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The majority of studies are “double-blinded.” This means that neither the study patient nor the principal investigator has knowledge of the drug that the patient has been assigned to during the study. This assures objective interaction on the part of the research staff and the study participant.

If you feel your are having problems with study medication, you should contact the research office and speak with the study coordinator who has been assigned to you during the study. If a clinician feels you may be experiencing problems with the study medication, it may need to be discontinued.

The research facility has a phone recording after hours that will instruct study patients how to contact the on call coordinator. There are back up personnel in the event that the coordinator in not able to be reached.

Most studies will reimburse study participants for time. All study related procedures such as physical exam, diagnostic laboratory studies and study medication are free to study participants.

A study patient before any participation in the study signs an informed consent. This “informed consent” will describe any known side effects and risks associated with study medication in addition to outlining any other procedures that will be required during the course of the study.

Patients involved in clinical drug trials are monitored closely and therefore evaluated frequently. In the early phases of a study, visits are more frequent perhaps once a month, however as the study progresses and the patient is doing well visits become less frequent. Laboratory studies and Electrocardiograms are usually required. Study diaries capture information on side effects, outside office visits and medication changes and need to be maintained throughout the study. Thus, study participants need to be motivated to complete the diary.

The initial visit usually is the longest. This visit may be 1 to 2 hours. It is at this visit; informed consent is reviewed with the patient along with an extensive medical history, physical exam, laboratory studies and other diagnostic tests. Subsequent visits are usually 20 to 30 minutes.

A clinical trial is the scientific evaluation of the safety and effectiveness of a new investigational medical treatment, medication or device in human volunteers. After showing considerable benefit in the laboratory, new treatments must be tested among animals and then among small groups of people for safety reasons. Carefully selected doses are then tested in large groups of volunteers to evaluate the safety and effectiveness of the treatment for a specific condition such as diabetes or high blood pressure.

Clinical trials must take place before new research treatments can be made available to the public for prescription or over-the-counter use. Many currently available medical treatments have been analyzed through clinical trials, which are carefully monitored under strict government regulations.

Clinical trials are important to ensure that individuals receive safe and effective treatments for their health conditions, from heart disease to headaches. They provide the means to develop new treatments that are as effective, more effective, or safer than treatments already on the market; they enable researchers to discover new therapeutic uses for currently available medications; and, they make it possible to develop innovative treatments for conditions that currently have no treatment.

Clinical trials are performed around the world in various settings, including doctors’ offices, hospitals, research centers, and teaching institutions such as universities. Since most trials require periodic visits to the study physician, volunteers should take the location of the facility into consideration when deciding whether or not to participate in a clinical trial.

Most clinical trials are sponsored by pharmaceutical companies, federal health agencies, medical foundations, medical centers, and universities; however, physicians may sponsor some clinical trials, particularly when the trial evaluates a currently available treatment for a condition other than for what it was previously approved.

There are risks to participating in a clinical trial. Although every effort has been made to determine the risks during pre-clinical and early clinical studies, there may be side effects and other health risks that are as of yet unknown. Side effects differ from one person to another, and there is no way to predict how the treatment will affect any given individual. Some of the risks are that participants may not receive active treatment for their condition and/or the study treatment may not be effective. Trials sometimes require washout periods when subjects have to go off all active treatments for a period of time. The reasonably foreseeable risks of a study are listed in the informed consent form.

Volunteers who participate in clinical trials help to further advance medical science, which may help others in the future. While there are no guarantees that participants will benefit from the research treatment they receive, some may find that the study medication relieves their condition more effectively and/or with fewer side effects than their previous treatment plan. Clinical trials sponsored by pharmaceutical companies often provide free study medication and study-related care. In addition, financial compensation for time and travel expenses may be provided to study participants in some clinical trials.

A placebo is an inactive substance that may be given to a percentage of the study participants in a clinical trial to assist in evaluating the effects of the active study treatment

Informed consent is the process by which a potential study participant is provided with information about the study and treatment before deciding whether or not to participate in the trial. It includes an explanation of what is involved in the trial, the duration of the study, the frequency and length of the required visits, as well as the known risks and benefits associated with the study treatment.

Participation in a clinical trial is completely voluntary. All questions about the study should be answered to the patient’s satisfaction before an informed consent form (ICF) is signed. Patients have the right to refuse participation or to withdraw their consent at any time during the study without penalty.

The wishes and best interest of the patient are considered at all times and, throughout the trial, participants will be provided with any new information that may affect their decision to continue their participation in the study. In addition, the study physician may withdraw a patient at any time, without the patient’s consent, if it becomes evident that the treatment is not in the patient’s best interest.

In the interest of safety, the participant must fully inform the study physician about past and current medical conditions, illnesses and medications; follow the prescribed treatment plan; and, attend the scheduled visits. Other, study-specific responsibilities will be explained by study personnel.

Clinical trials are governed by clearly defined ethical and legal codes. In 1981, regulations of the Food and Drug Administration made it a requirement that all federally regulated clinical trials be reviewed and approved by an Institutional Review Board (IRB) before and during the course of the trial. An IRB is a committee of volunteers including experts and lay people such as doctors, scientists, clergy, and other community members. Their primary goals are to protect the public, to evaluate whether the potential benefits of study participation outweigh the risks, and to ensure that patients are not coerced into participating in a clinical trial.

Study plans and the progress of clinical trials are reviewed periodically by the IRB as well as by the study sponsor and the investigator. The FDA and other federal agencies such as the National Institute of Health oversee the Institutional Review Boards.

Ongoing changes to clinical trial regulations and the review process help to ensure that the rights and welfare of study participants are protected more thoroughly than in past years.

Patients may call the IRB with questions about their rights as a research participant. The name and telephone number of the IRB overseeing the clinical trial is included in the informed consent form.

Patient confidentiality is maintained as much as possible during and after a clinical trial. Outside of the research team, a participant’s name may not be disclosed without the permission of the participant unless required by law. Generally, the sponsor, F.D.A., and the IRB have access to the study patient’s medical records. To ensure confidentiality, volunteers are assigned a patient number once they are enrolled in a trial and are identified by this number and their initials for the duration of the study.

Patient confidentiality is maintained in the same manner when the results of a clinical trial are reported to government agencies and in scientific meetings and medical journals.

There are many ways to find out about clinical trials, including advertising, listings on the internet, mailings, word of mouth, health fairs, and physician referrals. Individuals looking for clinical trials for a specific condition should discuss the available options with their physician.

Once a patient contacts a research site, the caller will usually have a brief telephone interview to determine if he or she would likely be a good candidate for the study. A screening visit may then be scheduled for a potential candidate to discuss the trial in more detail and to further screen the candidate for qualification, possibly resulting in study enrollment.

Patients may not be enrolled into a clinical trial without their knowledge and written consent. American citizens are now protected under strict federal regulations preventing the unauthorized use of investigational treatments.

In the case of minors, a parent or legal guardian may provide consent for a child to participate in a clinical trial.

Investigational treatments may, however, be administered to patients in life threatening situations who are unable to provide informed consent only if no other treatment options are available, and if there are no authorized persons or family members to sign the consent form on the patient’s behalf.

There is no cost for joining a clinical trial, and study medication as well as study-related tests and procedures are usually provided at no charge to study participants. It is important to ask the research staff to explain exactly what charges, if any, may be the responsibility of the study participant. Tests and procedures that are part of a patient’s routine health care may or may not be covered by the patient’s health insurance plan.

• Why is the clinical trial being conducted?
• What type of treatment is being studied?
• What are the known side effects of the study treatment?
• How long is the study?
• How often and when will I be expected to come in for visits?
• How long will each visit last?
• How often, when, and how does the study treatment have to be taken?
• When should I call the doctor?
• Who do I contact in case of an emergency?
• Can I continue my current medications?
• What medications do I need to avoid?
• Should I avoid alcohol, specific foods or other agents?
• What procedures are required during the study?
• What effects should I expect from these procedures?
• What other treatment options are available to me, and what advantages or disadvantages could I expect from them?
• Will I be responsible for the cost of any of the visits, medications, or procedures performed during the trial?
• Will my own physician be notified about my participation in the trial?
• How will my study participation affect my daily life?

The situation in which the study participant, the investigator, or both do not know which study treatment the participant is receiving to ensure unbiased evaluation of the study treatment.

The process by which an investigational treatment is tested in human volunteers.

The American government’s agency responsible for protecting the public’s health by regulating the review, research, and approval of investigational treatments. Informed Consent - The process by which a potential study participant is provided with information about the study and treatment before deciding whether or not to participate in the trial.

A board, committee, or other group formally designated by an institution to review biomedical research involving human subjects. In the U.S., an IRB reviews the protocol, approves initiation of research, and periodically reviews the conduct of research.

A medication or treatment that has not been approved for use by the public.

An inactive substance that may be given to a percentage of the study participants in a clinical trial to assist in evaluating the effects of the active study treatment.

A document that states the rationale, objectives, statistical design, and methodology of the clinical trial and the conditions for performance and management.

The process by which study participants are randomly assigned to receive a particular study medication, dosage, or placebo.

A symptom resulting from a treatment that was not the intended purpose of the treatment.