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Frequently Asked Questions

Understanding Clinical Trials

Sound Medical Research (SMR) was developed to provide our community with additional health care options. We offer patients the opportunity to take a more active role in their own health care. We grant them access to cutting-edge treatments before they are made available to the general public. In addition, along with our patients, we help advance medicine and give hope to those suffering from disease.

Deciding to join a clinical trial is a significant personal decision. It is often helpful to talk with your doctor, family members, or friends before choosing to participate in a trial. To assist potential participants in this decision process, SMR has provided general information about clinical trials in the FAQ list and glossary below.


Who can participate in a clinical trial?
Some trials require healthy participants, while others need volunteers who suffer from a particular illness or condition. However, each and every participant must be found eligible before volunteering for a clinical trial. A research study’s objectives and regulations determine who may qualify. Reliable results are produced only when participants meet certain criteria. These specifications are based on factors such as gender, age, the type or stage of an illness, additional medical conditions, and previous treatment history. Inclusion and exclusion criteria are used to discern eligible participants and to ensure their safety.

What happens during a clinical trial?
The SMR team leads participants through the entire process, which varies according to the type of trial being conducted. The staff is comprised of research coordinators, physicians, and medical assistants. At the beginning of the trial, the SMR team checks each participant’s health and gives detailed instructions for taking part in the trial. During the study, they dedicate themselves to carefully monitoring the condition of the participants. They continue to keep in contact with the participants after the trial is complete. SMR has found that participation in clinical trials is most effective when protocol is fulfilled and there is frequent contact between the team and participants. Some trials require very little commitment or time. Others call for more doctor visits and tests than is usually necessary for treating an illness.

What should I consider before deciding to participate in a trial?
Potential participants should be well-informed about the clinical trial and shouldn’t hesitate to ask questions of the SMR team. Volunteers may find answers to some of the following questions in the informed consent document. The remainder may be discussed with the research team.
• What is the main purpose of this study?
• Who can participate in the study? What are the eligibility requirements?
• What makes researchers believe this new drug may be effective? Have other studies previously been done on this drug?
• What kinds of tests, drugs, or treatments are involved?
• How does the experimental treatment get paid for?
• Will I need to be hospitalized?
• How does my current condition and treatment compare with the possible benefits, risks, or side effects of the clinical trial?
• Will my daily life be affected by this trial?
• How much of my time will the trial take?
• Who will provide my medical care?
• Will any travel expenses be reimbursed to me?
• How will I know whether or not the drug is working?
• Will I be able to find out the results of the study?
• Will I receive any long-term follow-up care?

How should I prepare before meeting with the doctor or research coordinator?
• Invite a family member or friend to accompany you and participate in the conversation.
• Write down a list of your questions to bring with you.
• Consider bringing a tape recorder. You may want to listen to the discussion again later in the comfort of your home.

How is my safety protected?
Clinical research is often federally funded, and trials fall under the same legal and ethical standards that govern medical practice. Study participants are protected by established safeguards and by strict adherence to the trial’s protocol. During clinical trials, researchers are expected to share the study’s results with government agencies, medical journals, and at scientific meetings. The names of participants are not used in these reports, nor are they disclosed.

In addition, by federal regulation, every clinical trial must be endorsed and monitored by an Institutional Review Board (IRB) to verify the integrity of the study and make sure the risks are minimal. The IRB is a private committee of doctors, statisticians, and community advocates who ensure the welfare and rights of participants are protected.

Can I leave a clinical trial after it has started?
Yes, at any point in the process participants may leave a clinical trial. When withdrawing, participants should inform the SMR team why they have elected to leave the study.

Who comes up with the idea for a clinical trial?
Researchers typically propose ideas for SMR trials. Their experimental treatments are advanced to clinical trials only after they have been thoroughly tested in the laboratory and in animal studies. Through the course of a trial, the benefits, risks, and potential success of an experimental treatment are discovered.

Who pays for clinical trials?
Clinical trials may be funded or sponsored by federal agencies, pharmaceutical companies, medical institutions, foundations, physicians, or voluntary groups. Consequently, the trials may occur in community clinics, doctors’ offices, hospitals, or universities. SMR trials are usually conducted in a private health care center.

What types of clinical trials are performed?
Treatment trials examine experimental therapy, new combinations of drugs, or recently developed techniques in surgery and radiation treatment.

Prevention trials pinpoint methods of disease prevention in patients who are in remission or who have never suffered from the disease. These procedures may involve vitamins, minerals, drugs, vaccines, and even lifestyle changes.

Diagnostic trials search for more effective procedures and tests used for diagnosing a specific illness or disease.

Screening trials study the optimal method for detecting particular health conditions or diseases.

Quality of Life/Supportive Care trials investigate how to increase the comfort of and improve the quality of life for patients suffering from a chronic disease.

What are the different phases of clinical trials?
Phase I trials involve testing a new drug or treatment on small populations (typically 20 to 80 healthy participants and/or patients). The researchers evaluate the experimental drug’s potency, metabolism, and potential side effects.

In Phase II trials, the drug is further tested for safety and efficacy in a slightly larger population of patients (100 to 300) who are afflicted with the disease for which the drug was developed.

Phase III trials require the drug be given to groups of roughly 1,000 to 3,000 afflicted patients. These studies test the drug in comparison with the standard therapy currently in use, verify that its benefits outweigh the risks, and provide information for the package insert and physician labeling.

Once the drug has been approved by the FDA, Phase IV trials are conducted to compare it to a competitor, identify optimal use, and further study any adverse reactions.

Glossary

Clinical trial
There are many technical and detailed definitions of the term clinical trial. Simply put, it is a scientific and medical research study designed to find a better way to treat or prevent a disease.

Control group
A control is used as a standard of comparison for evaluating the results of an experiment. In a research study, one group of volunteers may receive an experimental treatment or drug. In contrast, the control group may receive a standard therapy for the illness, a placebo, or no treatment at all.

Informed consent
After doctors and research coordinators provide complete, objective information regarding a clinical trial, patients may choose to verify their willingness to participate through informed consent. The SMR team will supply an informed consent document explaining the study’s purpose, procedures, potential risks, benefits, and the volunteer’s rights and responsibilities. Patients then decide whether or not to sign the document. Informed consent is not a binding contract; participants may excuse themselves from the study at any time.

Placebo
A placebo is a harmless, inactive substance that resembles the drug being tested in a clinical trial. Placebos are used as a control to evaluate the potency of the experimental treatment. In well-designed studies, volunteers in the control group will unknowingly take a placebo rather than an active therapy or drug.

Protocol
A protocol is a detailed plan stating the study design, objectives, and system of methods to be used in a clinical trial. This plan is developed in order to find answers to specific research questions while protecting the health of the participants. A protocol outlines the duration of the study, who may participate, and what they can expect by way of tests, procedures, and medications. While following a protocol, trial participants meet with SMR staff regularly to ensure their treatment’s effectiveness and safety.

Side effects
Any symptoms or effects caused by the experimental treatment are called side effects. Some examples of possible negative or adverse reactions are: nausea, headache, skin irritation, hair loss, or other physical difficulties. Experimental drugs are evaluated for short- and long-term side effects.

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