“Of course much remains to know, but we know how to learn: through scientific research.”
- Mario Bunge
What is Clinical Research?
Clinical research is medical research that involves people like you. When you volunteer to take part in clinical research, you help doctors and researchers learn more about disease and improve health care for people in the future. Clinical research includes all research that involves people. Types of clinical research include:
Epidemiology, which improves the understanding of a disease by studying patterns, causes, and effects of health and disease in specific groups.
Behavioral, which improves the understanding of human behavior and how it relates to health and disease.
Health services, which looks at how people access health care providers and health care services, how much care costs, and what happens to patients as a result of this care.
Clinical trials, which evaluate the effects of an intervention on health outcomes.
“TopLine was born out of the tremendous need for research centers that will follow through and make meaningful contributions to clinical trials – specifically with patient recruitment and top quality clinical data.”
— Lacey Powers, MSJ, Founder & GM
What are Clinical Trials?
Clinical trials are part of clinical research and are at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. Clinical trials can study:
New drugs or new combinations of drugs
New ways of doing surgery
New medical devices
New ways to use existing treatments
New ways to change behaviors to improve health
New ways to improve the quality of life for people with acute or chronic illnesses.
The goal of clinical trials is to determine if these treatment, prevention, and behavior approaches are safe and effective. People take part in clinical trials for many reasons. Healthy volunteers say they take part to help others and to contribute to moving science forward. People with an illness or disease also take part to help others, but also to possibly receive the newest treatment and to have added (or extra) care and attention from the clinical trial staff. Clinical trials offer hope for many people and a chance to help researchers find better treatments for others in the future.
What are the Phases of Clinical Trials?
Clinical trials are conducted in a series of steps called “phases.” Each phase has a different purpose and helps researchers answer different questions.
Phase I trials: Researchers test a drug or treatment in a small group of people (20–80) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.
Phase II trials: The new drug or treatment is given to a larger group of people (100–300) to determine its effectiveness and to further study its safety.
Phase III trials: The new drug or treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely.
Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment’s benefits, and optimal use.
How Does Research Make a Difference to Me and My Family?
Only through clinical research can we gain insights and answers about the safety and effectiveness of treatments and procedures. Groundbreaking scientific advances in the present and the past were possible only because of participation of volunteers, both healthy and those with an illness, in clinical research. Clinical research requires complex and rigorous testing in collaboration with communities that are affected by the disease. As research opens new doors to finding ways to diagnose, prevent, treat, or cure disease and disability, clinical trial participation is essential to help us find the answers.
