Edwards TJ, Dickinson AJ, Natale S, Gosling J, McGrath JS A prospective analysis of the diagnostic yield resulting from the attendance of 4020 patients at a protocol-driven haematuria clinic. BJU Int. 2006 Feb;97(2):301-5; discussion 305. doi: 10.1111/j.1464-410X.2006.05976.x.
Kelly JD, Fawcett DP, Goldberg LC Assessment and management of non-visible haematuria in primary care. BMJ. 2009 Jan 16;338:a3021. doi: 10.1136/bmj.a3021. No abstract available.
Lotan Y, Elias K, Svatek RS, Bagrodia A, Nuss G, Moran B, Sagalowsky AI Bladder cancer screening in a high risk asymptomatic population using a point of care urine based protein tumor marker. J Urol. 2009 Jul;182(1):52-7; discussion 58. doi: 10.1016/j.juro.2009.02.142. Epub 2009 May 17.
Lyratzopoulos G, Abel GA, McPhail S, Neal RD, Rubin GP Gender inequalities in the promptness of diagnosis of bladder and renal cancer after symptomatic presentation: evidence from secondary analysis of an English primary care audit survey. BMJ Open. 2013 Jun 24;3(6):e002861. doi: 10.1136/bmjopen-2013-002861.
A Prospective Observational Study to Determine the Negative Predictive Value of UroMark to Rule Out the Presence of Bladder Cancer in Patients With Haematuria.
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.
