Clinical trials

NRW: An excellent location for clinical research

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Definition

A clinical trial systematically and prospectively investigates the effect and value of an intervention in humans (intervention study) or systematically observes the influence of certain factors (observational study) under defined conditions. An intervention in this context can be, for example, the use of a treatment method, a drug or a medical device.

Clinical trials on pharmaceuticals

Clinical trials require approval and are subject to the German Medicines Act (AMG). A clinical trial in humans is “any investigation conducted in humans intended to explore or demonstrate clinical or pharmacological effects of drugs, or to detect adverse reactions, or to study absorption, distribution, metabolism, or excretion, with the aim of ascertaining the safety or efficacy of drugs.” (AMG, §4, 23)

A non-interventional trial under the AMG is “a study in which findings from the treatment of individuals with drugs are analyzed using epidemiological methods; in this context, the treatment, including diagnosis and monitoring, does not follow a pre-specified protocol, but follows medical practice alone.” (AMG, §4, 23)

In principle, a distinction can also be made between approval-driven and science-driven studies. Science-driven trials (investigator-initiated trials, IIT) are initiated by researchers themselves and usually require third-party funding. IITs are predominantly subject to the same legal and regulatory requirements as studies in the pharmaceutical industry.

Ethics Committees

A clinical trial may only be conducted if sufficient data (evidence) are available for safe conduct and a positive vote has been obtained from the responsible ethics committee. A list of registered ethics committees of the BfArM can be found here (German PDF).

Clinical trial registration

The Declaration of Helsinki requires that the results of each clinical trial be published promptly (i.e. within 24 months) after its completion. The most important results should be available after 12 months. Clinical trial results are often published in peer-reviewed journals. In addition, study results may be published in a variety of publicly available clinical trial registries.

The publication of study results in clinical trial registries is mandatory. In Germany, the publication of clinical trial results in registers is carried out by the competent higher federal authorities (BfArM, PEI), at European level by the EMA. This obligation does not currently exist for clinical trials of medical devices. However, corresponding EU regulations have created the legal basis for transmitting the results of clinical trials to corresponding study registries. For clinical trials with medical devices, this will be mandatory from May 2020; for drug trials, this depends on the availability of a corresponding European database structure, the completion of which has already been delayed by several years.

Clinical trials register

The EU Clinical Trials Register (EUCTR), which uses the EudraCT database, is only one of a number of WHO-certified registries. Other possible registries are the German Clinical Trials Registry (DRKS) and the American ClinicalTrials.gov. Clinical trials funded by the DFG or the BMBF already have to be registered in a WHO-certified registry. In Germany, there is also the PharmNet.Bund registry, which is maintained exclusively by the competent higher federal authorities (BfArM, PEI).

Participation and patient involvement

Patient participation in research does not only mean that those affected participate as test subjects in clinical studies. Rather, it means that those affected are involved in all phases of research. Both patients and researchers can benefit from this. Ultimately, this can lead to an improvement in the quality of a clinical trial.

However, the willingness of patients or subjects to participate is also essential for clinical trials to be conducted. Comprehensive information about all study contents is necessary so that subjects can make an informed decision. The ECRAN project, for example, has set itself the goal of explaining medical research in a comprehensible way and providing the most important information about participation in clinical trials.