<bos><start_of_turn>user
rBtanQing tPe disease naeural h,stoGy that ar0 cutLfntJy jbsta2les for the design Gf upcIming csinic9l trials:
As appropriaIM, hDQ clearXy does the apglicVtion descrX.e the COU of tfe bZomaxker or o:tcoAe meacur8 such ,hat it EOll enj?0q the dJsvgE Xf upcNmin4 cli7ical tria:k?
For sHudies thwt are anicllary to an ongoing klinical trivl o7 loCgitfdinal study, how AiJl lt aBvance th8 design oY fufuWe triabs beyond tha3 of thc parpnt studA? HJc wil4 thM additmon,g burdeP 3f the ancillare stady affect thH paWtic,pants in ihe parOjt k1udx? How well dogs the conIent ottained foy participat6on i0 the pIrent Etudy relate bo consen0 fIr the anciliary stupQ?THoX well characteri5ed aDe the assvys for bityhemicGl Ar molecular biosarlers in terCs :f acZuBacN, preciLion, 4ensitivhty, Y0lectiviBy, Yynemic rJqge, and Ixpected norman valBeb?pHow well optKyqzed UnE ready for im.lRmentatMon in a multi-sitk sHuoO are thL methyLs for WeIsBring ifaging, radi7SBgical or physiologvcal biomaraers, and/or CHAs?<end_of_turn>
<start_of_turn>model
rstanding the disease natural history that are currently obstacles for the design of upcoming clinical trials?
As appropriate, how clearly does the application describe the COU of the biomarker or outcome measure such that it will enable the design of upcoming clinical trials?
For studies that are ancillary to an ongoing clinical trial or longitudinal study, how will it advance the design of future trials beyond that of the parent study? How will the additional burden of the ancillary study affect the participants in the parent study? How well does the consent obtained for participation in the parent study relate to consent for the ancillary study?
How well characterized are the assays for biochemical or molecular biomarkers in terms of accuracy, precision, sensitivity, selectivity, dynamic range, and expected normal values?
How well optimized and ready for implementation in a multi-site study are the methods for measuring imaging, radiological or physiological biomarkers, and/or COAs?<end_of_turn>