The Food and Drug Administration (FDA) has released a new guidance that outlines the criteria for determining selective safety data collection – the reduced collection of certain safety data in late-stage pre-approval and post-approval clinical trials. When the safety profile of the drug is well understood, comprehensive safety data collection may be of limited value and therefore, a selective safety data collection approach may be more beneficial. This approach allows clinical trials to be conducted on a larger scale resulting in more efficient data.
The general principles in the guidance include information on the types of safety data that should be collected and the criteria for determining when additional safety data collection is necessary. It also includes information on baseline data, the benefit-risk considerations, and early consultations with the regulatory authorities. Most importantly, it emphasizes that the safety of patients should not be compromised by using selective safety data collection.
General Principles for Consideration
- Ensuring the Safety of Trial Participants
- Selective safety data collection does not impact the monitoring and clinical care of the trial participants and selective safety data collection does not negate the need for reporting obligations of health care professionals or reporting to regulatory authorities.
- Factors That Contribute to a Conclusion That the Safety Profile of a Drug Is Sufficiently Characterized to Justify Selective Safety Data Collection
- To justify utilizing selective safety data collection, it is important to consider the regulatory status of the product, the mechanism of action, the safety profile of the product, product exposure, the safety profile in clinical trials, and the comparability of the product and route of administration. Planned and previous trial design also needs to be considered, as well as pharmacology and toxicology data.
- Baseline Data
- Selective safety data collection would have no impact on baseline data collection.
- Data That Should Generally Be Collected
- Serious adverse events, including important medical events, medication error/overdose (intentional or unintentional), adverse events that led to study drug discontinuation, pregnancy and lactation exposure and outcomes, and adverse events of special interest (including laboratory abnormalities) identified in the protocol as critical to safety evaluations.
- Data That May Be Appropriate for Selective Collection
- Some data collection may not be required in cases where selective safety data is justified. You may be able to collect non-serious adverse events, various types of laboratory monitoring, physical examinations and vital sign data, or changes in concomitant therapies at a reduced frequency.
- Benefit-Risk Considerations for Selective Safety Data Collection
- Non-serious adverse events can affect the benefit-risk profile of a drug depending on the indication and patient characteristics. When a drug is sufficiently characterized in a patient population with severe disease, comprehensive safety data collection should still be conducted in a patient population with less severe disease to ensure that the benefits outweigh the risks.
- Early Consultation with Regulatory Authorities
- Considerations include whether the safety profile of a drug is sufficiently characterized to justify selective safety data collection and the specifics of the planned methods of implementation.
- Situations Where Selective Safety Data Collection May Be Considered
- Selective safety data collection may be appropriate for clinical trials to support a new indication of an approved drug or intended to expand the label information of an approved drug, safety trials designed to further investigate potential safety concerns, or clinical trials designed to provide additional evidence of efficacy – all where the safety profile of the drug has been well characterized.
There is also information on practical considerations for implementations of selective safety data collection with examples of the different methods that can be applied. Finally, the guidance does not impact the reporting requirements to regulatory authorities and should be used along with other ICH guidance and regulations.
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