Clinical Trials

Clinical Trials News

 

Clinical Trials Perspective

  • CANVAS: Straight Talk Needed on Amputation Risk Can a meta-analysis of two different studies or data from observational studies overcome the clinical concern about the clear-cut amputation risk with canagliflozin seen in the CANVAS trial?
  • CME: Can You Trust What You Read? A review of accredited educational programs on hypogonadism turned up some common themes, including those not supported by the evidence.
 

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.