Understanding
Clinical Research
Clinical trials are research studies that help scientists and healthcare professionals develop new ways to prevent, diagnose, and treat diseases. These studies evaluate medications, therapies, behavioral interventions, and medical technologies to determine whether they are safe and effective.
The Clinical Research Center provides clear, accessible information about how clinical trials work, why participation matters, and how individuals can explore opportunities to contribute to advancing healthcare.
Access to research opportunities and trusted information is essential for helping individuals make informed decisions about participation. Increasing awareness and representation in clinical trials helps ensure medical advances benefit all communities.
THE PULSE ON Clinical Research
You may consider learning more about clinical research if you:
Are interested in contributing to medical discoveries
Have a health condition being studied in clinical trials
Want access to new treatment approaches being tested
Are interested in prevention, lifestyle, or behavioral health research
Want to learn how research participation supports future healthcare advancements
Clinical trials vary in purpose and design. Some studies test treatments, while others observe health outcomes or evaluate prevention strategies.
What is a clinical trial?
Clinical trials are research studies that help doctors and scientists learn more about how to prevent, detect, or treat health conditions. They test new approaches—like medications, therapies, or care strategies—to see what works and for whom.
Participating in a clinical trial means contributing to knowledge that can improve care for future generations.
Why do clinical trials matter for diverse communities?
Not all treatments work the same for everyone. When people from different backgrounds, races, and life experiences are included in clinical trials, researchers can better understand how care impacts real communities.
Greater representation helps ensure that new treatments are safe, effective, and relevant for everyone—not just a limited group.
How are clinical trials conducted?
Clinical trials follow a structured process to ensure safety and accuracy. They typically move through phases, starting with small groups and expanding over time.
Participants are guided by medical professionals, and each step is carefully monitored to track results and protect participant well-being.
Are clinical trials safe and regulated?
Yes. Clinical trials must meet strict guidelines before they begin. They are reviewed and monitored by regulatory bodies and ethics committees to protect participants.
You are always informed about the study, and participation is completely voluntary—you can leave at any time.
What are the benefits of participating in a clinical trial?
Participants may gain access to new potential treatment options, closer medical monitoring, and the opportunity to play an active role in their health journey.
Equally important, participation helps advance research that can lead to better care for your community and future generations.
How do I find a clinical trial that’s right for me?
There are many ways to explore clinical trials, including trusted community organizations, healthcare providers, and online tools such as ClinicalTrials.gov.
Look for studies that match your health needs, location, and preferences—and take your time reviewing your options.
Take the Clinical Trial Readiness Screening
Understanding
Clinical Trials
Clinical research studies help scientists understand diseases, develop new treatments, and improve prevention strategies.
Clinical trials evaluate medications, medical devices, behavioral interventions, and screening methods to determine whether they are safe and effective.
Participation in research helps advance medical knowledge and contributes to the development of better healthcare for future generations.
Common Types of Clinical Research Studies
▪ Treatment trials
Evaluate new medications, therapies, or medical procedures.
▪ Prevention studies
Test strategies that may reduce the risk of disease, including lifestyle interventions or vaccines.
▪ Screening studies
Assess new methods for detecting diseases earlier.
▪ Behavioral research
Explore how lifestyle, mental health, or social factors affect health outcomes.
▪ Observational studies
Researchers observe participants over time to better understand health patterns and disease progression.
▪ Health services research
Examines how healthcare delivery can improve patient outcomes and access to care.
▪ Genetic and precision medicine research
Studies how genetics influence disease risk and treatment responses.
▪ Community health research
Focuses on improving health outcomes at the population and community level.
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Participant Protections in Clinical Trials
▪ Informed consent
Participants receive clear information about the purpose, procedures, risks, and benefits before enrolling.
▪ Ethics review boards
Institutional Review Boards (IRBs) review studies to ensure participant safety and ethical research practices.
▪ Voluntary participation
Participants can leave a study at any time without penalty.
▪ Privacy protections
Personal health information is protected according to strict confidentiality standards.
▪ Safety monitoring
Researchers continuously monitor study results to ensure participant well-being.
▪ Regulatory oversight
Clinical trials must follow federal regulations and scientific standards.
Research participation is guided by ethical principles designed to protect participants and ensure that studies are conducted responsibly.
What Participation May Involve
Participating in a clinical study may include:
▪ Completing health questionnaires
▪ Attending research clinic visits
▪ Providing blood samples or other biological samples
▪ Testing new treatments or interventions
▪ Participating in lifestyle or behavioral programs
▪ Allowing researchers to track health outcomes over time
Participation requirements vary depending on the type of study.
Questions to Consider Before Joining a Study
If you are considering participation in a clinical trial, it may be helpful to ask:
▪ What is the purpose of this study?
▪ What procedures or treatments are involved?
▪ How long will the study last?
▪ What are the potential risks and benefits?
▪ Will participation affect my current medical care?
▪ Are there any costs or compensation involved?
Discussing research participation with a healthcare provider can help individuals make informed decisions about whether a study is right for them.
Explore Clinical Research Opportunities
Clinical trials and research studies are conducted at universities, hospitals, research institutions, and community health organizations. Individuals interested in participating in research can explore studies through trusted registries and speak with healthcare providers about potential opportunities.
Learning about clinical research is an important step toward advancing health innovation and improving care for future generations.
The Six Phases
of Clinical Trials
Clinical research is conducted in sequential phases designed to evaluate the safety, effectiveness, and long-term impact of medical interventions such as drugs, vaccines, devices, or behavioral treatments. Each phase answers different scientific questions and involves progressively larger populations.
Where Scientific Discovery Begins
Before any treatment is tested in humans, researchers conduct preclinical studies to evaluate whether the intervention shows promise and acceptable safety. These studies are typically performed in laboratories using cell cultures and animal models to understand how a treatment interacts with biological systems. Scientists examine toxicity, biological activity, and pharmacokinetics—how a substance is absorbed, distributed, metabolized, and eliminated by the body. The goal of preclinical research is to determine whether a treatment has enough scientific evidence and safety data to justify testing in human participants. Only treatments that demonstrate scientific promise and acceptable safety move forward to human clinical trials.
Early Human Insights Through Micro-Dosing
Phase 0 trials are small exploratory studies conducted with a very limited number of participants, usually around 10 to 15 individuals. In these studies, participants receive extremely small “micro-doses” of the investigational treatment that are too low to produce therapeutic effects. The purpose of Phase 0 research is to observe how the drug behaves in the human body and whether it functions as predicted based on laboratory and animal studies. Although these trials do not measure treatment effectiveness, they provide valuable early data that helps researchers determine whether further clinical development should continue. Phase 0 trials help researchers quickly determine whether a potential treatment is worth studying further.
Understanding Safety in Humans
Phase I clinical trials represent the first stage in which a new treatment is tested in human participants. These studies typically involve between 20 and 100 volunteers and focus primarily on evaluating safety and tolerability. Researchers carefully monitor participants to determine how the treatment is processed by the body and to identify the safest dosage range. By studying how the drug is absorbed, metabolized, and eliminated, investigators gain essential information about the treatment’s biological behavior and potential side effects. The primary goal of Phase I trials is to identify a safe dosage and understand how the treatment behaves in the human body.
Does the Treatment Work?
Phase II clinical trials involve a larger group of participants who have the disease or condition the treatment is intended to address. These studies typically include between 50 and 300 patients and aim to evaluate whether the treatment demonstrates therapeutic effectiveness while continuing to monitor safety. Researchers may compare the experimental treatment to a placebo or existing therapy to better understand its benefits and potential risks. Results from this phase help determine whether the treatment shows enough promise to justify larger and more rigorous studies. Phase II trials provide the first clear evidence of whether a treatment may actually benefit patients
Proving Effectiveness at Scale
Phase III trials are large, carefully controlled studies that test the treatment in hundreds or even thousands of participants across multiple research sites. These trials are designed to confirm effectiveness, compare the treatment with current standard therapies, and provide a comprehensive understanding of potential risks and benefits. Because they involve diverse patient populations and rigorous study designs, Phase III trials produce the scientific evidence needed to support regulatory approval and broader clinical use. Successful Phase III trials provide the evidence required for regulatory agencies to approve a treatment for public use.
Phase IV: Post-Market Monitoring
Phase IV research occurs after a treatment has been approved and is available to the public. These studies monitor the long-term effectiveness and safety of the intervention in real-world settings, often involving large populations over extended periods of time. Researchers look for rare or delayed side effects that may not have appeared in earlier trials and assess how the treatment performs across diverse patient groups. This ongoing monitoring helps improve treatment guidelines and ensures continued patient safety. Phase IV studies ensure treatments remain safe, effective, and beneficial in real-world healthcare settings.
Clinical trials are carefully designed studies conducted with volunteers to evaluate medical, surgical, or behavioral interventions. These studies help determine whether new treatments or prevention strategies are safe and effective.
Clinical research may include:
Treatment trials evaluating medications or therapies
Prevention studies testing lifestyle or screening approaches
Behavioral health research
Medical device testing
Observational studies that track health outcomes over time
All clinical trials must follow strict ethical and safety standards, and participants always have the right to ask questions and withdraw from a study at any time.
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