NCT01031641 - Clinical Trial References

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.

Citation(s)

Clark MA, Armstrong G, Bonacore L
Measuring sexual orientation and gender expression among middle-aged and older women in a cancer screening study. J Cancer Educ. 2005 Summer;20(2):108-12.
Diefenbach MA, Weinstein ND, O'Reilly J
Scales for assessing perceptions of health hazard susceptibility. Health Educ Res. 1993 Jun;8(2):181-92.
Friedenreich CM, Courneya KS, Bryant HE
Relation between intensity of physical activity and breast cancer risk reduction. Med Sci Sports Exerc. 2001 Sep;33(9):1538-45.

Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing

Details for clinical trial NCT01031641

Clinical trial NCT01031641 - References