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.

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions: Saltzer Clinical Research participates in Phase II – IV trials. The trial protocols are designed by the sponsoring pharmaceutical company, then distributed to sites like ours to recruit subjects for them. The trials are closely monitored to ensure that the physicians are following the protocol exactly as written and make sure the data we report is accurate. Physicians (Principal Investigators) and study coordinators are required to report all adverse events that occur while a person is on a study whether or not it is related to the drug or not.

In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80), for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety in the population of patients it is intended to treat.

In Phase III trials, the experimental study drug or treatment is given to an even larger groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use or to compare two FDA approved drugs to each other. After a drug is FDA approved, it is still studied in Phase IV trials.

The role of the Clinical Research Coordinator in Clinical Trials

Clinical Research Coordinators (CRCs) are members of a team working in the health field of medical research and development. They arrange the research study site, recruit, screen and enroll clinical study participants; arrange follow-up visits; maintain and dispense study drugs and other supplies; and complete and ensure the accuracy of the data submitted to the study sponsor. A CRC works under the immediate direction and supervision of a physician/Principal Investigator whose research activities are conducted under FDA and Good Clinical Practice (GCP) Guidelines. Most CRCs have some medical training prior to working as a CRC. After two years in the position a CRC has an opportunity to test to be credentialed as a Certified Clinical Research Coordinator (CCRC) which is the internationally recognize professional credential in the industry.

WORK ENVIRONMENT

Most Clinical Research Coordinators work in hospitals, physician offices, biomedical research organizations and institutions, specialty disease centers and pharmaceutical and medical device companies. Clinical research encompasses many different healthcare settings and specialties. Saltzer Clinical Research currently has 4 full time CRCs conducting trials in the following therapeutic areas – Cataracts, Glaucoma, Atrial Fibrillation, Diabetes, Osteo Arthritis, Rheumatoid arthritis and Pediatric vaccines. For more information visit our clinical research page.

If you are involved in a clinical research trial, there are certain key people who will help facilitate your involvement in the trial. In this short series we will look at some of those positions essential to a successful clinical research trial.

Did you know that many physicians at Saltzer Medical Group are investigators in a clinical trial?

An investigator is the physician responsible for the conduct of the clinical trial at a trial site. If a study is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the Principal Investigator. Guidelines mandate that a sponsor shall select only investigators qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, and evidence of these requirements through a current curriculum vitae. There are currently 10 physicians, in various therapuetic areas at Saltzer Medical Group, that are principal investigators for clinical trials. These trials are sponsored by various pharmaceutical companies and offer exposure to new and promising treatments right here in Nampa, Idaho. for more information go to our clinical research page.

Consider looking into the possibility of qualifying for a Clinical Trial at Saltzer Clinical Research. If you qualify you receive all study related physician visits, lab tests, medications and supplies at no cost AND we compensate you for time and travel expenses.

We are currently seeking volunteers for trials in the following theraputic areas
Type 2 Diabetes
Osteoarthritis
Atrial Fibrillation
Chronic Hand Eczema
Glaucoma
Pediatric Vaccines

For more information please call 208-288-4952

The pharmaceutical pipeline is full of new and promising therapies. The number of trials needed for these new products is growing. Medical research projects are more ambitious today than ever before. The large pharmaceutical companies that sponsor these trials are turning to smaller sites all over rural America like Nampa.

Saltzer Medical Group in Nampa, Idaho employs a large clinical research staff and is offering participation in several trials in various therapeutic areas. Participants on a clinical research study receive study medication and doctor visits at no cost as well as lab tests, x-rays and EKGs. For anyone who is struggling with the cost of medical care in today’s economy, this is an excellent alternative to treatment. For more information on currently enrolling trials click here.

What is Informed Consent?

Informed consent is a document that you are asked to read and sign that explains:

Who can be in a study?

Each study has different requirements for participants such as age, gender, or medical condition. The research team will look at your medical history and study requirements to find out if you are eligible. Most studies involve more tests and visits than you would normally have for an illness or condition. There is no cost to participate, in fact you get paid at each study visit.

Why participate?

Saltzer is one of the few sites in Idaho paticipating in studies. The research department is staffed with experienced trial coordinators and physicians. Join a trial today and you will not only be helping researcher find new treatments, but will also learn new information about your condition and receive study-related medicines and exams at no cost.

For more information on current research trials, please click here.

A clinical trial is a research study that involved people who volunteer to receive investigational treatments under the supervision of the physician conducting the trial for the pharmaceutical company. It is through these trials that the investigational medications are tested for safety and effectiveness in the population of patients the medicine is intended to treat.

Other times studies are done to compare one drug to another or to test its long term effectiveness. It is important to know that once the medication has been sent to the physician for study, it has already been through several preliminary studies. Prior to agreeing to participate in any trial you are asked to sign an informed consent form. The FDA reviews all clinical trial activity and independent review boards exist to make sure your rights are protected and that you are not exposed to unnecessary risks. A volunteer has the right to leave the study at any time and for any reason.

For more information on current research trials, please click here.