What you need to know

1What are Clinical Trials?

Clinical trials are research studies designed to answer specific questions about safety and effectiveness of investigational drugs, medical devices, procedures or behavioral changes. In most cases clinical trials compare a new medical approach to an existing one or to a placebo.

A placebo is an inactive substance that looks the same as the active substance. Clinical trials can also be conducted on medications that are already approved by the FDA to determine if they may be useful for another condition, or to determine the safety or effectiveness of long-term use.

2What is Clinical Research?
Clinical research is intended to advance medical and/or scientific knowledge. This research is not designed to determine the effectiveness of a treatment.
3What are the different types of Clinical Trials?

Smoking Cessation Trials test new methods or treatments for helping smokers quit smoking.

Treatment Trials test new treatments or new combinations of drugs for smoking cessation or harm reduction.

Research Trials are intended to answer a research or medical question.

Prevention Trials look for better ways to prevent a specific disease in people who have never had that disease or to prevent a disease from reoccurring.

Diagnostic Trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening Trials test the best way to detect certain diseases or health conditions.

Quality of Life Trials explore ways to improve comfort and the quality of life for individuals.

4What are the different phases of Clinical Trials

Phase I Trials test a new drug or treatment using a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify common side effects.

Phase II Trials test a study drug or treatment using a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

Phase III Trials test a study drug or treatment using a large group of people (1,000-3,000) to confirm effectiveness, monitor side effects, compare it to commonly used treatments, and to collect additional information that will allow the drug or treatment to be used safely.

Phase IV Trials test a marketed study drug or treatment to discover additional information including the drug’s risks, benefits, and optimal use.

5What should I expect as a research participant?

When you call RRC to inquire about participating in a clinical study, a member of the RRC study team will discuss study specifics and ask you questions about your medical history. If you meet the criteria for participation in the study, depending on the specific study, we will either ask you to come to our office for a screening visit or to complete a virtual screening visit using our eResearch mobile application.

During the screening visit, a study team member will talk to you about the study. You will be given information about why the study is being conducted, the procedures involved in your participation and any risks and benefits. You will have an opportunity to ask any questions so that you can make an informed decision about whether or not you would like to participate in the study.

If you decide that you would like to participate, you will be asked to sign a consent form outlining all the information that you discussed with the study staff. After consent is obtained you will be scheduled for the additional study sessions.

6What are the benefits to participating in a Clinical Trial?

Gain access to new research treatments before they are widely available.

Help others by contributing to medical research.

7What are the risks to participating in a Clinical Trial?

Side effects will differ from study to study, you will be informed of the expected side effects in the consent form.

The protocol may require more time than a non-investigational treatment, including multiple trips to the study site and completion of questionnaires at home.

8How long with the Clinical Trials last?

Some clinical trials require only one visit to the research center and other trials may last weeks or months and require multiple visits to the center. These visits could last a few minutes or a few hours.

The time involved in the trial be discussed at the screening session during the informed consent process. This information will also be documented in the informed consent form.

9Will I receive compensation for my participation?

Yes. The amount of compensation you will receive for your participation in the clinical trial is determined by the amount of time you will be required to dedicate to the trial and to the level of discomfort that you may experience. If you withdrawal from the trial early, your payment will be prorated based on the amount of the trial you completed.

Payment information, including the amount and schedule of payment(s), as well as any possible costs to you will be discussed at the screening session during the informed consent process. This information will also be documented in the informed consent form.

10Do I need to ask my regular doctor before I can participate in a research study?

No. However, you should tell your usual doctor that you are thinking of participating in this research study. Your doctor may wish to contact the study doctor (with your permission) to request additional information.

11What is informed consent?

The informed consent process provides you with the information required to ensure you make an informed decision about participation in the clinical research study. This process will:

• Help you to understand the information

• Give you an opportunity to ask questions and to consider whether to participate

• Obtain your voluntary agreement to participate

• Continue to provide information as the clinical research study progresses

Before participating, we will take you through a written Informed Consent Form (ICF) that outlines the important information to consider before joining the study. The study doctor will go through this document with you and answer any questions you may have. This document provides details of the study, such as study expectations, duration, and what you will need to do. All known possible risks and potential benefits are also explained in the ICF. After you have read and discussed all of the information about the study, you can decide whether or not to sign the consent form. This consent form is not a contract and you are always free to leave the study at any time and for any reason, with no penalty to you. Additionally, during your participation, the study doctor will let you know in a timely manner of any information that may change your mind about participating.

Why should I participate?

Participants may gain access to new research treatments before they are widely available.

Additionally, participants are compensated for their time and receive study-related products and medications at no cost. You may be among the first to benefit if the approach being studied is found to be helpful.