What is a Clinical Trial Study?

A clinical trial study is intended to add to medical knowledge about a specific condition; it involves research using human volunteers, who are also called study participants.

Clinical trials are a type of research that studies new treatments and tests and determine their effects on human health outcomes. Learn if volunteering for clinical trials is right for you.

There are 2 main types of clinical studies: clinical trials (also called interventional studies) and observational studies.

Interventional Studies

An interventional study tests (or tries out) an intervention⁠—a potential new drug, device, activity, or procedure⁠—in people. It is also commonly referred to as a clinical trial.

In a clinical trial, study participants receive specific interventions based on the research plan or protocol created by the investigators. These interventions may be products (such as drugs or appliances), procedures, or changes to participants' behavior, such as diet.

Clinical trials may compare a brand-new medical approach to a standard one that is already available, to a placebo that contains zero active ingredients, or to no intervention. Some clinical trials compare interventions that are readily available to each other.

When a new treatment or approach is being studied, it's not usually known whether it will be beneficial, harmful, or no different than available alternatives (including no intervention). The study investigators try to determine the initial safety and efficacy of the intervention by measuring specific outcomes in the study participants. For example, the investigators may give a drug or treatment to study participants who have high blood pressure to see if their blood pressure decreases or not.

Observational Studies

Investigators evaluate health outcomes in groups of participants based on a research plan or protocol.

Study participants may receive interventions (which can include medical products such as drugs or devices) or procedures as part of their regular medical care, but participants are not assigned to specific interventions by the investigator (like in a clinical trial). For example, study investigators may observe a group of older adults to learn more about the effects of different lifestyles on heart health.

Who Conducts Clinical Studies?

Clinical studies are led by a principal investigator, most often a medical doctor. These studies also have a research team that may be composed of doctors, nurses, social workers, and other health care professionals.

Clinical studies can be sponsored or funded by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies, including the National Institutes of Health, the US Department of Defense, and the US Department of Veterans Affairs. Doctors, health care providers, and other individuals can also sponsor any clinical research.

Where Are Clinical Trials Conducted?

Clinical trials can be conducted in many locations, such as hospitals, universities, doctors' offices, and community clinics. The location will depend on who is conducting the study.

Reasons for Conducting Clinical Studies

Clinical research studies are carefully designed to add to medical knowledge related to treating, diagnosing, and preventing diseases or conditions. Some common reasons for conducting clinical studies are the following:

• Evaluating one or more interventions (such as drugs, medical devices, approaches to surgery, or radiation treatment) for treating a certain disease, syndrome, or condition.
• Finding ways to prevent the onset or recurrence of a disease/condition, which can include medicines, vaccines, or lifestyle changes, among other approaches.
• Evaluating one or more interventions focused on identifying or diagnosing a particular disease/condition.
• Examining methods for identifying a disease/condition or the risk factors for that condition.
• Discovering and measuring ways to improve the quality of life through supportive care for people with chronic illnesses.

Who Can Participate in a Clinical Research Study?

Clinical studies have standards in outlining who can participate. These are called eligibility criteria and are listed in the study protocol. Some research studies seek participants who have the illnesses or conditions that will be studied, other studies are looking for healthy participants, and some studies are limited to a predetermined group of people who are asked by researchers to enroll.

Eligibility. The factors that allow someone to participate in a clinical study are called inclusion criteria, and the factors that disqualify someone from participating are called exclusion criteria. They are based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

How Are Clinical Research Participants Protected?

Informed consent is a process used by researchers to provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll or continue to participate in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks, potential benefits, and alternatives to the study. In addition to the informed consent form, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding.

Generally, a person must sign an informed consent document before joining a study to show that they were given information on the risks, potential benefits, and alternatives and that they understand these factors. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.

Institutional review boards. Each federally supported clinical study of a drug, biological product, or medical device regulated by the FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community. Its role is to ensure that the study is ethical and that the rights and welfare of participants are protected. This includes ensuring that research risks are minimized and reasonable in relation to any potential benefits, among other responsibilities. The IRB also reviews the informed consent document.

In addition to being monitored by an IRB, some clinical research studies are also monitored by data monitoring committees (also called data safety and monitoring boards).

Various Federal agencies, including the Office of Human Subjects Research Protection and the FDA, have the authority to determine whether certain clinical study sponsors adequately protect research participants.

Join Paid Clinical Trials in Tampa, FL!

Participating in a clinical trial can help in discovering the medicines of the future.

If you are interested in Paid Medical Trials at Santos Research Center, Corp., please contact us at (813) 249-9100 or visit us at 5927 Webb Rd Tampa, FL 33615.