How long does the average trial last? What if I am on other medication(s) from my regular doctor? What are the risks involved? What if I am harmed? Are there any tests requiring painful shots or blood samples? What should…
After a study is complete, the FDA decides whether to continue or halt the drug’s development. If it remains in development, the sponsor may build in a compassionate use extension for the study. This means that eligible patients may receive…
There are three primary phases an investigational drug has to go through before it can be approved by the FDA, and a fourth phase that an approved drug may enter. Phase I In this phase of a clinical trial, the…
The FDA is the governing agency that develops the policies and guidelines for all clinical research, regardless of manufacturer, study phase or drug type. There are also independent Institutional Review Boards (IRB) at institutions that review and approve all study-related…
There are several reasons why clinical trials are important. First, the participant may have a positive response to the study medication, and his disease or condition may improve. In addition, participants receive free laboratory and medical testing. More often than…
A clinical trial is the investigation of a new treatment for a disease. The work might be sponsored by a pharmaceutical or biotechnology company, government, university, or a private foundation. The purpose of these studies is to find out whether…
