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What is ACES ® and Where it’s Being Used For both tradi+onal and adap+ve trials, ACES addresses the secure communica+on complexi+es and regulatory concerns with interim analysis. Since introduced in 2010, we’ve deployed the webbased system in Phase 2 and Phase 3 adap+ve and tradi+onal trials across a variety of therapeu+c areas including oncology, CNS, infec+ous diseases, immunology, and psychiatry/psychology. Access Control Execu/on System Independent expert commiJees Data Monitoring and Endpoint Adjudica+on – while increasingly important, add administra+ve complexity for clinical trial sponsors. Securely managing the exchange of confiden+al informa+on for these commiJees also exposes sponsors to the great risk of compromising the integrity of their study.
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ACES - What is ACES And Who is Using It

Jul 16, 2015

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Page 1: ACES - What is ACES And Who is Using It

What is ACES® and Where it’s Being Used

For   both   tradi+onal   and   adap+ve   trials,   ACES   addresses   the   secure   communica+on  complexi+es  and  regulatory  concerns  with  interim  analysis.    

Since  introduced  in  2010,  we’ve  deployed  the  web-­‐based  system  in  Phase  2  and  Phase  3  adap+ve   and   tradi+onal   trials   across   a   variety   of   therapeu+c   areas   including   oncology,  CNS,  infec+ous  diseases,  immunology,  and  psychiatry/psychology.  

Access  Control  Execu/on  System  

Independent   expert   commiJees   –   Data  Monitoring  and  Endpoint  Adjudica+on  –  while  increasingly   important,   add   administra+ve  complexity  for  clinical  trial  sponsors.    Securely  managing   the   exchange   of   confiden+al  informa+on   for   these   commiJees   also  exposes   sponsors   to   the   great   risk   of  compromising  the  integrity  of  their  study.  

Page 2: ACES - What is ACES And Who is Using It

Why Sponsors are Implementing ACES Key Benefits

1.  Regulatory  Trust  and  Confidence  ACES®  is  foremost  designed  to  achieve  regulatory  trust.    It  conforms  with  the  FDA  Guidance  and  EMA  posi+on  on  DMCs  and  Adap+ve  Trial  Design  providing  evidence  that  a  trial  is  conducted  with  a  secure  process,  including  a  ‘who  saw  what  and  when’  audit  trail.    2.  Streamlined  Workflow  ACES  is  purpose-­‐built  to  comprehensively  manage  clinical  trials  and  interim  analyses,  including  the  documenta+on  and  firewalls  necessary  to  preserve  trial  integrity.    

ACES  automates  many  tasks  –  like  DMC  no+fica+ons,  reports,  or  randomiza+on  and  treatment  updates  for  IWRS  and  drug  supply.  It’s  web-­‐based  and  easily  deployed  in  any  seXng.    3.  Decision  Engine  Integra/on  It’s  what  sets  ACES  apart  from  ordinary  document  management  packages  like  Documentum  and  SharePoint-­‐based  apps.    ACES  ability  to  integrate  these  engines  is  helping  sponsors  of  all  sizes  make  even  their  most  complex  trials  more  rou+ne.    

Typical  Decision  Engines  can  involve  dose  selec+on,  randomiza+on  schemes,  drug  supply  triggers,  early  stopping  rules,  adap+ve  design  simula+ons,  and  condi+onal  power  calcula+ons.  The  results  are  reported  as  specified  in  the  protocol,  and  only  to  those  permiJed.  

Page 3: ACES - What is ACES And Who is Using It

Case Study - ACES Deployed in a Seamless Phase 2 / 3 Adaptive Trial

The  Trial  Design  and  ACES  Ini+ally,  randomize  subjects  equally  across  four  treatment  arms,  then  perform  interim  analysis  once  enrollment  reaches  about  100  subjects  in  each  arm.    

The  trial’s  interim  analysis  decision  rules:  1.  Early  termina+on  for  fu+lity  2.  Dose  selec+on:  select  one  or  two  most  

ac+ve  doses  (observed  paJerns  of  response  rates)  with  placebo  to  move  into  trial’s  2nd  stage  

3.  Sample  size  increase:  a  one-­‐+me  increase  based  on  condi+onal    power  for  2nd  stage  

 

The  dose  selec+on  rules  were  also  loaded  into  ACES,  together  with  the  randomiza+on  table  and  treatment  codes.  

Page 4: ACES - What is ACES And Who is Using It

Secure Reports and Communications Between Sponsor – DMC – ISC – Site

ACES  Supports  DMC  The  trial’s  DMC  reviewed  the  analysis  report,  suppor+ng  tables,  lis+ngs,  and  graphs,  provided  with  ACES  and  made  their  recommenda+on  to  the  sponsor.      

ACES  securely  stored  the  recommenda+on  and  triggered  no+fica+on  to  the  sponsor  company  representa+ves  to  review  and  accept.  

The  pivotal  VALOR  trial  valortrial.com            is  an  example  of  ACES  use  to  support  a  sample-­‐size  re-­‐es+ma+on  confirmatory  study  in  oncology.  

Page 5: ACES - What is ACES And Who is Using It

ACES Use Documented at ASCO Protecting the Integrity of Adaptive Designs

(Per  the)  Guidance  documents  by  FDA  and  EMA  for  DSMB  and  Adap>ve  Trial  Design,  sugges>ng  ‘A  well-­‐trusted  firewall  established  for  trial  conduct  ...    can  help  provide  assurance  that  sta>s>cal  and  opera>onal  biases  have  not  been  introduced.’    

Cytel’s  Cyrus  Mehta  and  Eric  Silva  with  Sunesis  Pharmaceu+cals  co-­‐authors  From  their  accepted  ASCO  2012  poster  presenta+on