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Phase I Trials

Talking to a Patient about Phase 1 Clinical TrialsPhase I clinical trials are the first stage in drug testing on human participants. This initial phase in the clinical research process is where the drug is tested for the first time for safety and dosage ranges, as well as potential toxicity. Phase I research is usually operated on an inpatient basis and can last for several months or even years.

This early phase of clinical testing represents the first step in testing new therapies with qualified participants. At Avail Clinical Research, our dedicated Phase I team may be studying a potentially revolutionary treatment being developed by a biotechnology companies or a new combination of contemporary medicines.

The primary goal of our Phase I investigators is to determine whether this experimental therapy can be administered safely. They’ll monitor all the participants closely in case someone experiences some adverse effect from the administered medication. The appropriate methods of administration and dosing will also be measured carefully over the course of the study period. Please note that Phase I clinical trials are not primarily designed to test the effectiveness of a new therapy (although it can be a secondary goal in some studies).

Who Participates in Phase I Research?

Phase I clinical trials are conducted with small groups of people, generally ranging from 20 to 100 participants. A stipend is generally given during Phase I trials to compensate volunteers for their time and commitment. Commonly, healthy volunteers such as college students are enrolled for Phase I research; however, there are some rare studies in which actual patients (usually the terminally ill) will be used to test very new or toxic drugs for cancer or HIV as a last resort treatment.

What Should I Expect as a Participant?

Researchers will administer the drug being tested in single doses at the beginning of the Phase I clinical trials. Over the course of the research, doses will be increased and augmented while researchers monitor side effects, absorption rates, toxicity levels and how the drug distributes itself throughout the body. During this time, participants are sequestered for 24-hour periods where they will undergo various tests to identify how the body reacts to the dose-ranging.

(You should also check out our step-by-step guide for more information on participating in a Phase I study.)

What If You Don’t Qualify?

These early-phase clinical research studies play such a crucial role in the successful development of a new drug or treatment. This means that each Phase I trial we conduct here has a strict set of criteria governing participant eligibility. Some applicants may not meet the requirements to enroll. However, we recently upgraded our Phase I unit here at Avail, which means we will be conducting even more studies. Applicants who didn’t qualify for one trial could be eligible for an upcoming enrollment opportunity here in DeLand, FL.

With such a critical focus on Phase 1 research, our research team is looking for applicants who want to make an important contribution towards the advancement of medicine. Participants will gain access to therapies that are on the cutting-edge of medical research and have already shown promise in extensive lab testing. If this sounds like an opportunity you’d be interested in, please contact us today.

Why is Phase I Research Conducted?

Researchers will administer the drug being tested in single doses at the beginning of the Phase I clinical trials. Over the course of the research, doses will be increased and augmented while researchers monitor side effects, absorption rates, toxicity levels and how the drug distributes itself throughout the body. During this time, participants are sequestered for 24-hour periods where they will undergo various tests to identify how the body reacts to the dose-ranging.

Common Questions:

What are Clinical Research Trials?
Why Participate in a Clinical Study?
What’s the difference between a Clinical Trial and Treatment?
Additional Questions for Your Primary Physician

Learn About Clinical Studies:

Florida Clinical Research Resources
Types of Clinical Research Trials
Phase II Clinical Trials
Phase III Clinical Trials
Phase IV Clinical Trials
Clinical Trial Glossary
Clinical Trials History

Understand Your Rights:

Patient Rights
Patient Privacy
Informed Consent
NIH Patient Bill of Rights
Legal, Ethical & Safety Issues