As part of an IND application, clinical protocols are submitted for review. A clinical trial protocol should be written for each phase of the clinical investigation according to FDA specifications. IND investigations are divided into three phases:
Phase 1 — this phase is the initial introduction of the drug to human subjects and may be conducted with patients or healthy volunteers. Phase 1 identifies specific reactions to be further studied in subsequent phases. The goal of phase one is to document reactions human subjects have to the drug at various doses.
Phase 2 — Phase 2 is a more controlled study specifically focused on the effectiveness of the drug treatment. Phase 2 isolates and documents short-term side effects and other risks, as well as how the drug changes the disease state.
Phase 3 — the largest phase of the clinical investigation. The purpose is to expand on Phase 2 findings and build a larger body of clinical evidence. This is when the benefit-risk ratio is established and potential labeling concerns are gathered.
Protocols for clinical investigations in all three phases must be evaluated by the FDA as part of the IND application. Additional protocols can be submitted an amendment to the application when they are developed.
Here are some things to keep in mind when writing IND clinical investigation protocols:
Specify all parts of the study related to safety
Develop study enrollment criteria based on disease condition background risks, label warnings and precautions, known toxicities in animals
Include clear descriptions of clinical procedures, trial design and patient selection criteria
Detail recording, collecting and reporting methods
The FDA offers guidance materials that should be reviewed and followed for the best outcome.
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