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Solutions in the Round -- DATA = CLINICAL; (WUSS)

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Introduction

From the WUSS abstract for this topic

This session will discuss recent trends in the pharmaceutical industry. CDISC, ADaM, investment in Real World Evidence will be potential topics in this “all things clinical” discussion. Solutions in the Round (SITR) is a roundtable format section where attendees discuss approaches and solutions to a programming problem or SAS topic. Users from different perspectives and all experience levels are encouraged to participate.

Discussion at WUSS

Facilitators:

Richann Watson (RW), SAS

- ADaM


Carey Smoak (CS), Looking Glass Analytics

- parent of CDISC for medical devices


  • Definitions ( Controlled terminology ):
 CDISC	==  Clinical Data Integration Standards Corporation
 SDTM	==  Submitted Data Tabulation Model 
 ADaM	==  Analysis Data Model
 CDASH   ==  Corrrelation for Data Acqusitions, 

Standardization, Harmonization

 TAUG    ==  Therapeutic Area User Guide


  • Clinical Trials Data need traceability & reproducibility
 FDA reproduce efficacy & safety endpoints
 -  If match, then review results
 -  If not, return to sponsor


  • What issues with CDISC?
 - Pinnacle 21 tool mismatches with variable labels
 -- use SDRG, ADRG (reviewer guides)
 -- tool doesn't always match FDA rules 
 -- community vs enterprise ($$)
 


Q: Is there a way to save results outside of community folder?

 RW:  Submit suggestion to Pinnacle 21 group
 -  filenames are long and very similar for SDTM, ADaM, etc.


CS: What problems with storing data that does not fit

 CDASH v2.0 -- better mapping for SDTM than v1.0
 == Collection, case reports
 -> saves a LOT of explanations in SDRG (can say "used CDASH")


Q: Defines mappings

 RW:  use defines
 -  create them EARLY!
 -  Helps you along the way
 CS:  "Keep define in mind" early in study for ADaM


Q: When working on ADaM datasets, just run ADaM alone for Pinnacle


 RW:  Need to submit STDM with ADaM for Pinnacle 21
 - include DM, EX, DS, AE tables


CS: Medical group

 - add CDRH to CDISC group
 - Worked with a presenter from CDRH to show CDISC solutions for lack of standardized sponsor submissions


Q: Use PhUSE for SDRG and ADRG

 FDA:  Strongly recommend PhUSE templates
 RW: includes ammendments, can explain 2 waterfall analyses for oncology studies
 CS:  Have to *fix* isssues, not just report them. 
 -  Explain AE after close of study (last disposition date)
 -  FDA has tools beyond Pinnacle 21
   -- find hidden data
   -- "data fitness"
   -- "data quality"
 TLF
   "Fit" data needs little or no data programming in TLF 
 CRF --> STDM --> ADaM


RW: ADaM == "1 PROC away" from results


Q: TLF

 RW:  not analyses
 - Listings from ADaM or STDM
   --  More complex from ADaM
   --  Else, from STDM
     ---AD AE
   Safety populations from AD AE
   "Screen failures"
 RW:  Traceability 
   -> STDM or ADaM for listings
   -> original data / standard data
   -> can bring STDM variables to ADaM for easier listings 
   -> avoid listings from merges (FDA cannot easily reproduce)
   -> Do not create ADaM solely for listings (e.g. medical history)
   -> use STDM image domain


Q: Data that does not fit standard domains?

 Implentmentation Guide 
 May need "type C" letter / meeting (communication)  (pre-NDA)
 -  Have this type of data, plan to use custom domain: is this acceptable?
 CS: Engage FDA early, engage FDA often 


 Custom Study Standardization Plan (early in plan, phase 1 .. 3)
 "Rel-Rec" (?)


Upcoming Presentations by Facilitators

CS:

 - Underutilized aspects of CDISC

RW:

 - Avoiding ADaM sinkholes

Further Discussion -- Open to All

Please join the conversation! Also, if you were one of the live participants, please feel free to correct any mistakes or omissions from our original discussion.