This section will not be required for the majority of original INDs. Most novel investigational drugs (such as the BGTC candidates) do not have prior clinical data unless the drug has been studied in other countries or otherwise tested in humans under other legal exemptions. Another exception would be if you have experience with your asset in another indication. Analogues may be used to help define specific parameters (e.g., safety profile, dose range, and tissue tropism) to use as a baseline comparison for clinical data for your product. Please see the Pre-IND section for more information on analogue selection.
Do you have clinical data for your product?
Yes - Applicable: See description below on how to approach this section
No - Not applicable: Proceed to Non-Clinical written and tabulated summaries
The overall goal of the clinical overview section is to provide the FDA with a brief overview of your product’s clinical data, key findings, and any other relevant information (e.g., pertinent animal data or product quality issues that may have clinical implications). For more information on how to structure this section and key information to include, check out the clinical overview template below and leverage the pro tips below.
Clinical overview template
What you should include | Potential table of contents |
|---|---|
Highlight how the findings support critical parts of the prescribing information |
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Note: You can use graphs and tables in the body of the text for brevity and ease
Pro Tip: Ensure the document length is no more than 30 pages maximum, unless it contains complex data. Some other points you should consider highlighting in your clinical overview section include:
Discussion and justification of the clinical development plan for your product (include critical study design decisions)
Good clinical practice (GCP) status of the studies being submitted
Provide benefits and risks evaluations based on the conclusions of the relevant clinical studies
Consider the efficacy and safety findings which support the proposed dose and target indication
Consider evaluation of how prescribing information and other approaches can optimize benefits and manage risks
Address any issues (particularly around efficacy or safety) that you may have encountered in your development and how you resolved them
Disclose any unresolved issues and indicate what effect they may have on your program