Non-Interventional Post-Authorization Safety Studies (NI-PASS) are a type of post-marketing study conducted after a medicine has been authorized for use. These studies are designed to gather additional information on the safety and, in some cases, the effectiveness of a drug under real-world conditions. They differ from interventional clinical trials in several key aspects.
Key Characteristics of NI-PASS:
- Non-Interventional in Nature:
- In NI-PASS, the medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorization.
- The assignment of the patient to a particular therapeutic strategy is not decided in advance by a study protocol but falls within current practice.
- Observational Study Design:
- These studies typically have an observational design. This means that the researchers do not intervene in the treatment regimen but rather observe and record data based on how the medicine is used in routine clinical practice.
- Objective:
- The primary objective is often to evaluate the safety and risk-benefit profile of a drug.
- These studies may provide valuable information on rare or long-term adverse effects that were not apparent in pre-authorization clinical trials.
- Patient Population:
- NI-PASS generally involves a broader patient population, including sub-groups of patients who might have been excluded from pre-authorization clinical trials (like pregnant women, elderly patients, or those with comorbid conditions).
- Data Sources:
- Data for these studies can be collected from a variety of sources, including patient registries, electronic health records, or insurance claim databases.
- Data collection is often less intensive compared to interventional trials.
Regulatory Aspect:
- In the European Union, NI-PASS are often a condition of the marketing authorization granted by regulatory authorities like the European Medicines Agency (EMA). They are part of the risk management plan for a medicine.
- The studies must comply with legal and ethical standards, including data protection laws and informed consent requirements, where applicable.
Importance and Use:
- Post-Market Surveillance: NI-PASS are crucial for the ongoing assessment of the safety profile of medicines once they are used in the general population.
- Risk Management: They can identify previously unrecognized adverse reactions or changes in the frequency of known adverse reactions.
- Informing Clinical Practice: Results from these studies can lead to changes in product labeling or prescribing information and can inform healthcare providers about the optimal use of the medicine.
In summary, NI-PASS play a vital role in the pharmacovigilance system, complementing data from pre-market clinical trials and contributing to the understanding of the long-term safety and effectiveness of medicines in the general population.