Serving Idaho families since 1961...
Search Saltzer Medical Group
Serving Idaho families since 1961...
Search Saltzer Medical Group

Archive for April, 2009

What are the phases of a clinical trial?

Wednesday, April 22nd, 2009

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.

Clinical Research Defined part 2

Monday, April 13th, 2009

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.

Clinical Research Defined part 1

Friday, April 10th, 2009

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.

Saltzer Quick Care

Monday, April 6th, 2009

Saltzer Quick Care

When Tomorrow is Not Soon Enough — Saltzer can help

Urgent Care Services

Two convenient locations

215 E. Hawaii Ave, Nampa
(Next to St. Alphonsus, Nampa)

And

9850 W. St. Luke’s Drive, Nampa

(Behind Nampa Costco)

Open: 8:00 AM – 8:00 PM, Seven Days a week

*It is not necessary to be established as a Saltzer patient to receive urgent care services at Saltzer Quick Care. We have wonderful providers that can provide urgent care services no matter where, or if, you receive primary medical care.

Specialist's Section
Search Saltzer Medical Group
© 2007 Saltzer Medical Group. All rights reserved.
Saltzermed.com does not provide medical advice, diagnosis, or treatment.