Suggestions(1)
Exact(2)
Because measuring vomiting and nausea was obvious for the purpose of PRO development, the initial items and response categories were drafted by a cross-functional expert team that included two health outcomes/PRO researchers, one medical development lead, and one safety/regulatory lead.
However, it would be unfortunate if this debate removed the focus from the true purpose of PRO data collection; that is, to inform on the patient's perspective on the effects of treatment.
Similar(58)
For the purposes of PRO label claim analyses and given other consistencies between descriptions, we assumed the BPI-SF worst pain item was actually implemented in the Xtandi studies for both the US and EU.
So they should not be ignored for the purposes of pro-forma profits.
"That can be a bit counterproductive and I'd like to see some real clarity on the purpose of the pro-teams".
The purpose of the PRO-FIT project was to reduce cardiovascular disease (CVD) risk by promoting a healthy lifestyle in people with FH.
The purpose of measuring PROs in clinical trials alongside standard end points is to generate information to inform patients and their physicians about how treatments affect quality of life [13,14].
In order to guide those developing clinical studies to evaluate AEDs in selecting a PRO instrument for the purpose of obtaining a PRO label claim, this review sought to evaluate existing epilepsy-specific PRO instruments against FDA regulatory standards and identify any gaps in the development process that would need to be addressed prior to regulatory review.
"(Verizon) Bell Atlantic misled Massachusetts consumers and regulators with promises of advanced network deployments for the purpose of removing important pro-consumer regulation.
In both the US and Mexico, all participants' influenza diagnostic procedure was performed as part of existing studies' protocols and not specifically for the purpose of the Flu-PRO development study.
The relevance of the items should be assessed by judging whether the items are relevant for the construct to be measured (D1), for the study population (D2), and for the purpose of the HR-PRO (D3).
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com