Cervical Dysplasia — Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia [Part II]
Citation(s)
Nene BM, Hiremath PS, Kane S, Fayette JM, Shastri SS, Sankaranarayanan R Effectiveness, safety, and acceptability of cryotherapy by midwives for cervical intraepithelial neoplasia in Maharashtra, India. Int J Gynaecol Obstet. 2008 Dec;103(3):232-6. doi: 10.1016/j.ijgo.2008.07.016. Epub 2008 Sep 24.
Quentin W, Adu-Sarkodie Y, Terris-Prestholt F, Legood R, Opoku BK, Mayaud P Costs of cervical cancer screening and treatment using visual inspection with acetic acid (VIA) and cryotherapy in Ghana: the importance of scale. Trop Med Int Health. 2011 Mar;16(3):379-89. doi: 10.1111/j.1365-3156.2010.02722.x. Epub 2011 Jan 9.
Sauvaget C, Muwonge R, Sankaranarayanan R Meta-analysis of the effectiveness of cryotherapy in the treatment of cervical intraepithelial neoplasia. Int J Gynaecol Obstet. 2013 Mar;120(3):218-23. doi: 10.1016/j.ijgo.2012.10.014. Epub 2012 Dec 22.
Sawaya GF, Grimes DA New technologies in cervical cytology screening: a word of caution. Obstet Gynecol. 1999 Aug;94(2):307-10.
Thomas G Are we making progress in curing advanced cervical cancer? J Clin Oncol. 2011 May 1;29(13):1654-6. doi: 10.1200/JCO.2010.34.1966. Epub 2011 Mar 28.
van der Graaf Y, Klinkhamer PJ, Vooijs GP Effect of population screening for cancer of the uterine cervix in Nijmegen, The Netherlands. Prev Med. 1986 Nov;15(6):582-90.
Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia
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.
