MEDIDATA/RAVE. from A Biostatistician s Perspective

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1 MEDIDATA/RAVE from A Biostatistician s Perspective Presented by: Mehmet Kocak, Ph.D. Assistant Professor at, UTHSC Resources: Report of the Clinical Trials Working Group of the National Cancer Advisory Board : Restructuring the National Cancer Clinical Trials Enterprise June 2005

2 Background Pediatric Brain Tumor Consortium (PBTC) has developed a web-based electronic remote data capture (erdc) system since its inception in Most other Cooperative Groups such as SWOG and COG also developed their own systems locally. Advantages Allows for customization at any time Disadvantages Results in independent/disparate systems Requires duplicative effort across Groups

3 Cancer Clinical Trial Centers

4 NCI Sponsored Cooperative Groups American College of Radiology Imaging Network American College of Surgeons Oncology Group Cancer and Leukemia Group B Children's Oncology Group Eastern Cooperative Oncology Group European Organization for Research and Treatment of Cancer Gynecologic Oncology Group National Cancer Institute of Canada, Clinical Trials Group National Surgical Adjuvant Breast and Bowel Project North Central Cancer Treatment Group Radiation Therapy Oncology Group Southwest Oncology Group

5 NCI Sponsored Consortia and Programs Adult Brain Tumor Consortium Pediatric Brain Tumor Consortium Pediatric Preclinical Testing Program Childhood Cancer Survivor Study - New Public Access Data Tables Available New Approaches to Neuroblastoma Therapy Blood and Marrow Clinical Trials Network (BMT CTN) Myeloproliferative Disorders Research Consortium The COG Phase I/Pilot Consortium

6 Standardization Initiatives by Clinical Trials Working Group (2005) Create, in partnership with the extramural cancer research community, a national cancer clinical trials information technology infrastructure fully interoperable with NCI s cancer Bioinformatics Grid to improve cost effectiveness and comparability of results across trials and sites. In consultation with industry and FDA, develop standard Case Report Forms incorporating Common Data Elements to improve information sharing among cancer researchers and optimize data requirements. Build a credentialing system for investigators and sites recognized by NCI and industry to allow faster trial initiation and keep the investigative community abreast of legal, safety, and regulatory changes. Develop commonly accepted clauses for clinical trial contracts with industry to reduce the lead-time needed to open trials.

7 Standardization Initiatives by Clinical Trials Working Group (2005) NCI purchased a license from the commercial software company Medidata All NCI Sponsored Cooperative Groups were mandated to adopt Medidata RAVE for new studies activated after April 1, 2012 PBTC and other NCI sponsored consortia are also currently in the process of transitioning to RAVE.

8 What is RAVE? RAVE is an electronic data capture (EDC) system developed by Medidata in 1999 and it is the first thinclient and web-based system that is browser- and operating system-independent, developed for capturing, managing and reporting clinical research data. As a Clinical Data Management System (CDMS) software application, it facilitates the conduct of clinical research throughout the NCI-sponsored clinical research enterprise. Here are some features of Medidata RAVE: It is a unified platform for study design, electronic data capture, local lab data capture, migration management and reporting; It offers language translation tools that enable application screens and study definitions to be presented in any language; It has double data entry capability that allows for paper and paper/edc hybrid studies to be run on a common platform

9 What is RAVE? Features of Medidata RAVE (Continued) It offers global library and study design editing tools to accelerate study build; Its elearning module enables investigative sites to complete Rave training for a given study directly within the system; Rave Web Services application programming interface (API) enables developers to integrate third-party systems (RSS, OPEN, etc.) with Rave; Medidata Rave Safety Gateway helps study sites to electronically transfer serious and non-serious safety data sponsors' safety systems; Medidata Balance is a tool used for randomization including block randomization.

10 What is RAVE? Medidata Rave's study build tool, Architect, features a complete set of capabilities designed to allow study teams with research and data management backgrounds, not necessarily programming expertise, build and deploy studies without the need to hand off to programming professionals. Accessing Architect simply requires access to an Internet browser and a secure login. Study teams can easily configure CRFs, sophisticated workflows, data blinding, source document verification and review requirements, dictionary coding and even complex edit checks via a point-and-click interface and design specifications are created and updated automatically.

11 What is RAVE?

12 CTSU-RAVE Integration

13 What is CTSU? A service of the National Cancer Institute (NCI) that provides clinicians across the United States and Canada access to cancer treatment trials. A project funded and directed by the NCI Cancer Therapy Evaluation Program (CTEP) and operated by Westat and the Coalition of Cancer Cooperative Groups Membership Registration is facilitated by CTEP Identity and Access Management (CTEP-IAM) System Required for all investigators who treat patients or prescribe medications Now required for all others at clinical trial sites who need access to protocol documents, forms, educational documents, patient enrollment, and data submission.

14 Purpose of CTEP-IAM? To provide a central validation of all staff involved in the conduct of NCI/CTEP-sponsored trials To facilitate identification of investigators and study team found on multiple Group rosters To provide access to other CTSU and CTEP databases and programs To track/support regulatory compliance for Group Administrators and CTSU regulatory staff Membership Activation of Investigators A CTSU investigator must be an active member in the NCI-CTEP Database and on the treatment roster of at least one Cooperative Group (or other relevant organization, e.g., Phase 2 consortia) in order for membership to be activated. The CTSU verifies the physician s credentials with the NCI and Cooperative Group/organization. NCI-CTEP and organization membership databases are dynamic. Therefore, these credentials are also verified at site registration and patient enrollment.

15 Regulatory Support System (RSS) Contains regulatory information for ALL NCI sponsored treatment (Phase 1, 2,& 3) and prevention trials Also contains regulatory information for select non- Cooperative Group trials, e.g., Phase 2 Consortia trials Operations offices can view ALL regulatory information for each of their sites Provides one location to send protocol specific site registration documents, regulatory and other protocol required documentation, for all NCI sponsored trials Establishes and communicates policies and procedures related to regulatory issues such as Federal Wide Assurance Requirements U.S. Regulatory Requirements Foreign Site Participation Requirements It provides Help Desk services

16 RSS snapshots for my role

17 RSS snapshots for my role

18 RSS snapshots for my role

19 Oncology Patient Enrollment Network (OPEN) A web-based, 24/7 patient registration system for the enrollment of patients onto clinical trials conducted by NCIsponsored Cooperative Groups and consortia. This system was developed to leverage the existing CTSU Enterprise system for regulatory and roster information and the existing integration of the CTEP Enterprise and Cooperative Group management systems. All NCI supported Cooperative Group trials are activated in the Oncology Patient Enrollment Network (OPEN. All RAVE studies conduct the patient enrollment on the OPEN system and the data are uploaded to RAVE

20 OPEN Snapshots for my role

21 OPEN Snapshots for my role

22 CTSU-RAVE Integration

23 imedidata from a Biostatistician s eye

24 imedidata

25 imedidata

26 imedidata

27 imedidata

28 imedidata

29 imedidata

30 imedidata-sas OnDemand

31 imedidata-sas OnDemand

32 imedidata-sas OnDemand

33 imedidata-sas OnDemand

34 Processing RAVE Data

35 Processing RAVE Data

36 Processing RAVE Data

37 Processing RAVE Data %include "C:\Mehmet_Kocak\macros\mergeinboth.sas"; libname cog1123 "C:\Mehmet_Kocak\COG\ACNS1123\data\data2013_09_05\"; %macro filecopier(fromlibrary=slq100, tolibrary=work, startpos=1); options nonotes; proc sql; select distinct memname into :datasets separated by ' ' from dictionary.tables where libname="%upcase(&fromlibrary)"; quit; proc sql; select distinct memname, substr(memname,&startpos,100) into :ignore, :outdatasets separated by ' ' from dictionary.tables where libname="%upcase(&fromlibrary)"; quit; %put Datasets read from %upcase(&fromlibrary) library are &datasets; proc sql noprint; select distinct count(*) into :noffiles from dictionary.tables where libname="%upcase(&fromlibrary)"; quit; %do i=1 %to &noffiles; %let cfile1=%scan(&datasets,&i);%let cfile2=%scan(&outdatasets,&i); data &tolibrary..&cfile2; set &fromlibrary..&cfile1; run; %put &cfile1 dataset has been read from %upcase(&fromlibrary) library and its copy has been created in %upcase(&tolibrary) library; %end; option notes; %mend; %filecopier(fromlibrary=cog1123, tolibrary=work, startpos=6);

38 Processing RAVE Data QFRZ_ACNS1123_ADVERSE_EVENTS dataset has been read from COG1123 library and its copy has been created in WORK library QFRZ_ACNS1123_BASELINE_NEUROSURG dataset has been read from COG1123 library and its copy has been created in WORK library QFRZ_ACNS1123_CYTOLOGY_AND_TUMOR dataset has been read from COG1123 library and its copy has been created in WORK library QFRZ_ACNS1123_DEATH dataset has been read from COG1123 library and its copy has been created in WORK library QFRZ_ACNS1123_ELIGIBILITY dataset has been read from COG1123 library and its copy has been created in WORK library QFRZ_ACNS1123_FOLLOW_UP dataset has been read from COG1123 library and its copy has been created in WORK library QFRZ_ACNS1123_INDUCTION dataset has been read from COG1123 library and its copy has been created in WORK library QFRZ_ACNS1123_LESION_ASSESSMENT dataset has been read from COG1123 library and its copy has been created in WORK library QFRZ_ACNS1123_NO_TREATMENT dataset has been read from COG1123 library and its copy has been created in WORK library...

39 RAVE Data-Examples of Formats

40 RAVE Data-Examples of Formats

41 RAVE Data-Examples of Formats

42 RAVE Data-Examples of Formats

43 RAVE Data-Examples of Formats

44 RAVE Data-Examples of Formats

45 Questions??? Comments!!! Suggestions

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