Clinical Trials
Important resources to better understand Clinical Trials and to search appropriate trials in your area.
Understanding Clinical Trials
ClinicalTrials.gov
While preclinical research answers basic questions about a drug’s safety, it is not a substitute for studies of ways the drug will interact with the human body. “Clinical research” refers to studies, or trials, that are done in people. As the developers design the clinical study, they will consider what they want to accomplish for each of the different Clinical Research Phases and begin the Investigational New Drug Process (IND), a process they must go through before clinical research begins. On this page you will find information on:
  • Designing Clinical Trials
  • Clinical Research Phase Studies
  • The Investigational New Drug Process
  • Asking for FDA Assistance
  • FDA IND Review Team
  • Approval
The government-provided resource clinicaltrials.gov is an excellent source for clinical studies that may be taking place in your location and in treating specific diseases. Use the search box found on the home page, the Basic Search page, and at the top of every page of the site to begin searching for clinical studies:

Enter one or more words in the search box and then click on Search.
A list of search results will be displayed. The total number of studies found is shown at the top, along with your search terms.
The first column of the search results list, Rank, indicates the order in which the studies are listed. Studies that most closely match your search terms are listed first. The Status column shows which studies are open, or recruiting new volunteers, and which studies are closed, or not recruiting new volunteers.  
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A New Way to Treat Rheumatoid Arthritis
Biogen Drug Fails in Mid-Stage Trial
The vagus nerve is the longest of the cranial nerves, wandering through the body from the brain and through the main organs in the chest and abdomen. It has been known for some time that vagus nerve activity modulates inflammation in the body—when the nerve senses the presence of compounds that are associated with inflammation, it sends signals to the brain to release the body’s anti-inflammatory chemicals.

Researchers from New York, California, and Amsterdam recently announced the results of an innovative small study. They sought to determine whether electrically stimulating the vagus nerve can reduce inflammation in patients with rheumatoid arthritis (RA). It was the first use of this technology in humans.
Biogen Idec announced that a promising investigational medication for the treatment of relapsing-remitting or secondary progressive MS failed to meet its goals. The drug opicinumab was tested in a 418-patient SYNERGY trial. The drug was being tested to see if it would improve patients’ mobility, mental function, upper-limb use, among other signs of disability. However, the investigational drug failed to beat placebo on these and other measures.

Claiming that there was some evidence of an improved response based on the dose administered, Biogen said that it planned to continue to study the agent. “While we missed the primary endpoint, the SYNERGY study results suggest evidence of a clinical effect of opicinumab,” said Chief Medical Officer Alfred Sandrock.
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  1. Understanding Clinical Trials
    A Guide to Understanding Clinical Trials brought to you by http://www.ClinicalConnection.com
  2. Clinical Trials in Oncology
    The National Cancer Institute (NCI) supports a vast array of clinical trials designed to test new ways to treat, prevent, detect, or diagnose cancer as well as new methods to improve cancer patients' quality of life. NCI-supported clinical trials take place either intramurally at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, or extramurally at any of the hundreds of academic or private hospitals, cancer centers, or community-based medical practices located in the United States, Puerto Rico, Canada, and Europe that receive NCI funding.
  3. How Clinical Trials Happen
    The clinical trial is central to understanding whether or not a molecule can ever become a medicine. It takes a tremendous amount of collaboration and dedication to make sure our medicines meet safety and efficacy standards.