Respiratory Syncytial Virus Infections — Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy
Citation(s)
Bjornson C, Chan P, Li A, Paes B, Lanctôt KL, Mitchell I Palivizumab prophylaxis for respiratory syncytial virus in infants with cystic fibrosis: is there a need? Eur J Clin Microbiol Infect Dis. 2018 Mar 19. doi: 10.1007/s10096-018-3225-7. [Epub ahead o
Paes B, Mitchell I, Li A, Harimoto T, Lanctôt KL Respiratory-related hospitalizations following prophylaxis in the Canadian registry for palivizumab (2005-2012) compared to other international registries. Clin Dev Immunol. 2013;2013:917068. doi: 10.1155/
Paes B, Mitchell I, Li A, Lanctôt KL Respiratory hospitalizations and respiratory syncytial virus prophylaxis in special populations. Eur J Pediatr. 2012 May;171(5):833-41. doi: 10.1007/s00431-011-1654-8. Epub 2011 Dec 28. Erratum in: Eur J Pediatr. 2012
Paes B, Mitchell I, Li A, Lanctôt KL; CARESS Investigators A comparative study of respiratory syncytial virus (RSV) prophylaxis in premature infants within the Canadian Registry of Palivizumab (CARESS). Eur J Clin Microbiol Infect Dis. 2012 Oct;31(10):27
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.
