Biostatistics & Biomathematics

Vision and Mission

The Division of Biostatistics & Biomathematics provides an essential component of the scientific basis for clinical research conducted in the Department of Radiation Oncology:

• Database development and management
• Developing designs for prospective clinical trials, laboratory experiments, and observational studies
• Case-control analyzes and retrospective reviews
• Statistical analysis of data arising from these trials, experiments, and reviews
• Outcome analyses
• Mathematical modeling of clinical data, outcomes, and clinical decision making
• Education of faculty and fellows
• Setting up Department policies insuring scientific integrity in all activities

The mission of the Division of Biostatistics & Biomathematics is to provide biostatistical leadership, collaboration, consultation, and quantitative research resources to clinical and laboratory scientists engaged in the planning, conduct, analysis, quality assurance, and interpretation of research studies.

The Data Management section of the Division of Biostatistics & Biomathematics provides a full range of data managing services for clinical trials and other types of research studies.

Services include:

• Designing study forms and case report forms
• Assistance in writing protocols
• Database programming and development
• Randomizing patients
• Monitoring the course of a trial, ensuring that the protocol is followed
• Data entry
• Quality assurance and auditing
• Filing necessary forms to regulatory authorities
• Providing data summaries to the PI and raw data files to the trial’s biostatistician

Data Management

The Division of Biostatistics & Biomathematics supports research-oriented databases and data management needs for Radiation Oncology through the following activities:

• Design of databases
• Design of forms and screens for databases
• Design of software for data entry, update, and review
• Migration of older databases from SAS
• Migration of data entered in Excel, Access, etc
• Data entry and data management
• Routine database backups
• Queries of existing databases
• Integration with Departmental clinical and administrative databases
• Management of users, passwords, access rights
• Consulting

Guidelines for Collecting and Coding Data

• Please consult us before starting data collection.
• Keep in mind the recent HIPAA regulations on preserving patient privacy. Many times, collecting patient names, addresses, and personal information is not needed for the project. In this case use both patient numbers and initials to identify patients (redundancy is needed to guard against mistakes); keep your own list with sensitive data. If including patient personal data in the database is beneficial, then we will take special precautions to ensure patient privacy (separate access rights).
• Excel spreadsheet may be acceptable for a small one-time project, where there is no need for periodic updates and the data is collected by one investigator. However, entering and coding data in Excel is particularly prone to errors of typing, consistency, etc. Cleaning such errors puts additional burden on the statistician performing the project and delays the analysis. To minimize errors make sure to not mix numeric and text data (a common error is putting comments or question marks in a column of numbers; please designate an additional column for comments). There should be a description of the variables, and the first raw should have variable names or symbols. If you code qualitative categories, please list the categories in each column in the rows beneath data, for example: "M=Male, F=Female" in a "gender" column.
• If you are familiar with Microsoft Access software, then a preferable way of storing data for a small-project is using Access tables.
• We recommend putting your database on our server, "biostat". This is particularly beneficial for a longer-term project or one which involves updating the records. We will create the database for you, when you prepare an Excel sheet with the data to be read-in, or a detailed description of variables. The database residing on the server will be regularly backed-up and professionally supported, with secure access rights. An additional benefit is the possibility to enter or review data from any Mass General Brigham computer, and by several people simultaneously.
• Depending on needs, databases on the server can be accessed in several ways, from an Excel-like Access spreadsheet to a specialized program with screens, menus, etc.

Clinical Database Administration Policy

The goal of the policies on administration of clinical records databases in the Department of Radiation Oncology is to facilitate an efficient access to accurate and up-to-date records for clinical research and for treatment process improvement; while ensuring integrity and security of data, protection of patient privacy in compliance with HIPAA, and scientific integrity of research.

The following policies should be implemented and observed:

1. The Department owns all clinical data that are generated in the Department.
2. Databases of clinical data are stored on Departmental servers maintained and administered by the Division of Biostatistics and Biomathematics.
3. Access to databases is password-protected.
4. Passwords are issued only to individual users and cannot be shared.
5. Users have different levels of access rights, depending on user, database, and time period. The different levels of access rights are: ability to read part of the data, read all data, approve records, add new records, modify data.
6. Adding new records to databases and modifications to the data is reserved for the staff of the Division of Biostatistics and Biomathematics.
7. Residents and fellows may be granted only read access to the part of the database.
8. Senior physicians responsible for studies will have the access right to review and approve the data pertaining to their studies.
9. Patient sensitive data, protected by HIPAA regulations, will be stored in separate tables. The access rights to these data will be limited to authorized personnel.
10. If the data are to be shared with other Departments or institutions, approval must be obtained from the Director of Biostatistics and Biomathematics. Data must be stripped of data elements proscribed by HIPAA regulations.

Biostatistics

The Division of Biostatistics & Biomathematics supports biostatistics needs for Radiation Oncology.

• Study design and sample size calculations
• Monitoring of study conduct, preparing standard reports
• Statistical analysis
• Mathematical and biologic modeling
• Assistance with preparation of the manuscripts
• Consulting

Additional biostatistics support is available through the MGH Biostatistics Center

Research Projects

The Division of Biostatistics & Biomathematics currently supports the following databases:

• Tumor proton registry
• Sarcoma
• Breast cancer
• Prostate cancer
• Lung cancer
• Small cell lung cancer
• Eye orbit cancer
• Protocol 99-278
• Meningioma
• Brain metastases from breast cancer
• Rectal cancer
• Chondrosarcoma
• Tracheal cancer

Publications

Publications from Andrezj Niermierko, PhD and Saveli Goldberg, PhD