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calgb.org > About the CALGB > Role of the Statistical Center
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Organization
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The Statistical Center is responsible for all data management and statistical activities within the Group. Statisticians and Data Coordinators are members of all CALGB disease and modality committees and actively participate in the planning, execution and analysis of Group research. Each Group activity has been assigned to a Statistician/Data Coordinator manager team. This team approach facilitates collaboration with the Group's clinical membership and allows the team to develop detailed knowledge about the individual areas of Group science. Statistical Center staff are also members of the Group's administrative committees. The Statistical Center is comprised of these departments: Biostatistics, Bioinformatics, Data Operations and Information Systems.
The Group Statistician coordinates all the activities of the Statistical Center and directly supervises the Statistical staff. Immediate responsibility for supervision of the data processing and data management activities lies with the CALGB Data Operations Director. Administrative programming, database maintenance, and application enhancements are controlled by the CALGB Director of Information Systems. Forms development and education/training activities are performed by the Quality Assurance section.
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Study Design and Implementation
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The Statistical Center staff, Data Coordinators and Statisticians are involved in all phases of study design and development. CALGB Statisticians provide the statistical collaboration necessary to develop scientifically sound studies. The Statisticians evaluate the feasibility of a proposed study design and assess the likelihood that the study's goals will be achieved based upon the Group's experience with similar studies. As the study concept is formalized into a protocol document, the Statistician and Data Coordinator review the protocol drafts ensuring that there are clear and consistent definitions of study objectives, eligibility criteria, primary analysis endpoints, evaluation criteria (such as toxicity and response definitions) and guidelines for removal of patients from protocol therapy. The registration instructions are checked for clarity, especially for studies with multiple treatment phases. The Statistician drafts the statistical considerations section of the protocol, estimating the accrual necessary to achieve the primary analysis endpoints.
The data submission section of the protocol is also the responsibility of the Statistical Center. The Study Chair, the Statistician, and the Data Coordinator define the data items which need to be collected to achieve the study objectives and assess the existing forms to verify that they are appropriate to collect the required information. In some instances, when a new form is required, the design and development of which is undertaken in collaboration with the Forms Committee.
The study statistician is responsible for the design and production of randomization materials for new protocols, producing treatment assignment lists for each stratum defined by prognostic factors. Treatment assignments are balanced across institutions and across strata to ensure reasonably equivalent numbers of patients on each treatment arm within each institution and within each stratum. The data coordinator, in collaboration with the registrar and statistician, drafts the confirmation of registration form which will be used during the randomization process.
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The CALGB Database
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Quality Control, Updating and Maintenance
Each study is assigned to a data coordinator and a statistician when it is in the concept stage. After activation of the study, the data coordinator is solely responsible for the content of the computerized data for that study.
Forms received are first checked for proper identification. Patient, study, and institution numbers are used, to varying degrees, to link together various components of the database. An extensive list of form and study specific checks are performed on each form, and a newly received form is compared with the complete paper record or computerized record on hand for that patient. This record provides a detailed picture of the patient's progress through the study, and the individual data elements must be logically consistent with the disease and with protocol requirements. Information is monitored for completeness, consistency and "significant events," such as severe or unusual toxicities.
After the forms are reviewed, they are given to a data entry operation who keys the information into transaction records with a "batch" number attached to each record. The data coordinator reviews each batch and makes any necessary corrections. When doing a batch review, there are a variety of checks on the keyed data (e.g., data type and numeric range checks, and cross-field data checks). The system prepares a report describing the transactions performed and any errors detected. This report is inspected by the data coordinator and, if necessary, corrections are made to the database.
The checking and review procedures detect potential inconsistencies and errors in the information submitted by the institution. If necessary, a query is sent by the data coordinator to resolve these problems. A copy of the query, the response, and documentation of modified information is kept in the patient paper file.
Study chairs are required to formally evaluate each patient record at key points in the patient's progress through the study. These evaluations are recorded on the CALGB Case Evaluation Form. The data coordinator monitors the data for occurrence of an event such as completion of a phase of treatment or removal from protocol. If such an event has occurred, a form is initiated containing the data coordinator's evaluation and is sent to the study chair with a printout of the patient's computerized data. The study chair reviews this material and compares the computerized information with the forms that have been submitted. The evaluation form and the computerized summary are then returned with corrections, comments and a complete evaluation for review and processing by the data coordinator. A final copy of the Case Evaluation is sent to the institution.
The computerized printout used by the study chair presents the data in a form structure. These printouts provide the study chair with an efficient mechanism for comparing the computerized record with the source forms from which it was produced and is an important part of the quality control of the CALGB database.
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Interim Reports
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The Statistical Center prepares interim reports for each semi-annual CALGB Group meeting. The meeting Agenda Book contains reports for studies open at any time during the period since the previous Agenda Book was produced. The extent of each report is determined by the study's status and the quantity of available data. For studies, accrual and available toxicity data are reported. The status of case records is tabulated in each report. Projected time to termination and follow-up requirements are calculated wherever meaningful.
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Final Reports and Publications
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Major analyses are prepared for every CALGB study at a suitable time after the termination of patient entry (determined by the statistician and the study chair). Most studies are written up as manuscripts and submitted for publication.
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Communication and Education
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CALGB organizes and conducts periodic data management workshops. The purpose of these workshops is to:
- Foster communication among members of the CALGB data management community.
- Provide a forum for discussion of data management concepts.
- Resolve specific data collection problems.
- Assist institution data managers to organize and maintain their respective data management offices.
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For More Information Contact:
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Hock Plaza
2424 Erwin Road
Suite 802
Durham, NC
27705
Main Phone: 919-668-9350
Registration Phone: 919-668-9396
Registration Fax: 919-668-9397
For CALGB Database/Patient Registration/LabTrak/Web Report/General Web Site Questions:
CALGB IS Help Desk: Help Desk Staff
8 AM and 5 PM (Monday - Friday)
Phone: 877-44-CALGB
In case of emergency, support is available 24 hours 7 days a week.
Contact Emergency Technical Support:
Pager number: 888-716-6005.
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