Clinical research trials
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 institutional review board (IRB) and designed to help ensure the safety of every volunteer.
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 a different trial. Phase 1 trials are conducted with healthy subjects as well as subjects with a specific condition or disease.
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.
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 compensation and the lab work to be done. 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 enroled 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 examination 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 qualify or not 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.Interested in volunteering?