This month, the Clinical Data Interchange Standards Consortium (CDISC) unveiled data standards user guidelines for breast cancer. CROS NT looks at the implications of data standards and smart trial design in the field of breast cancer.
Breast Cancer is the most frequently diagnosed cancer in women worldwide. According to CDISC, breast cancer accounts for 23% of total cancer cases. CDISC has therefore established the Therapeutic Area Data Standards User Guide for Breast Cancer (TAUG-BrCa) to support Sponsors on using CDISC standards for data collected in breast cancer trials.
The TAUG-BrCa is a guideline for applying CDISC standards such as CDASH, SDTM and ADaM. Specific examples laid out in the user guide include:
- Sample case report forms (CRFs)
- CDASH metadata for sample CRFs
- Domain models and datasets from SDTM implementation guide
- SDTM dataset examples
- Analysis datasets compliant with ADaM
As a CDISC Gold Member, CROS NT has immediate access to new CDISC guidelines including the full TAUG-BrCa user guide. The TAUG-BrCa lays out data guidelines for breast cancer trials so biostatisticians, programmers and data managers can collect, analyze and report data appropriately.
Implementing data standards is good practice for oncology trials which are complex in nature. Breast cancer trials can be unique due to various treatment combinations, regimen modifications, slow and expensive recruitment and unique trial designs and endpoints.
CROS NT recommends involving a biostatistician with oncology expertise in the protocol and trial design in order to define sample size, endpoints and inclusion/exclusion criteria – which are unique in oncology trials. The biostatistician will be familiar with CDISC standards that should be incorporated into the trial design.
The TAUG-BrCa looks to identify common technical specifications, criteria methods and data standards. Using a CRO with expertise in CDISC standards and experience in oncology trials can guarantee an increase in quality and reduce project costs especially when using a validated database structure and validated CDISC formats. These factors usually distinguish early phase oncology trial success from failure.
CROS NT has extensive experience in conducting oncology clinical trials, and we have a team of biostatisticians and programmers with particular expertise in breast cancer. As part of the CDISC Gold Partner network, we can consult on the TAUG-BrCa and guide Sponsors through their breast cancer trial design (including Adaptive Trial Design), statistical methodology, implementing CDISC standards and support with regulatory submissions and feedback.