Clinical Trials

Clinical Trials News

  • A Novel Treatment Approach for PML Progressive multifocal leukoencephalopathy, caused by the JC virus, has no known treatment. A new study offers a novel approach using T-cell infusions from the more treatable BK virus.
  • AAO 2018 Drug Pipeline for Macular Degeneration in Focus at AAO Updates from phase 3 trials of VEGF inhibitors for neovascular age-related macular degeneration, and a novel genetic treatment, will be highlighted at the American Academy of Ophthalmology meeting.
 

Clinical Trials Perspective

  • Oral Semaglutide a 'PIONEER' in the Treatment of T2D   Dr Martin Haluzik discusses the results of the PIONEER 1 trial, which evaluated the efficacy and safety of oral semaglutide, the first GLP-1 receptor agonist in tablet formulation.
  • 'WIN' With Women in Diabetes Research and Clinical Practice   Dr Darleen Sandoval discusses the Women's Interprofessional Network of the American Diabetes Association and the group's goals, aimed at supporting women in diabetes research and clinical practice.
 

Journals

 

Glossary

  • Compassionate Use: A way to provide experimental, not-yet-approved treatment to patients who are critically ill and are not responsive to other treatments. Physicians may need to get case-by-case approval from the FDA for "compassionate use" of a drug or therapy.
  • Inclusion/Exclusion Criteria: These determine whether an individual may take part in a clinical trial. Criteria are based on age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
  • Investigational New Drug Application (IND): After preclinical testing, a company files an IND with the FDA to begin to test the drug in humans. The IND becomes effective if the FDA does not disapprove it within 30 days. The IND describes prior experiments, the new study protocol, the composition and manufacture of the investigational drug, and any toxic effects found in the animal studies.
  • Orphan Drugs: Medications for diseases and conditions that occur rarely. Pharmaceutical companies have little financial incentive to develop drugs for these diseases. Orphan drug status, conferred by the FDA, gives a manufacturer specific financial incentives to develop such medications.
  • Phase 3: A drug that shows positive results in small groups of patients may be studied in a larger phase 3 trial to confirm its efficacy and note adverse events that occur with long-term use. Hundreds or thousands of patients may be involved.
 
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