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Understanding Clinical Trials and Clinical Studies in Paris, TX

Within the field of clinical research, terminology, including terms like clinical trial, clinical study, and clinical research, are all related concepts associated with the field of research.

There are two types of clinical studies we conduct in Paris, TX:

1. Interventional Clinical Trials

Our interventional clinical studies in Paris, TX test an intervention (possibly a treatment) with or without placebos. The interventions most often studied include:

Medical product, drug, or device
Procedures
Changes to participants' behavior, such as diet

2. Observational Studies

Observational clinical studies at our Paris, TX facility collect health information about clinical trial participants without making changes to their medical care. Unlike interventional clinical trials, researchers do not assign participants to a specific treatment or procedure.

Study Phases

At our Paris, TX clinic, the clinical studies have four phases of study, or steps. You will notice when you see the name of a clinical trial, it includes Phase I, II, III, or IV. The phases may also be written without roman numerals, such as Phase 1, 2, 3, or 4. Detailed below are what each phase entails:

Phase 1:

Researchers will test a pre-selected drug or treatment on a small group of patients (20-100) for the first time. This is to learn about the safety and side effects of the drug or treatment.

Phase 2:

The drug or treatment is given to a larger group of patients (100-300) to determine its effectiveness and to further evaluate safety.

Phase 3:

The drug or treatment is given to a large group of participants (1,000-3,000) to verify effectiveness, monitor side effects, compare it with similar treatments, and collect additional information that will allow the new drug or treatment to be used safely.

Phase 4:

After the drug is approved by the FDA and made available to the public, researchers track safety in the general population, receiving additional information about the drug or treatment benefit and optimal use.