Conducting Companion Diagnostic Studies in a CLIA-certified Laboratory
Overview:
Lab-Developed Tests (LDTs), Research Use Only (RUO), Investigational Use Only (IUO), and In-Vitro Diagnostics (IVDs) are all patient-response test equipment commonly used to evaluate the clinical validity of a Companion Diagnostic (CDx) test.
FDA Good Clinical Practice (GCP) requirements define study Sponsor regulatory obligations that are required to be met for a study’s data to be considered valid. CROs and CLIA-certified labs providing CDx testing services must continue to conform to CMS CLIA laboratory requirements per §42 CFR 493 in the provision of their study services. CDx study protocol design can affect study subject risk and requires careful planning so as to avoid regulatory complications.
This webinar will define an approach for determining how GCP and CLIA requirements can be assessed and navigated based protocol design and study planning.
Why should you attend:
- Study subjects could be put at unnecessary risk by the use of inappropriate equipment being used in a CDx study.
- Companies conducting Companion Diagnostic / drug studies could find their clinical data considered invalid for not meeting GCP requirements.
- Clinical laboratories supporting Companion Diagnostic / drug studies could lose their CMS certification due to a failure to comply with CLIA regulations.
- Companies providing IVD equipment for CDx studies may incur unexpected costs when dealing with CROs and CLIA-certified labs.
Areas Covered in the Session:
- Definition of CDx terminology
- Companion Diagnostic (CDx)
- Lab-developed test (LDT)
- Research Use Only (RUO)
- Investigational Use Only (IUO)
- In-Vitro Diagnostic (IVD)
- Good Clinical Practices (GCP)
- Center for Medicare Services (CMS)
- Clinical Laboratory Improvement Act: CLIA
- GCP requirements as related to CDx test equipment
- CLIA requirements for clinical studies per §42 CFR 493
- Assessing subject risk in CDx studies and determining CDx equipment based on subject risk
- Determining appropriate testing equipment maturity requirements to support a CDx study based on subject safety
- Using method transfer and validation as a means to maintain GCP and CLIA compliance
- Planning for CLIA lab support of a CDx study
Who Will Benefit:
- Members of the regulatory staff of drug companies sponsoring CDx clinical trials
- CROs and CLIA lab managers providing CDx testing services
- R&D team leaders and regulatory specialists from IVD manufacturers providing RUO, IUO or IVD test equipment to CDx studies
- Principal Investigators of CDx studies