Non-interventional study

Non-interventional studies are studies in which no study-related intervention is made on study participants.

Classification of clinical studies

Intervention study

Observational study

comparative
groups

Randomized
controlled study

non-randomized
controlled
study

Cross-sectional
study

properties

Non-interventional studies or tests are defined in the Medicines Act (AMG) as investigations in the context of which "findings from the treatment of people with medicinal products are analyzed using epidemiological methods", with the use of the medicinal products being carried out as part of the doctor's therapeutic work (§ 4 paragraph 23 sentence 3 AMG).

The AMG distinguishes between

Application observations (Section 67 (6) AMG) and
non-interventional safety tests (§ 63f AMG)

According to the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute, the non-interventional character of a study is characterized by the following points:

Treatment, diagnosis and monitoring correspond to normal medical treatment practice; no additional diagnostic or monitoring procedures are used in the patient.
The decision on the drug prescription is made regardless of inclusion in the test.
The treatment does not follow a fixed test plan, but only the medical practice (using an observation plan); there is also no randomization.
The treatment is carried out in accordance with the authorization or approval of the drug, i. H. no off-label treatment.

In the broader sense, non-interventional studies include all forms of observational studies that are characterized by the fact that, unlike experimental studies, scientists do not intervene in the application of medical measures; on the one hand, properties and behavior (exposure) of the participants are registered and on the other hand, significant health events were recorded. The participants are observed with respect to defined variables in their normal lifestyle, which is not influenced by the study.

The main forms are:

Observation of use (AWB) and non-interventional safety tests, which are mostly carried out by manufacturers for their approved drugs as part of a phase IV study.

Cohort studies in which a defined group of exposed or non-exposed persons (the cohort) is examined prospectively with regard to the probability of a predefined event occurring. The exposure can e.g. B. a drug or be and the event an adverse drug reaction (ADR) or an illness.

Case-control studies in which the starting point is an event that has already occurred (e.g. lung cancer) and looking backwards (retrospectively) looking for exposures (risk factors) in which sick and non-sick people differ (here e.g. B. Tobacco Consumption).

Cross-sectional studies in which data are collected once at a specific point in time.

Legal basis

For non-interventional drug studies, there is an obligation to notify the higher federal authority ( Federal Institute for Drugs and Medical Devices or Paul Ehrlich Institute ), the National Association of Statutory Health Insurance Physicians , the National Association of Health Insurance Funds and the Association of Private Health Insurance . V. (Section 67 (6) AMG).

literature

Federal Institute for Drugs and Medical Devices . Non-interventional exams. Retrieved June 27, 2020.
D. Mishra, J. Vora: Non interventional drug studies in oncology: Why we need them? In: Perspectives in clinical research. Volume 1, Number 4, October 2010, pp. 128-133, ISSN 2229-5488 . doi: 10.4103 / 2229-3485.71770 . PMID 21350727 . PMC 3043359 (free full text).

Individual evidence

↑ Federal Institute for Drugs and Medical Devices: Glossary. Retrieved June 27, 2020 .
↑ § 4 paragraph 23 sentence 3 AMG on gesetze-im-internet.de
↑ Section 67 (6) AMG on gesetze-im-internet.de
↑ § 63f AMG on gesetze-im-internet.de
↑ Federal Institute for Drugs and Medical Devices (BfArM), Paul-Ehrlich-Institut (PEI) .: Joint recommendations of the Federal Institute for Drugs and Medical Devices and the Paul-Ehrlich-Institut on observational studies in accordance with Section 67 (6) of the German Medicines Act and on the notification of non-interventional safety tests Section 63f Medicines Act of December 20, 2019. Retrieved June 27, 2020 .
^ Institute for Quality and Efficiency in Health Care .: Glossary of terms from the health care system. Retrieved June 27, 2020 .
^ RD Bernabe, GJ van Thiel, JJ van Delden, JA Raaijmakers: Informed consent and phase IV non-interventional drug research. In: Current medical research and opinion. Volume 27, Number 3, March 2011, pp. 513-518, ISSN 1473-4877 . doi: 10.1185 / 03007995.2010.546393 . PMID 21208152 .

[1] Federal Institute for Drugs and Medical Devices: Glossary. Retrieved June 27, 2020 .

[2] § 4 paragraph 23 sentence 3 AMG on gesetze-im-internet.de

[3] Section 67 (6) AMG on gesetze-im-internet.de

[4] § 63f AMG on gesetze-im-internet.de

[5] Federal Institute for Drugs and Medical Devices (BfArM), Paul-Ehrlich-Institut (PEI) .: Joint recommendations of the Federal Institute for Drugs and Medical Devices and the Paul-Ehrlich-Institut on observational studies in accordance with Section 67 (6) of the German Medicines Act and on the notification of non-interventional safety tests Section 63f Medicines Act of December 20, 2019. Retrieved June 27, 2020 .

[6] Institute for Quality and Efficiency in Health Care .: Glossary of terms from the health care system. Retrieved June 27, 2020 .

[7] RD Bernabe, GJ van Thiel, JJ van Delden, JA Raaijmakers: Informed consent and phase IV non-interventional drug research. In: Current medical research and opinion. Volume 27, Number 3, March 2011, pp. 513-518, ISSN 1473-4877 . doi: 10.1185 / 03007995.2010.546393 . PMID 21208152 .