The Institutional Review Board (IRB) is a group of health care professionals that must review and approve the details of a clinical trial before it begins. The primary responsibility of the IRB is to review all study-related activity and to protect the safety and rights of study participants and to make sure no one is exposed to unnecessary risks.
The Informed Consent Form is designed to give the potential participant, or their legal representative, easy-to-understand information regarding all aspects of a specific clinical trial. It is designed to provide all the information needed to help a person decide it they want to participate in the trial. Adequate time is allowed to ask questions and to make sure the potential participant feels comfortable with and agrees to the terms of the clinical trial. No study related procedures will be performed until the Informed Consent Form is signed by the participant. Each participant is given a copy of the Informed Consent Form.
People volunteer for trials for a number of reasons but most often it is to help in the advancement of science or to treat a disease for which a treatment does not currently exist. A volunteer is usually assigned a specific study group. Sometimes volunteers in one study group will receive an investigational treatment and others receive a placebo or a treatment already available. A placebo is an inactive product used as a basis of comparison for the results of the study drug. Whether a placebo or investigational drug is used, the level of medical attention and care received by study participants at Saltzer Medical Group is the same. A volunteer has the right to leave the study at any time and for any reason.
Any person with the condition being studied who meets all of the study specific criteria can volunteer to participate in a trial. Every trial has very specific requirements such as age, sex, weight, and a specific diagnosed medical condition. The doctor overseeing the clinical trial reviews each potential participant’s medical history to determine if that person is eligible. Known side effects and and potential participant’s medical history to determine if that person is eligible. Known side effects and potential risks, as well as all study procedures, are thoroughly explained to potential participants by the physician prior to participation. In addition, Saltzer Medical Group’s Clinical Research department always maintains strict confidentiality regarding information about individuals who participate in clinical trials. In addition Saltzer physicians provide a stipend to all patients at each visit to cover time and travel.
A recent survey done by Center Watch, a clinical Trial listing company, indicates that the majority of people that take part in a clinical research trial felt that it was a positive experience. Most felt like they benefited from the experience. The goal of the survey was to better the clinical trial experience. Over 80% rated their experience as very good to excellent and 77% stated they would definitely participate in another clinical trial. Several physicians at Saltzer Medical Group are involved in clinical trials and are always recruiting for volunteers. If you or someone you know has diabetes, or high blood pressure, you may qualify for one of the ongoing trials. If interested call Marisue Smith/Director of Clinical Research at 208-463-3126.
The pharmaceutical pipeline is full of new promising therapies. The number of trials needed for these new products is growing. The large pharmaceutical companies that sponsor these trials are turning to smaller sites all over rural America. Saltzer Medical Group is proud to be one of many sites in the Treasure Valley helping to bring new drugs to market by participating in several clinical trials. Saltzer has a fully staffed researh department and over 15 ongoing trials involving over 200 participants including infants, children, teens and adults. Trial currently enrolling are: Pediatric vaccines, Type 2 diabetes, and Hypertension. To find out if you qualify check out saltzermed.com and click on research under the specialties tab.
CONSIDER JOINING SALTZER CLINICAL RESEARCH IN BEING PART OF THE CURE
If you are interested in helping the clinical research team at Saltzer Clinical Research investigate new medications, please contact the Director of Clinical Research, Marisue Smith at (208) 463 3126 or email marisuesmith@saltzermed.com.
She will be happy to provide you with information about current and upcoming clinical trials that might be right for your participation. Should you choose to participate in a clinical trial, please understand that our mutual commitment to the completion of the trial is critical. The very success of clinical trials hinges on completion. We look forward to hearing from you for a mutually beneficial experience.
Primary Investigator – The physician with the primary responsibility for the design and conduct of a research project or clinical trial
Clinical Trial – A carefully designed study of the effects of medication, medical treatment, or a medical device on a group of volunteer subjects.
Subject – An individual who volunteers to participate in a clinical trial.
Placebo – A chemically neutral substance given under the guise of medicine for its psychologically suggestive effect; used in a controlled clinical trial to determine whether improvement and side effects may reflect imagination or anticipation rather than the actual power of the drug.
Double-blind – When neither the investigator nor the subject knows which medication the subject will be receiving.
Inclusion/Exclusion Criteria – The specific protocol requirements such as age, medical history weight, diagnosis, and laboratory values that determine if a subject can be included in a clinical trial.
Any person with the condition being studied who meets all of the study specific criteria can volunteer to participate in a trial. Every trial has very specific requirements such as age, sex, weight and a specific diagnosed medical condition. The doctor overseeing the clinical trial reviews each potential participant’s medical history to determine if that person is eligible. Known side effects and potential risks, as well as all study procedures, will be thoroughly explained to potential participants by either the Principal Investigator or the study coordinator prior to participation. In addition, Saltzer Clinical Research always maintains strict confidentiality regarding information about individuals who participate in clinical trials.
When can a medication be tested in an outpatient clinical trial setting like Saltzer medical Group?
When a pharmaceutical company has a new medication they would like to test in a clinical trial, a request is submitted by the sponsoring company to the U.S. Food and Drug Administration (FDA). Before the FDA grants permission to conduct a clinical trial, they will verify that the pharmaceutical company has already done extensive laboratory research regarding the new medication. Only then will the FDA allow a newly proposed medication to be tested in humans. All of the trials currently being conducted at Saltzer are later phase trials in which the medication has been heavily studied prior to being studied in the market it is intended to treat.
