Tuberculosis — Innovative Approach in Tuberculosis Care in Armenia
Citation(s)
Newell JN, Baral SC, Pande SB, Bam DS, Malla P Family-member DOTS and community DOTS for tuberculosis control in Nepal: cluster-randomised controlled trial. Lancet. 2006 Mar 18;367(9514):903-9.
Raza S, Sarfaraz M, Ahmad M Practice of family and non-family based directly observed treatment for tuberculosis in Pakistan: A retrospective cohort study. The Health 2012; 3(2): 39-44
Truzyan N, Harutyunyan T, Koshkakaryan M, Petrosyan V Household TB Infection Control Pilot Project: Counseling for TB Patients and Their Family Members. American University of Armenia School of Public Health, Center for Health Services Research and Development, Yerevan, Armenia, 2013
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.