Definition
Clinical Hold is an FDA order directing a sponsor to delay a proposed clinical investigation or suspend an ongoing study. Clinical holds are imposed when FDA identifies concerns that must be resolved before trials can proceed safely.
How Clinical Holds Work
FDA issues clinical holds through formal communication specifying the deficiencies. Sponsors cannot enroll new patients or dose existing patients (unless continuation is safer) until the hold is lifted.
Clinical Hold Types
| Type | Timing | Effect |
|---|---|---|
| Full Hold | Proposed or ongoing trial | All clinical activities stopped |
| Partial Hold | Ongoing trial | Specific aspects suspended |
Common Reasons for Clinical Holds
- Safety Concerns: Serious adverse events or toxicity signals
- Manufacturing Issues: CMC deficiencies or contamination
- Protocol Problems: Inadequate patient protections or design flaws
- Data Integrity: GCP violations or fraudulent data
- Preclinical Gaps: Insufficient animal study support
Why BD Teams Track Clinical Holds
For business development professionals, clinical holds are critical risk factors:
- Deal Implication: Active holds significantly impact asset valuation and timelines
- Due Diligence Focus: Review clinical hold history and resolution strategies
- Opportunity Signal: Assets recovering from holds may be available at discount