Welcome to Ora Recruiting! We are the ophthalmic clinical trial recruiting headquarters for Ora, Inc, the world’s leading ophthalmic CRO. We recruit patients like you to participate in eye studies. Our headquarters are in Andover, MA but we conduct studies across the United States. Our purpose at Ora Recruiting is to connect you with the ophthalmic study that best fits your unique needs. Let’s power the future of eye care together.
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1) What are the differences between study phases?
As you learn more about the process of clinical research, you may hear different studies being categorized with different phase numbers. Human testing is usually classified as Phase I, II, III, or IV. These categories can help you identify what stage of testing a particular treatment is in.
Phase 1 studies test a new drug or treatment on a small group of people in order to determine whether or not it is safe for use. In addition to helping determine the overall safety of a product, Phase 1 trials give light to potential side effects and help to identify appropriate dosing ranges to use.
During Phase 2 studies, the treatment is given to a larger group of people than in Phase 1. Generally somewhere between 100 and 300 people are given the investigational product in order to gain additional information. Safety evaluations and dosing information are gathered in order to further understand the effectiveness of the treatment.
Phase 3 studies generally include the largest amount of participants, sometimes totaling into the thousands. Safety and effectiveness of the treatment is collected and side effects are closely monitored during this Phase.
One of the final phases of testing is Phase 4 and for some treatment options this is performed after the medication has already been approved by the FDA. Risks and benefits are evaluated and additional information on the treatment is gathered.
Once approved by the FDA, additional studies on a drug or treatment may continue. Tests to improve the effectiveness or determine different formulations that may be beneficial in treatment are quite common. It is also normal to evaluate the use of a certain medication to treat more than one condition or indication.
2) How long does it take for a new treatment or device to get approved by the FDA?
The length of a clinical trial can vary greatly and more often than not, specific drugs or treatments are not able to make it through the entire approval process. About 75% of treatments move from Phase 1 to Phase 2 while only 33% of treatments move from Phase 2 to Phase 3 and 25% of Phase 3 studies make it to Phase 4. The length of time that a treatment spends in each phase is based on the clinical trial design and can range from a few months to a few years. In the case of over-the-counter medications, the approval is less extensive but the active ingredient in any medication must be approved by the FDA and move through the clinical trial process.
3) What do I need to bring?
4) Are studies safe and are there risks associated with study participation?
5) Can you do more than one study at a time?
6) Does compensation from study participating count as income?
7) What happens if you don’t finish a study or no longer want to participate?
8) How do I know if I qualify for a study?
Clinical studies vary as far as what is involved and similarly every clinical research study has different criteria to meet before you are eligible to participate. If you do not qualify for one study it does not mean that you will not qualify for all the studies that we do here at Ora. One of the members of the Ora Recruiting team will go over a series of questions with you prior to signing you up for a study to determine if you are a good candidate. If you are interested in hearing more about a study please visit our Current Studies
9) Are you guaranteed to get the study medication when you participate in a research study?
10) Are there restrictions to what you can do while participating in study?
There are normally not any restrictions to daily activities while participating in a research study. There are some instances however when certain dietary or medication restrictions exist and there are also times when lifestyle choices such as smoking or drinking alcohol are not allowed. Prior to the start of any study, a member of Ora Recruiting will review any limitations that exist and help to determine if a particular study is a good fit for you. It is important to remember that you should not stop the use of any medication or supplement prescribed to you by a doctor or specialist without reviewing it with them before doing so. Your health and safety is always our biggest concern.