Author Archives: janice

Clinical Studies: Going Through Phases

Phase 1 Studies evaluate the safety and metabolism of the drug in a small number (20-100) of healthy volunteers and subjects who have the disease studied. Many of these studies require overnight visits at the clinic.

Phase II studies evaluate the effectiveness of the drug and are usually carried out “blinded” with a placebo control group and utilizes several hundred patients. In these studies various doses of the drug are administered to decide the best dosage form to be used.

After the study is completed, a statistical analysis is conducted to determine the benefits and safety of the study drug. Depending on these results the sponsor can continue the process of evaluation through Phase III and apply for FDA approval or discontinue the study or compound.

On completion of these studies, if the safety and value of the drug is evident, Phase III studies are carried out in several hundred to several thousand patients, and on successful completion the pharmaceutical company can apply to the FDA for approval to market the drug.

After approval, Phase IV studies are conducted to further evaluate the drug against other similar marketed drugs and to monitor long term effectiveness and safety.

If you missed last week’s blog, you can read it here. Next week’s blog will focus on the next stage other aspects of the clinical trial process.

The text of this blog comes from the article titled “Clinical Research in the South Coast” by Paul Chervinsky, MD. It was published in the September 2009 edition of The South Coast Insider.

Clinical Studies at NEMRA

The text of this blog comes from the article titled “Clinical Research in the South Coast” by Paul Chervinsky, MD. It was published in the September 2009 edition of The South Coast Insider. Most people realize that a great deal of research takes place before a drug is approved for marketing. Few realize that residents… Continue Reading

NEMRA LAUNCHES WEBSITE REDESIGN & CONTINUES TO UNVEIL ITS NEW BRAND

North Dartmouth, MA – March 18, 2011 NEMRA, formerly known as Northeast Medical Research Associates, a leader in clinical research, today launched a completely new website designed to optimize usability and educate viewers. The new website www.NEMRA-US.com was developed in direct response to the company’s branding initiative and to speak candidly to patients and pharmaceutical… Continue Reading

NEMRA REBRANDS AND LOOKS TO THE FUTURE… how a journey of 56 years has led this research facility to a position of Experience, Leadership and Trust…

North Dartmouth, MA – February 16, 2011 Northeast Medical Research Associates (now just “NEMRA”) is proud to unveil an updated 2011 look to its corporate identity.  This new identity will obtain a well deserved new level of marketing and PR exposure for the research facility in 2011 and will firm its position as a well… Continue Reading