FAQ ABOUT CLINICAL RESEARCH TRIALS

It is important to have all of your questions answered when choosing to participate in a clinical trial. The following frequently asked questions will provide you with detailed information about clinical trials. In addition, it is often helpful to talk to your health care provider, the Investigator of the study, or the Study Coordinator about deciding to participate in a study. If you have any further questions or concerns you may also call Jean Brown Research directly at (801) 261-2000.

For more information on clinical studies, visit the US Government site at http://clinicaltrials.gov/ct2/info/understand

WHAT IS THE STORY OF JEAN BROWN RESEARCH?
Jean Brown, RN, MOB, began her career in research as a Study Coordinator in the early 1980's. In 1986, she started her own research company, specializing in analgesic trials. Because of her experience and commitment to "extraordinary service" Jean is nationally recognized for her work in the research of analgesic agents as well as other areas. Employees at Jean Brown Research demonstrate the same commitment to extraordinary service and a belief that our research is an important contribution to the medical field.

WHAT IS CLINICAL RESEARCH?
Clinical research is the testing of an investigational drug or device in humans with a company-approved protocol, written in accordance with government regulations and company procedures. Investigational drugs include:
A drug that has not been approved for marketing;
An approved drug being studied in a non-approved indication or new route of administration, new strength or new formulation;
A drug marketed by one company being considered by another company for in-license or acquisition and undergoing clinical study by the company;
A drug which contains known and established ingredients but has not been marketed by the company;
An approved drug that is to be studied in a specific target population, such as children or geriatric patients, for which the drug is not approved.

Before a new treatment is tried with humans it is carefully studied in the laboratory. The results from this laboratory research point out the new methods most likely to succeed, and, as much as possible, show how to use them safely and effectively. This early research cannot predict, however, exactly how a new treatment will work with human patients. With any new treatment, there may be risks as well as possible benefits. There may also be some risks that are not yet known. Clinical trials help to find if a promising new treatment is safe and effective for patients. During a trial, a great deal of information is obtained about a new treatment, its risks, and how well it may or may not work.

WHAT ARE THE PHASES OF CLINICAL RESEARCH?
Phase I trials involve the initial exposure of a small number of humans, who are healthy volunteers, to investigational drugs. The sole objective is safety. They are designed to determine the metabolism (bioavailability) and pharmacologic actions of the drug. One objective is to find the preferred route of administration.

Phase II studies help to determine how safe and effective a drug is, common short-term side effects, pharmacokinetic and pharmacodynamic values (obtained through blood samples) in patients with the indication for the drug, and identify the dose range for Phase III studies. Phase II studies involve a larger group of patients usually 100-200 patients total.

PHASE III trials provide additional safety and efficacy measurements. They are initiated when an acceptable risk profile in relation to efficacy exists. There is collection of data on a large patient population and there is an attempt to mimic the expected condition of use. The indication and dosage are confirmed.
Phase III studies are large and multicentered: 10-30 sites per protocol and include 500-5,000 patients total.

PHASE IV studies are post-marketing studies and include exposure of the drug to the "real" population.

Different formulations, dosages, duration of treatment, drug interactions, and other drug comparisons are studied. Phase IV studies may be required as a provision of the Food and Drug Administration (FDA) for product approval. The trials may include new age groups, races and other types of patients. This phase includes the detection and definition of previously unknown or inadequately quantified adverse events and related risk factors. There is a broad range of patients from 5,000-20,000 total.

THE ROLE OF JEAN BROWN RESEARCH IN CLINICAL TRIALS?
Jean Brown Research serves as a consultant in clinical research, responsible for gathering accurate, timely, and complete data through the completion of successful clinical research trials. The company has been in business since 1986 and has grown into a recognized leader in the field of analgesic pharmaceutical research. Jean Brown Research has conducted analgesic clinical trials in the following areas:

Post Operative Dental Extractions
Post-Operative Orthopedic Procedures
Post-Operative Abdominal Hysterectomies
Post-Operative Cesarean Sections
Post-Operative Bunionectomies
Osteoarthritis/Rheumatoid Arthritis
Dysmenorrhea
Malignancy Pain
Headaches
Sore Throat Pain
Acute elbow pain

Although Jean Brown Research has specialized in analgesic research, successful trials have been, and continue to be, conducted in multiple areas. The following are examples of non-analgesic trials that have been conducted:

Diabetes
Heartburn
Preventative Anti-Coagulant Therapy
Viral Infections
Vaccination

Jean Brown Research interacts closely with the Principal Investigator (PI) and assists with a variety of functions throughout the clinical research process, but the primary responsibility for the trial remains with the PI at all times. The following list outlines the duties Jean Brown Research performs as part of study management, under the direction of the PI:

Review the project and choose a management team
Consider study feasibility and potential sites
Select investigators from a network of experienced clinical investigators in academia and private practice
Prepare budget proposals and submit to the Sponsor
Oversee all financial arrangements for the study
Initiate and prepare all documents for IRB submission
Arrange pre-study and initiation meetings
Select experienced members of the JBR research team to assist the PI with patient enrollment, data collection and case report form collection
Ensure accountability of all study drug
Ensure compliance with Standard Operating Procedures, FDA guidelines, and Good Clinical Practice guidelines at all times
Conduct studies according to specific protocols
Enroll appropriate patients in a timely manner
Provide accurate, reliable, and consistent data
Collaborate with the Sponsor for successful progress during the study until completion of the clinical trial

WHY SHOULD I PARTICIPATE IN A CLINICAL TRIAL?
Patients take part in clinical trials for many reasons. Usually, they hope for benefits for themselves. They may hope for a cure of disease, a longer time to live, financial compensation, or a way to decrease or eliminate pain. Or, they may want to contribute to a research effort that may help others. The patients in a clinical trial are among the first to receive new research treatments before they are widely available. How a treatment will work for a patient in a trial can't be known ahead of time. Even standard treatments, although effective in many patients, do not carry sure benefits for everyone. Patients should decide whether or not to participate in a study only after they understand both the potential risks and benefits. The patients who take part in clinical trial procedures that do prove to be better treatments have the first chance to benefit from them. All patients in clinical trials are carefully monitored both during and following the conclusion of the trial.

WHO CAN PARTICIPATE IN A CLINCIAL TRIAL?
All clinical trials have guidelines about who can get into the program. Guidelines are based on such factors as age, type of disease, medical history, and current medical condition. Before you join a clinical trial, you must qualify for the study. Some research studies seek volunteers with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers. Healthy volunteers participate in Phase I trials, vaccine studies, and trials on research on preventive care for children or adults.
The factors that allow you to participate in a clinical trial are called inclusion criteria and the factors that keep you from participating are called exclusion criteria. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

WHAT HAPPENS DURING A STUDY?
The clinical trial process depends on the kind of trial you participate in. A Study Coordinator and the Principle Investigator will assist you throughout your study participation. They will check your health at the beginning of the trial, give you specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch with you after the study.

Some clinical trials involve more tests and doctor visits than you would normally have for your illness or condition. For all types of trials, you will work with a research team of nurses and medical professionals. Your participation will be most successful if you follow the protocol carefully and stay in contact with the research staff.

ARE THERE RISKS OR SIDE EFFECTS IN CLINICAL TRIALS?
Yes. The treatments used in clinical trials can cause side effects and other health risks, depending on the type of treatment and the patient's condition. Side effects vary from patient to patient. Because clinical trials are research into new areas of treatment, the risks involved are not always known ahead of time, though efforts have been made to find out what they might be. For this reason, trials can carry unknown dangers and side effects, as well as hoped-for benefits. Patients need to know what is involved in a study, what side effects may be expected and, as much as possible, what unknowns or uncertainties they may be facing. This information will be covered thoroughly during the informed consent process prior to participating in a study.

WHAT REGULATIONS EXIST TO MONITOR CLINICAL RESEARCH TRIALS?
FOOD AND DRUG ADMINISTRATION (FDA)
The role of the FDA includes the following:
Acts as the gatekeeper to protect the public
Ensures the quality and integrity of the data obtained from clinical testing so that approval decisions are informed and responsible
Protects the rights and, to the degree possible, the welfare of clinical subjects
Implements an approval process that determines when and if patients are given access to new therapies
Sets the regulatory guidelines for all clinical research (both drugs and devices)
Participates with the International Conference on Harmonization in working for standardization of drug and device research worldwide

FDA regulations encompass the following organizations and people:
Clinical Investigators
Sponsors
Contract Research Organizations
Institutional Review Boards

(Refer to the Sponsor Visits and Regulatory Audits section for additional information on the processes used by the FDA to audit clinical research studies.)

GOOD CLINICAL PRACTICE GUIDELINES
Good Clinical Practice (GCP) is the term coined by the pharmaceutical and medical device industries to encompass the federal regulations and industry-accepted standards that govern clinical trials on humans. These regulations and standards apply to the conduct of the studies, record keeping, informed consent of subjects, collection of scientific data, and submission of information needed in order for the FDA to make an evaluation to approve or disapprove the product.

INSTITUTIONAL REVIEW BOARDS
An Institutional Review Board (IRB) is any board, committee or other group formally designated by an institution to review, approve the initiation of, and conduct periodic review of research involving human subjects. IRBs are responsible for the following:
Assure that the risks to clinical subjects are minimized
Ensure that subjects are adequately informed about the trial and its implications for their treatment
Order modifications of a trial protocol, when necessary, to ensure safety
Ensure risks are reasonable in relation to the anticipated benefits and the importance of the knowledge to be gained
Ensure subject selection is equitable and that no classes of patients are discriminated against
Ensure informed consent is obtained
Make sure there is a provision for the monitoring of safety in the research plan
Ensure there are adequate provisions for privacy and confidentiality for subjects and the data collected

WHAT IS A PROTOCOL?
All clinical trials are based on a set of rules called a protocol. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

WHAT IS INFORMED CONSENT?
Informed Consent is a freely given agreement on the part of a competent person in full possession of all available, pertinent information to participate as a subject in a clinical research trial.

Consent may only be given by the study subject, or if the subject is a minor or otherwise incapable of acting on his or her own behalf, the subject’s parent or legally acceptable representative may give consent. Informed Consent is documented by means of a written, signed, and dated Informed Consent form. Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and Institutional Review Board (IRB) regulations require that Informed Consent be obtained before any subject may participate in clinical research trials.

WHAT IS A PRINICPLE INVESTIGATOR?
Principal Investigators (PIs) are usually physicians or oral surgeons, although regulatory authorities do not require this. The regulations that govern clinical research set forth by the FDA and ICH define PIs as people qualified by education, training, and experience to assume responsibility for the proper conduct of a trial. In addition to ethical responsibilities, the PI is the leader of the study team. He/she bears final responsibility for the quality control of study procedures and the integrity and scientific merit of study findings.

WHAT IS A STUDY COORDINATOR?
The experienced Study Coordinator is a valuable source of knowledge and guidance for patients. As the person at the site who devotes a great deal of time to the planning and conduct of research projects, the Study Coordinator develops a high level of expertise. The Study Coordinator is the “expert” of the protocol aside from the Principle Investigator. They will assist you throughout the study during the consenting process, taking the study medication, performing evaluations, and answering any questions you may have. The Study Coordinator is often a nurse, but not always.

WHO SPONSOR’S CLINICAL TRIALS?
Clinical trials are sponsored by government agencies: such as the National Institutes of Health (NIH); pharmaceutical companies; individual physician- investigators; health care institutions such as health maintenance organizations (HMOs); and organizations that develop medical devices or equipment. Trials can take place in a variety of locations, such as hospitals, surgical centers, universities, or doctors'/dentists’ offices.

WHAT IS A PLACEBO?
A placebo is an inactive substance (pill, liquid, or powder) that has no treatment value. It may be referred to as a “blank” or “sugar pill.” In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In many studies, the participants will receive a placebo instead of an active drug or treatment.

WHAT IS AN ADVERSE EVENT?
Adverse event (AE), as used in the context of clinical research, means any untoward medical occurrence in a patient administered a pharmaceutical product which does not necessarily have to have causal relationship with this treatment. Adverse events can be: a symptom (e.g., a headache), a finding during a physical exam (e.g., elevated blood pressure), a syndrome or disease (e.g., “flu syndrome” or meningitis), or an abnormal laboratory value.

WHAT SHOULD I KNOW BEFORE PARTICIPATING IN A RESEARCH STUDY?
You should know as much as possible about the research study. It is important for you to feel very comfortable asking questions and the staff should answer them in a way you can understand. We have provided some questions that may assist you in deciding whether or not to participate in a clinical research trial.

How should I prepare for the meeting with the study coordinator or doctor?
Plan ahead and write down the questions you want to ask.
Ask a friend or relative to come with you for support and to hear the responses to your questions.
Review the website information regarding the study.

What questions should I ask?
Why is this research being done?
What is the purpose of the study?
Who is sponsoring the study?
Who has reviewed and approved this study?
Why does the research team think the treatment, drug, or medical device will work?
What kinds of therapies, procedures, and/or tests will I have during the trial?
Will they hurt? If so, for how long?
How will the tests in the study compare to tests I would have outside the study?
How long will the study last?
How often will I have to go to the study site?
Will I be able to take my regular medications during the trial?
What medications, procedures, or treatments must I avoid while in the study?
What are my responsibilities during the study?
Will I have to be in the hospital during the study?
Will the study researchers work with my doctor while I am in the study?
Can anyone find out that I am participating in a study?
Can I talk to other people in the study?
Will I be able to find out the results of the trial?
Questions about risks and benefits include:
How do the possible risks and benefits of the study compare with approved treatments for me?
What are the possible immediate and long-term side effects?
Will I have to pay anything to participate in the study?
What are the charges likely to be?
Is my insurance likely to cover those expenses?

SHOULD I CONTINUE WORKING WITH MY HEALTH CARE PROVIDER IF I PARTICIPATE?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but not extended or complete primary health care. In addition, by having your health care provider work with the research team, you can ensure that your other medications or treatments will not conflict with the clinical trial protocol.

CAN I STOP PARTICIPATING IN A STUDY ONCE I HAVE STARTED?
Yes. You can leave a clinical trial at any time. It is termed “withdrawing your consent.” If you plan to stop participating, let the Study Coordinator or Principle Investigator know that you would like to withdraw your consent and why you are leaving the study.

WILL I GET PAID FOR PARTICIPATING IN A RESEARCH STUDY?
Most clinical trials will pay you for your time and travel while participating in the study. Jean Brown Research may also pay for your surgery, medical exams, and medical procedures as well, depending on the type of study you join. If your participation includes staying at the Research Center or another facility for any length of time, you may also receive meals or snacks.