Pediatric Oncology Data Collection in MultiCenter Studies Pediatric

Pediatric Oncology Data Collection in Multi-Center Studies Pediatric Oncology Networked Database (POND) International Outreach Program St. Jude Children’s Research Hospital

POND Pediatric Oncology Networked Database www. pond 4 kids. org

POND 4 Kids. org Objective: Compare clinical research data at multiple sites. Features: – Web-based data collection – Multiple sites – each with local control on who can enter, share and view data – Customized Quick Entry Forms – Multilingual User Interface – Online Reports and Data Exports – Provided at no cost to partner hospitals

Patient Registration Page

Locating a Specific Patient Record: Modes - Browse, Search

The Patient Summary Page Diagnosed Cancers Customized “Quickforms” “Standard” Clinical Forms

Treatment Summary Page

Laboratory Summary Page

Laboratory Data Page

Menus and Data Entry Timestamps in 24 hr International format Calculated values

Cancer Diagnosis - Appropriate class codes, staging, histologies are presented via “pull-down” for each cancer type Repeating fields; Create as many as required As with all pull down terms, these histologies are translated

Patient Status Detail Note different second-level fields due to different “Patient Status” selection

Custom Quick. Forms – Data Entry

Quickforms Builder - As introduced earlier, Quickforms offers an expedient means to enter or view data normally entered or viewed in multiple individual forms. Using the utility depicted below, Quickforms may be easily created and modified. All necessary data dependencies are automatically enforced. For example, if a lab value is requested, the required timestamp information will be tied to it.

Sharing Quick. Form Templates Quickforms - As with Protocols, Quickforms may be shared to the global POND community.

Quickforms Manager - Quickforms may be modified, activated, deleted, copied and shared globally.

Drug Database - Drugs names are translated and maintained in the centralized POND database in order to avoid confusion between local, common, generic, and proprietary nomenclature. Drugs are also categorized based upon normal usage.

Cancers Database - Similarly, common cancer nomenclature is maintained in the central POND database. Reference is made to the standardized ICD coding systems.

Protocol Builder - Protocols may be developed by any Site admin. completed protocols may then be employed locally or optionally shared to the global POND Protocol Library

Protocol Builder - Utilizing the online tool, Protocols are constructed action-by-action. An action may be the administration of a drug, a lab test, an examination, or any other action taken on behalf of a patient. Drug dosage formulas may be included which will then auto-calculate recommended dosages based upon an individual patient’s current vital signs information.

Protocol Manager - Protocols may be modified, activated, deleted, copied and shared globally. Activated protocols may never be modified, but may be copied and modified as a revision.

Data Access Controls

Sharing Data Between Sites Inter-Site Data Sharing - Based upon various criteria such as disease group, or patient. All data is access is controlled by local Site Admin.

Sharing Data with other POND Users

Online Reports

Data Exports Excel Exports

Reporting on Protocols

Survival reports

… complete with graph

Toxicity reports (optionally broken by protocol cycle)

Data Management Infrastructure Sharing Data within AHOPCA Panamá Nicaragua Web. MISPHO Epidemiology Costa Rica POND Honduras Hodgkin lymphoma Mc. Master Nutrition El Salvador Local data entry Local queries Guatemala PI queries PI reports

POND Summary • Secure storage of clinical research data • User maintains control of the data • Flexible data sharing • Easy-to-use web-based technology • Multilingual ability • Global access via the internet

POND – Current Users • The Central American Pediatric Hematology/Oncology Association (AHOPCA): • Guatemala, El Salvador, Honduras, Costa Rica, Nicaragua, Panama, Dominican Republic • Mexico - Culiacan, Guadalajara • Paraguay • Morocco

POND Future Development • Users are the primary source of requests for additional features • As new features are added, they appear immediately (even while logged on) • Enhanced reporting options, support for hematology patients, and improved data integrity functions are the focus of development for the first quarter of 2005

POND Requirements • Any computer that has an internet connection • Any internet browser: Internet Explorer 5. 0 or higher, Mozilla, Opera, Mac, etc. • Use of the most recent version of the chosen browser is recommended

POND Cost • Free • Limited technical support

To Learn More www. pond 4 kids. org Yuri Quintana, Ph. D Informatics and Education Director, Yuri. Quintana@stjude. org Scott Howard, MD, MS Director of Clinical Trials, Scott. Howard@stjude. org International Outreach Program St. Jude Children’s Research Hospital http: //www. stjude. org/international

MISPHO Collaborators POGO