Endpoints in clinical trials: What do XXXX consider important? A survey of the Ovarian Cancer National Alliance.

@entity1 @entity137 @entity5 @entity1017 @entity2359
OBJECTIVE: In order to understand the @entity1 's perspective in regards to meaningful surrogate clinical trial endpoints and the impact of treatment-related @entity137 , and quality of life, we surveyed @entity1 with gynecological @entity5 to ascertain their preferences. METHODS: A 28-question anonymous online survey was posted on the OCNA website (www.ovariancancer.org). Survey questions included demographic factors, @entity5 data, and @entity1 ' preference regarding side effects and therapy endpoints. Data was analyzed for frequency and percentage of each response. Student t-test, Fisher's exact test and Wilcoxon rank sums were preformed. RESULTS: There were 1413 survey responses. @entity1 reported that for a new agent to be meaningful, the minimum extension of progression-free survival (PFS) and overall survival (OS) should be five or more months, 77% and 85% of the time, respectively. Most subjects (55%, n=612) were interested in an agent that would keep @entity5 growth relatively static without change in OS. Addressing the impact of adverse aspects from a hypothetical new agent as a function of response, there was significant migration (p<0.0001) to acceptance of greater @entity137 and cost under the scenario of a 5-6months @entity1017 , despite three-fold higher @entity2359 , as compared to a PFS gain of 3-4months/no @entity1017 without @entity137 . Response patterns weren't altered by recurrence status. CONCLUSIONS: Herein, we show that magnitude of outcome is a desired effect, even given the prospect of significant @entity137 and cost. However, these preferences appear to differ between those with primary and recurrent disease.
