medical institutions.
  

This clinical research history has led to gaps in knowledge that impede comprehensive public health and medical understanding of medical conditions, preventative measures, and treatment effectiveness.  As a result, many initiatives and policies have been established to reduce inequities, discrimination, and mistrust while increasing accountability and diverse involvement.

This is reflected in the following national policies:

• 1974 National Research Act   
  • On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, thereby creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
• The Belmont Report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research  
  • A report that establishes the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.
• Establishment of Institutional Review Boards (IRB) by the National Research Act 
  • Institutional Review Boards, also known as IRB, are groups that have been formally designated to review and monitor research involving human subjects. The purpose of IRB review is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. 
• 1993 NIH Revitalization Act   
  • The NIH Revitalization Act of 1993, PL 103-43 (Public Health Service Act sec. 492B, 42 U.S.C. sec. 289a-2), signed into law on June 10, 1993, directed the NIH to establish guidelines for inclusion of women and minorities in clinical research The statute requires NIH to ensure that clinical trials are carried out in a manner sufficient to provide for a valid analysis of whether the variables being studied affect women or members of minority groups differently than other trial participants.
• 21^st Century Cures Act 
  • The 21st Century Cures Act, PL 114-255, enacted December 13, 2016, requires entities conducting applicable clinical trials submit results of valid analyses by sex/gender, race, and ethnicity in Clinicaltrials.gov. The statute further requires that NIH consider, as appropriate, whether the entity has complied with this reporting requirement when awarding any future grant to that entity; and that NIH encourage the reporting of the results of valid analysis through any additional means determined appropriate.
• 2024 Revisions to the Statistical Policy Directive No.15: Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity 
  • In March 2024, the U.S. Office of Management and Budget (OMB) published a set of revisions to the Statistical Policy Directive (SPD) No. 15: Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity providing significant changes to data collections established and utilized since 1997. The revisions incorporated culturally mindful practices and changes to the standardized language established nationally.

Within the state of Nevada, it is also acknowledged that it is only when the populations included in clinical research are fully reflective of the diversity of the country can we ensure that public health and medical interventions are mindful of manifestation differences. As such, Assembly Bill 214 was established to encourage the intentional diversification of clinical research within Nevada.  To learn more about why it is important to diversify clinical research, please visit the websites linked below.

• Collection of Race and Ethnicity Data in Clinical Trials — Guidance for Industry and Food and Drug Administration Staff
• Lack Of Diversity In Clinical Trials Presents Possible Health Consequences - National Public Radio
• Are Racial and Ethnic Minorities Less Willing to Participate in Health Research? | PLOS Medicine
• Why Diverse Clinical Trial Participation Matters | New England Journal of Medicine (nejm.org)
• Clinical Trial Diversity (phrma.org)

Resources for Nevadans Interested in Learning More about Clinical Research Opportunities

Interested in learning more about clinical research and opportunities available? Check out the resources linked below.

• Information for Research Subjects | Division of Research | University of Nevada, Las Vegas (unlv.edu)
• Human Research Volunteer Informational Videos | Health and Human Services
• Learn About Studies | ClinicalTrials.gov
• Protecting Data and Privacy | All of Us Research Program | NIH
• Principles of Clinical Trials | PHRMA
• FDA and Clinical Drug Trials: A Short History
• Advancing Healthcare in Nevada Through Research | Renown Health
• The Belmont Report | HHS.gov
• Institutional Review Boards Frequently Asked Questions | FDA

Resources for Researchers in Nevada

There are many organizations conducting clinical research within the State of Nevada. This section of the webpage is designed to provide researchers with resources that will aid in being culturally aware, responsive, sensitive, and literate. The State of Nevada is full of diversity. This diversity includes geographic location, socioeconomic status, race, ethnicity, age, language and more. 

The following resources take these factors into account.

• ADSD Language Access Plan ADA (nv.gov)
• Nevada Medicaid Language Access Plan (nv.gov)
• DPBH Language Access Plan (nv.gov)
• DWSS Language Access Plan (nv.gov)
• Division of Public and Behavioral Health -Office of Analytics Webpage
• Nevada Office of Minority Health and Equity Webpage
• Minority Health Report
• Health Equity Action Plan
• UNR Larson Institute
• Nevada Minority Health and Equity Coalition Webpage
• NMHEC Additional Reports and Publications
• CDC Places: Local Data for Better Health
• U.S. Office for Human Research Protections