New Features of SASIPH-Clinicaloo Software

Transcription

1 New Features f SASIPH-Clinical Sftware Brian Fredric, SAS Institute Abstract SASIPH-Clinical(ID sftware is the first prduct in the SASIPH series t be delivered by the SAS Institute. It is a prductivity tl the management, analysis, reprting, and internal/external review f clinical trials data, and has been develped and enhanced based n the needs f the pharmaceutical industry and regulatry agencies. This paper gives an verview f the latest new features implemented in SASIPH-Clinical sftware t satisfy current requirements by users. The paper als discusses the future directin fr the sftware and annunces the Institute's new release f the sftware, SASIPH-Clinical 2.0 Intrductin SASIPH-Clinical sftware is a fully integrated cmpnent f the SAS<Rl System, and is the first majr prduct in the SASIPH series. It is a prductivity tl fr clinical trials data management, analysis, reprting, and internal/external review and has been develped and enhanced based n the needs f the pharmaceutical industry and regulatry agencies. The sftware is already being used as significant cmpnents f CANDAICAPLA submissins t regulatry agencies. The industry is becming mre aware f the requirements fr successful electrnic submissins, and has identified internal and external review f data, reprts, graphics, images and any ther supprt infrmatin fr a submissin. The current sftware and the next exciting release bth facilate this very imprtant prcess fr the industry. Desi&n Gals The main design gals f SASIPH-Clinical sftware are t prvide pharmaceutical industry with a sftware envirnment fr the access, analysis, presentatin, and internal/external review f clinical trials data. The sftware is designed t be intuitive, friendly, interactive and highly functinal giving users access t clinical trials data, and pwerful analysis, reprting and review tls withut having t wrry abut the underlying prgramming requ"ired t achieve these tasks. Functinality SASIPH-Clinical sftware prvides extensive functinality fr the management, explratin, analysis, reprting, and internal/external review f clinical trials data. SASIPH-Clinical sftware functinality is delivered via a user-friendly "pint and click" interface with icns that enable yu t access the varius functioilal cmpnents f the sftware. These functinal cmpnents can be summarized as fllws: Patient Grups This cmpnent allws users t select patient subset/chrt data frm the available studies. These selectins can be based n criteria that the user defines interactively, n selected patient IDs, and even selected variables available. \ \, 916

2 The user can decide whether the selected patients data be frzen in a "snapsht" f changing underlying SAS datasets and databases, r whether the patient grup be built each time frm live views f the data. Patient Grups and instructins t build these grups can be saved in a Library fr future access. The underlying data fr any clinical trial is managed by a Resurce Manager, and access is prvided by a View Generatr and a Patient Grup Generatr. These 3 cmpnents f the sftware ensure that the crrect infrmatin is delivered whenever it is required. Brwse Patients Lking at data and reviewing it in different frmats is ne f the key cmpnents f a CANDAICAPLA system. SASIPH-Clinical sftware allws yu t lk at patient data in a tabular frmat, recrd by recrd frmat, image frmat, and even in a data entry screen r custmized screen frmat. Being able t "Drill dwn" frm data n the screen t actual images f the CRF and custmized screen prvides reviewers with a mechanism fr checking and validating actual data. This functinal cmpnent als allws yu t subset the patient grup further and presents just thse variables that are interest t yu. It frms ne f the mst pwerful tls available t pharmacetical prfessinals investigating and reviewing clinical trials data tday. Study Overviews The "meta data" maintained by the Resurce Manager and describing a study can be access very easily via this functinal cmpnent and prvides excellent summary infrmatin abut available studies. Tables This functinal cmpnent prvides access t table building tls fr i-way, 2-way, N-way, ad-hc tables, and well as tls fr building ad-hc listings and reprts, including Adverse Event reprts. All styles f tables and reprts are access via a friendly "fill in the gaps" style screen and prvide extensive access t selectable lists f variables, parameters, ptins, etc that cntrl the layut. Drilldwn frm frequency data t actual data recrds, images, and custmized screens is als pssible frm the Tables facilities and prvides a unique review tl fr accessing summarized data. Analyses Analysis f data is key t the success f clinical trials and tends t vary accrding t the level f the prffesinal wrking with the data. Clinical Bistatisticians need a different suite f tls cmpared t a Clinician wh may need nly summary infrmatin. This functinal cmpnent is cntrlled by a security mechanism allwing access t nly thse users wh shuld get access t high pwered statistically methds, while restricting ther users t limited sumary methds such as descriptive statistics and calculatin f percent change. Shuld a user find the SASIPH-Clinical sftware envirnment t restrictive fr analysis purpses, then access t the Display Manager and even SASI ASSIST can be granted via the security mechanism. Graphs This cmpnent make full use f the graphics pwer f the SAS System and prvides a cmprehensive list f graphic tls fr users t access. Like mst cmpnents, a "pint and click" friendly interface is prvided t facilate easy creatin f the required graphic using all the clinical data that the Resurce Manager is making available transparently t a user. Library A key tl fr any CANDAICAPLA sftware, the Library cmpnent prvides a streage and retrieval system fr Patient Grups, Prgrams, Output, Graphics, and any ntes made during the cmpilatin f a CANDAICAPLA submissin. This very pwerful tls allws yu t step back in time and recreate anything that has been prduced within the SASIPH-Clinical sftware envirnment. This prcess is vital fr the internal and external review prcess, especially when queries are being made n items in a submissin by either the spnsr r the regulatry agency. 917

3 Explre The explre cmpnent is anther functinal cmpnent that is cntrlled by a security mechanism as it prvides users access t the very pwerful SAS prduct fr data visualizatin, SASIINSIGHT<ID. This highly visual, highly interactive cmpnent f the SAS system als prvides a lt f sphisticated statistical pwer which when put int the wrng hands culd be mis-interpretted and mis-used. In the right hands, the Explre cmpnent greatly enhances the statistical pwer ffered frm within the SASIPH-Clinical sftware envirnment. Help The help facility is prvided as an icn in the main menu, but is available in all areas f the sftware, usually under a pull dwn menu. Help is cntext-sensitive and can be used as an excellent learning tl fr unfamiliar areas f the sftware. Administratr The Administratr functinal cmpnent is nly displayed t t thse users wh have been given the jb f a Prduct Administratr. This is a very specialized task and is beynd the scpe f paper. The average user des nt see this fuctinal cmpnent. Exit The Exit icn supplies a user with varius ways f leaving the sftware. If yur Prduct Administratr has assigned yu the priviledge t get ut int the SAS System, then yu can temprarily exit ut t the Display Manager System and then quickly and easily return t SASIPH-Clinical sftware. Yu can als temprarily exit int yur wn applicatins and/r menuing systems. The Exit functinal cmpnent als checks whether yu want t save infrmatin abut Patient Grups and even prmpts t save the SAS Lg that is autmatically running behind the sftware. Fast exits are als pssible as well as the chance t cntinue when a mistake has been made. Recent SASIPH -Clinical Sftware Enhancements ~ '., The SAS Institute is kean t maintain the highest level f supprt t it's pharmaceutical custmers and aims t cntinually develp and enhance it's sftware accrding t the needs f the industry and regulatry agencies. Thanks t the cntinued feed back frm SASIPH-Clinical sftware custmers, the Institute has been able t enhance the sftware with the fllwing new desired features. Analysis : Descriptive Statistics Fr patient grups that include nly Patient level variables (ie measured nce per patient, eg age, sex, race), r Patient Event level variable (measured multiple times per patient, nt n a visit basis, eg medical Histry), the Descriptive Statistics Cmpnents under the Analysis functinal cmpnent is nw available. Als, fr Patient and Patient Event variables there is n lnger the need t chse a visit fr which t calculate statistics. Graphs: Bar Charts Gruped bar charts are nw available bth in vertical and hrizntal frmats, as well as blck charts. These generate side by side bar charts fr levels f the gruping variable. Previusly these charts were available nly fr results frm a percentage change analysis. A classificatin variable als allws yu t prduce multiple charts at separate levels f this variable. Graphs: Scatter Plts and Jined-Line Plts Any variable can nw be used fr the X-axis f these plts. Previusly, the X-axis was restricted t nly analysis variables. This nw facilitates plts ~ere the x axis has t be visit, r patient identifer, r any ther categrical variable. 918

4 _ r _J~_. " ~ c ~~ _ _, Graphs: Regressin Plts The interface and functinality fr prducing regressin plts have been enhanced t allw users t shw r hide regressin equatins n a graph. In additin, users can nw click n a single buttn t shw r hide the underlying scatter plt. This is useful when nly the regressin line and equatin are f interest. Graphs: Bar Charts and Pltting Symbls The list f pssible clurs, fill patterns, and symbls has been increased frm 10 t 20 t facilitate better bars, symbls, and clurs in charts and plts. Brwse and Tables: DriU dwn t Custm Screen In the Brwse facility, users can nw drill dwn frm patient listings t actual recrds fr an individual patient. These recrds can be presented in a default frmat r a frmat that represents smething that better matches the CRFs fr the study. This feature is als available fr drilldwn fr I-way, 2-way, and n-way frequency tables in the Tables cmpnent. Variable Creatin: Minimum fr a Patient User can nw create a new variable that cnatins the minimum f a secnd variable fr a patient, eg the new variable culd recrd minimum bld glucse value recrded fr the patient during a study. Exprt t MS-EXCEL(B) and SAS Transprt Files Thrughut SASIPH-Clinical sftware, users nw have the ability t exprt the current patient grup data t a MS-EXCEL spreadsheet r t create a SAS Transprt file t mve the infrmatin acrss platfrms. The exprt mechanism als allws subsetting t further restrict the data and variables t be exprted. The exprt t MS-EXCEL is available nly fr the Windws and OS/2 perating whereas the the exprt t SAS transprt files is available n all platfrms. Easy Access t Site Menu Systems Thrughut SASIPH-Clinical sftware users can invke a custmized (site specific) menu system/applicatin. This used t nly be available frm the Tables cmpnent but is nw available frm all screens displaying the "Other Task" pull dwn menu. Exit t Parent Menu System/Applicatin At sme sites SASIPH-Clinical sftware is invked frm a SAS based menu system/applicatin. Users can nw exit frm SASIPH-Clinical sftware and return t a parent system. Previusly n exit yu wuld exit the SAS System altgether. Administratr Utilities : Library Prduct Administratrs (PA) can nw display queued requested befre prcessing. They can als chse t cpy the queued requests t their Private Library instead f the Public Library. This allws PAs t edit users' prgrams befre making them available t all users Administratr Utilities: Frmat Search Path PAs can nw define a frmat search path fr each study. This feature enables sites wh use the same SAS frmat name fr different frmatting values t mre effectively use the prduct. Miscellaneus Additinal changes include clarifying infrmatin in messages and help windws, minr windw enhancements and bug fixes. 919 C.,

5 Future Directins In keeping with the SAS Institute's plicy t cntinue develping and enhancing it's sftware, the Institute is nw able t annunce SASIPH-Clinical(R) 2.0 sftware as the secnd release f the current sftware. SASIPH-Clinical 2.0 sftware is a new, Gill-based release f the Institute's clinical data review sftware. This majr new release f the sftware prvides a generatinal leap in technlgy mtivated by custmer experiences with the first release and by new tls available fr applicatin develpment in the SAS System. SASIPH-Clinical 2.0 sftware is a majr advancement bth fr internal review at pharmaceutical and bitechnlgy cmpanies and fr CANDAICAPLA. The result is a majr step frward in facilitating the gal f enabling spnsrs t use a single prcess fr internal review fr CANDAICAPLA preparatin. SASIPH-Clinical 2.0 sftware will be available with Release 6.11 f the SAS System n all PC and Unix envirnments, including the Macintsh and Pwer PC architectures. Key New Features f SASIPH ClinicaI2.0 Sftware All the existing functinality will be available and enhanced in the new sftware alng with the fllwing features :- Graphic User Interface (Gill) Fast perfrmance thrugh rbust prduct and study dictinaries integrated True spreadsheet brwsing with dynamic statistical tables and interactive graphs that prvide drilldwn facilities Drilldwn frm spreadsheet brwsing t all patient data, including CRF Images Pint and click key based transpse f brwsed data Dynamic ability t add new clumns t the spreadsheet, and cllapse acrss rws and clumns Standardised r custmised tables and reprts Crss-study brwsing, analysis, reprting, imprting, and exprting easily int the user interface. Ability t visually query data and create patient chrts based n these queries. Simplified study definitin prcess with built in diagnstics. Ability t define studies with multiple keys and supprt fr cmpsite keys. Enhanced perfrmance when accessing- nrmalized clinical data structures Built-in capabilities t speed the definitin f cnsistent study structures. Further details f functinality are decribed in the Schltzhauer, Fagan, Michael SUGI paper, Intrducing SASIPH-Clinical 2.0 Sftware, SUGI 1994 Prceedings. Cmplete details f functinality will be made available nearer the prductin date fr this exciting new release f the sftware. Summary The current SASIPH-Clinical sftware is a highly prductive tl fr the pharmaceutical industry. It enables pharmaceutical prffesinals t manage, analyse, reprt, and review f clinical trials data in a highly interactive way that can nly be ffered in the SAS system. The current sftware is cntinued t be enhance with each maintenance update f the SAS System. SASIPH-Clinical sftware is accepted sftware fr current CANDAICAPLA submissins by leading pharmaceutical cmpanies and regulatry agencies. These cmpanies have taken advantage f the latest features f SASIPH-Clinical sftware and reaped the bvius benefits that the sftware has given them by imprving their CANDAICAPLA submissins. \ \.. 920

6 Since the first release f the sftware, pharmaceutical and bitechnlgy cmpanies have gained mre experience with cnsidering clinical data review as a prcess necessary ina CANDAICAPLA submissin. Varius speakers at industry cnferences have identified the gal f using a single prcess fr internal review and CANDAICAPLA preparatin. SASIPH-Clinical sftware, and the new versin 2.0 sftware achieve this gal. SASIPH-Clinical 2.0 sftware prvides the next generatin in clinical review, by prviding fast, friendly, dynamic sftware that can perfrm virtually any task f interest t reviewers at spnsr firms and regulatry agencies. As with all SAS sftware, SASIPH-Clinical sftware is backed by cmprehensive technical supprt, excellent dcumentatin, and the knwlegde that it has passed the Institute's rigrus quality assurance and testing prcess. Cntact Address Brian Fredric Eurpean Prduct Manager Pharmaceutical Applicatins Divisin SAS Institute Eurpean Head Office Heidelberg, Germany Acknwled&ement The authr wuld like t thank ther members f the Pharmaceutical Applicatins Divisin fr input and reviewing drafts f this paper. The authr als wishes t thank the Vertical Market Applicatins Divisin, SAS Institute Inc., USA fr making material available fr this paper. SAS, SASIPH-CLINICAL, SAS/GRAPH, SASIINSIGHT are registered trademarks <Rl, and SASIPH-KlNETICS is a trademark (lm) f SAS Institute Inc., Cary, NC, USA. 921