Eye On ICON.

Phase 1 Clinical Research

Before medications and devices can be approved, they must first be tested. Testing must be done for new medications/devices, new uses for approved medications/devices, or for approval to use products already in use in other countries.

The approval process starts with testing in a laboratory or with animals to determine potential toxicity. Then testing progresses with research trials with human volunteers. Clinical research trials are designed to determine a safe dosage range and identify any potential side effects of a new treatment. The approval process for human volunteers takes place in Phase I-IV clinical research trials. Typically the Phase 1 research stage lasts for one to two years. It is estimated that 30% of products in Phase 1 research will successfully advance to Phase II.

The Food and Drug Administration (FDA) is responsible for the approval of new medications and devices, as well as new uses for products that have been approved. Testing and FDA approval is mandatory before any pharmaceutical product can go into production to help patients. Research trials are conducted under strict regulations and protocols.

The FDA is responsible for the protection of participants of clinical research trials as well as providing reliable information for subjects who are interested in participating. Each trial has a detailed research plan, or protocol, that is carefully reviewed by an independent ethics board and designed to help ensure the safety of every volunteer.

Participation

Phase 1 trials primarily determine the safety of a treatment in humans and whether it is well tolerated. While most Phase I clinical trials require healthy adults, each study is different. For instance, some trials may be testing for a particular age group, gender, a specific medical condition or those taking a particular medication. It all depends on what the researchers are investigating.

If you don’t qualify for one trial, you may fit the criteria for the next. Phase 1 trials are conducted with healthy subjects as well as subjects with a specific condition or disease.

The Food and Drug Administration (FDA) is responsible for the approval of new medications and devices, as well as new uses for products that have been approved. Testing and FDA approval is mandatory before any pharmaceutical product can go into production to help patients. Research trials are conducted under strict regulations and protocols.

The FDA is responsible for the protection of participants of clinical research trials as well as providing reliable information for subjects who are interested in participating. Each trial has a detailed research plan, or protocol, that is carefully reviewed by an independent ethics board and designed to help ensure the safety of every volunteer.

As a general rule, in order to qualify to participate in studies with ICON:

  • You must be 18 years or older
  • Have the required BMI for the particular study
  • No usage of any illegal drugs
  • Legal (and current) government ID and Social Security number.

To find out if you meet the criteria for a trial, you can contact our recruiters. Or, you can view the study description online and then schedule a screening appointment. You can also be added to our database by filling out our online questionnaire.

At your screening visit, you will be provided with information about the study in a document called an informed consent form (ICF). The ICF describes the study in detail including the purpose of the study, length of the study, possible risks/benefits of your involvement, procedures (such as vital signs, ECG, etc.) the lab work to be done, compensation, etc. The potential risks depend upon the treatment being studied. All this information will be reviewed with you by a Registered Nurse or Doctor. If a subject is eligible, he/she must sign the ICF to be enrolled in the study and before any study procedures can be performed.

If you agree to participate, staff will review your medical history, medications and conduct the screening procedures outlined in the ICF. One of our doctors will give you a comprehensive physical to assess your health status. Once all results are obtained, your information will be compared against the study criteria. You will then be informed if you qualified or did not pass based on the criteria for that particular study. Study participation is monitored and carefully assessed starting with the signing of the ICF, during the trial and after it is completed.

Research Terminology

ICON Early Phase Services conducts a wide variety of Phase I studies. Some of the terms can be described in multiple ways and this can be confusing. Below is a list of terms for your reference.

The FDA is responsible for the protection of participants of clinical research trials as well as providing reliable information for subjects who are interested in participating. Each trial has a detailed research plan, or protocol, that is carefully reviewed by an independent ethics board and designed to help ensure the safety of every volunteer.

  • Alzheimer’s research studies
  • allergy studies: seasonal allergies
  • asthma studies
  • bunionectomy studies - removal of a bunion
  • compensation: research study compensation, research volunteer, study participant, stipend
  • depression studies
  • dermatological studies: atopic dermatitis, eczema
  • diabetic studies: type 1 diabetic, type 2 diabetic clinical research, type 2 diabetic on 2 medications, insulin dependend diabetic, diet controlled diabetic, type 2 diabetic on metformin, type 2 diabetic research trial, type 2 diabetic with high blood pressure
  • gastrointestinal studies: inflammatory bowel (IBS) disease, constipation
  • healthy studies:  similar to other terms such as healthy clinical trial, healthy men and women, healthy patient study, healthy research study, healthy research subjects, healthy research trial, healthy volunteers
  • high blood pressure studies: hypertension
  • high cholesterol studies: hyperlipidemia 
  • inflammatory disease studies: arthritis, Celiac disease, Crohn’s disease, fibromyalgia, psoriasis 
  • men’s studies: prostate, erectile dysfunction
  • obese and overweight studies
  • pain studies: acute pain, chronic pain
  • peripheral arterial disease (PAD) studies
  • renal studies: kidney disease
  • research studies: similar to other terms such as investigational research, research study, clinical research study, clinical trial, research trial, research site
  • respiratory infection studies
  • senior study: for subjects age 65+
  • sickle cell disease studies
  • vaccine studies: flu, influenza, infectious diseases
  • women’s studies: hot flash, oral contraception, menopause, osteoporosis, postmenopausal, childbearing, non-childbearing, birth control

Term Definitions

Clinical research uses terminology from a variety of resources including the medical field, clinical research, science, government regulation, etc. The use of these terms varies according to the type of study being described. Below is a list of some terms that you may come across in reading about study descriptions.

Abbreviation
Full Description
AE
Adverse Event
AMPM
Ambulatory Blood Pressure Monitoring
ARM
Any treatment group in a randomized research study
Anaphylaxis
A serious, life-threatening allergic reaction
BP
Blood Pressure
BMI
Body Mass Index
Baseline
Information gathered at the beginning of the study
Biologic
Virus, toxin, vaccine, etc. for the treatment or cure of diseases
Blinding
Process in which one or more parties in a research study is unaware of the treatment assignments
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