What Are Clinical Trials?
Clinical trials are carefully designed research studies that evaluate medications, vaccines, medical devices, procedures, and diagnostic tests. These studies involve people—referred to as participants—and are conducted to determine whether an investigational product is safe and effective when compared to existing, approved options.
Without clinical trials, the development of new medicines, vaccines, cures, and medical technologies would not be possible. Every treatment available today has gone through this rigorous research process before reaching patients.
Examples of Products Studied in Clinical Trials
Clinical trials support innovation across many areas of healthcare, including:
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Vaccines: Influenza, Ebola, SARS-CoV-2 (COVID-19)
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Medications: Topical treatments for eczema, oral or injectable therapies for multiple sclerosis, liquid cold and cough medicines for children
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Medical Devices: Migraine-relief devices, dermatologic lasers, wearable technology for monitoring movement disorders such as Parkinson’s disease
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Diagnostics: COVID-19 and influenza swab tests, home pregnancy tests
At McAllen Research, most studies are interventional, meaning participants receive an investigational medical product. Some studies are observational, which may involve interviews, questionnaires, physical exams, or health monitoring without administering a new treatment.
Phases of Clinical Trials
Clinical trials are conducted in four phases, each designed to answer specific research questions. Data collected at every stage is carefully reviewed by regulatory authorities, including the U.S. Food and Drug Administration (FDA), before a product can move forward.
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Phase I (20–80 participants):
The investigational product is tested in humans for the first time to evaluate safety, identify side effects, and determine appropriate dosage ranges. This phase typically lasts less than one year. -
Phase II (Hundreds of participants):
The study expands to further assess safety and evaluate how well the product works. This phase may last several months or longer. -
Phase III (Thousands of participants):
Larger groups are studied to confirm effectiveness, monitor side effects, and compare the investigational product to existing treatments. This phase often takes several years and provides the data needed for FDA review. -
Phase IV (Post-Approval Studies):
After FDA approval and public availability, additional research may continue to evaluate long-term safety, benefits, and optimal use in broader populations.
All medical products—from flu vaccines and Alzheimer’s medications to pacemakers—must successfully complete this process before being offered on the commercial market.
Who Can Participate in Clinical Trials?
Clinical trials may involve healthy volunteers, individuals with chronic conditions such as diabetes or multiple sclerosis, or people with serious or treatment-resistant illnesses. For some participants, clinical trials provide access to potential new therapies when standard options are limited.
Commitment to Safety and Ethics
McAllen Research conducts all clinical studies in accordance with strict FDA regulations and ethical research standards. Participant safety, informed consent, and transparency are central to every study conducted at our site.
If you have questions about the clinical trial process or would like to learn about currently enrolling studies, McAllen Research staff are available to provide guidance and support.
Did You Know?
A common misconception is that “clinical trials” mean testing products already approved for sale. In reality, clinical trials are research studies involving investigational products that are not yet FDA-approved for the condition being studied and are not commercially available.
