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.
Join a study. See the impact.
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?
When you come into the office for your study visit, please bring photo identification. Other than that, it’s up to you! Some study visits are lengthy so you can feel free to bring a book or some other form of entertainment or any snacks or drinks that you would like to have while you are in the office.
4) Are studies safe and are there risks associated with study participation?
It is important to understand that there may be risks associated with clinical research. Any and all risks pertaining to study participation are explained in a document called the Informed Consent. This document will be reviewed with you by a member of our clinical team and signed in office prior to the start of any study related procedures. It is important to remember that some risks with clinical research are comparable to those related to daily living or routine health care. Most research studies do have some risks involved and a staff member or doctor can help you to understand the degree and the likelihood of any adverse events happening during a study. These can range from minor complications to side effects that may require medical attention. Know that your safety is always at the forefront of everything we do. Before deciding to join a study, carefully weigh out any risks involved and please feel free to call the Ora Recruiting team toll free at 1-866-393-3767. We would be more than happy to address and answer any questions that you may have!
5) Can you do more than one study at a time?
When you choose to participate in one research study, you become ineligible to sign up for other research studies at the same time whether it be with Ora or any other company conducting studies. This is due to the fact that clinical trials are designed to evaluate one specific treatment and participation in more than one at a time would make identifying the risks and benefits of each treatment difficult. Usually there is a designated amount of time to wait between studies know as a wash-out period. This wash-out period varies from study to study and is often based on what sort of treatment or medication is being used during a particular study. This information can be given to you by our recruiting specialists who will be able to identify what studies you are a good candidate for.
6) Does compensation from study participating count as income?
When you come in for a study and receive compensation this does count as income. It is advised that you declare payments made during a study to the IRS and there are certain regulations that require Ora by law to provide information to the IRS about payments to study participants. For more information, please visit this
link.
7) What happens if you don’t finish a study or no longer want to participate?
Informed consent (see FAQ 4) is NOT a contract. You can leave the study at any time you choose, for any reason and there is no penalty involved with leaving a study early. You always have the choice to choose what treatment you are receiving whether it is during a clinical trial or part of your standard care. During the study, the investigator or study doctor may also decide that it is best for you to discontinue participation. This is based on their judgement because your safety is always our biggest concern.
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?
Some clinical research studies involve something called a placebo, which contains no active medication and has no health benefits. This is used as a control to determine the effectiveness of a specific treatment that is being tested. The chances of you receiving a placebo vary from study to study and this information can be given to you by anyone over the phone from Ora Recruiting or once you go into the clinic for your first appointment.
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.
