Clinical Trials

Clinical Trials News

  • Surgeons Not Good at Predicting Benefit From Knee Operations Surgeons are no better at determining which patients might benefit from operations to treat torn knee cartilage than if they just flipped a coin, a new study suggests.
  • Disparities in Access to Best Stroke Treatment Less than 10% of U.S. stroke patients get a treatment that evidence shows is most effective for ischemic stroke – and the odds are even lower for patients who are black and Hispanic, a U.S. study suggests.
 

Clinical Trials Perspective

  • Next Advances in Lung Cancer Target MET, KRAS   Although this past ASCO meeting may have lacked drama and excitement, Mark Kris was encouraged by studies on new targets and new drug constructs in lung cancer.
  • Dupilumab in the Real World: Beware Adverse Effects The experience with dupilumab, the first biologic for the treatment of atopic dermatitis, has demonstrated some marked contrasts to that seen in clinical trials.
 

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.