Observational study

Observational studies (AWBs) are studies designed to gather evidence on the use of authorised or registered medicinal products or medical devices.

Observational studies are subject to strict quality and transparency standards, including consultation with an ethics committee and publication of the results

Observational studies are non-interventional trials within the meaning of Section 4 (23) sentence 3 of the German Medicines Act (AMG).

Observational studies are not subject to authorisation, but are notified. In accordance with Section 67 (6) (10) AMG, the competent higher federal authority makes the notifications and final reports submitted to it available to the public on the Internet.

Observational studies are often initiated by pharmaceutical companies, but can also be ordered by authorities. The participating doctors record medical histories and application results, which are then analysed by the manufacturer. Patients must be informed about their participation and give their consent.

The knowledge gained from observational studies is sometimes viewed critically, as they often do not fulfil the same strict methodological requirements as clinical studies. There are concerns regarding the practice of fees, as high remuneration could potentially incentivise doctors to prescribe.

Regulation (EU) 2017/745 on medical devices (EU MDR 2017/745) also regulates post-market clinical follow-up (PMCF, Annex XIV, Article 61) and post-market surveillance (PMS, Article 83) for clinical evaluation (Annex XIV, Article 61) and clinical investigations (Annex XIV, Articles 62-82). The clinical evidence for PMCF and PMS can be obtained via observational studies in compliance with the regulations. They are conducted under real-life conditions without additional diagnostic or therapeutic interventions.

An observation plan defines the course of the study, in contrast to a protocol for interventional studies.

‍Observational studies must be conducted in accordance with the recommendations of scientific and regulatory guidelines, such as the Guidelines for Good Pharmacoepidemiology Practices (GPP) and the Guidelines for Good Epidemiological Practice (GEP).

Observational studies of medicinal products and medical devices are a valuable instrument for collecting data on the safety and effectiveness of products in real-life use. They complement clinical studies and help to obtain a more comprehensive picture of product performance and safety.

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