Clinical trials are studies involving drugs or devices managed or sponsored by government agencies (such as National
              Institutes of Health), educational institutions, not-for-profit organizations or commercial groups that develop, produce
              and/or evaluate effectiveness of new drug or device therapies.

•  How are clinical trials conducted?

              Clinical trials conducted are strictly conducted under the regulatory  oversight of bodies such as Institutional    
              Sponsoring Agency, Review Boards (IRB), Data Safety Monitoring Board (DSMB) and/or Food and Drug
              Food And Drug Administration (FDA).
              There are several processes in place designed to protect the potential participants that include:
                    1. Informed Consent: The process of providing subjects with detailed information about important
                        information specific to the clinical trial and about the experimental drug or device that may be involved in it.

                    2. Sponsoring Agency: Ensures through rigorous protocol and periodic review that potential participants are
                        adequately protected.

                    3. Institutional Review Board (IRB): IRB is responsible for instituting strict oversight of the clinical trial with goal
                        of protecting the rights and well-being of people who participate in research studies.
                        Most clinical research studies cannot begin without a review board’s approval. Board members generally
                        include health care personnel such as doctors, nurses, and pharmacists. The Board also includes other
                        members of the scientific community, non-scientists such as clergy or social workers, and community
                        members.
                        Once the clinical research study begins, the Board is responsible for periodically reviewing the approved
                        study to assure that the rights and welfare of research participants continue to be appropriately protected.

• What are the phases of Clinical Trials?

                
                1. Phase I Trial: These are studies to assess how a drug should be administered, how often and what is
                   the dosage.Such trials focus on the safety of the drug agent.

                2. Phase II Trial: Provide preliminary information on how a therapy works and regarding its safety and
                    benefits.

                3. Phase III Trial: The aim is to compare the new therapy, procedure or device with current standard.

                4. Phase IV Trial: Includes ongoing evaluation of the drug or device after it has been approved by FDA and
                    has become available for general use.
                   

•   What is a Clinical Trial Protocol? 
  

                Clinical Trial Protocols are a set of sepcific and stringent set of guidelines that must be followed  throughout the
                course of study. These guidelines include:  
                       Study Design
                       Eligibility criteria: who can participate in sudy
                       Treatment and medical tests to be followed during the course of study
                       Specific study related questions that trial may be seeking to answer

•    Who can participate in a clinical trial?      

                Participation in a clinical trial is defined by eligibility criteria. The particpants must meet these criteria in order to
                be eligible to particpate in the trial. Having appropriate eligibility criteria assures that the results answer the questions
                study was desinged for and also determines who is likely to benefit from the researched drug, procedure or device.

• What are some of the ongoing clinical trials at CNMG?
  

              Some of the trials that are currently ongoing or may begin soon include:

• Diabetes mellitus
• Kidney Disease and Diabetes mellitus
• Home hemodialysis
• Anemia Treatments
• Protein in Urine
• Hepatitis B                     

             To find out more information on clinical trials or to find out if you can participate in a clinical trial please speak
             with your  physician or email to research@cnmgonline.com