Germany as a study location needs a trend reversal

29.11.2022 11:48

Germany is falling behind as a location for clinical drug trials. According to a new survey by the vfa, Germany only ranked 6th worldwide in 2021 (2020: 4th place) for studies initiated by pharmaceutical companies. Until 2016, Germany was still number 2 in the world.

Spain shows that things can be done differently: This country has become the most important location for studies by pharmaceutical companies after the USA and China. It would be beneficial for Germany to follow this example. Doctors involved in clinical studies can learn the medicine of tomorrow. Sick people receive additional opportunities and particularly intensive care. Companies, on the other hand, make faster progress with therapy development when German clinics also participate.

A trend reversal requires changes in various areas. The most important thing is a nationwide harmonization of data protection for studies and faster contract negotiations between medical institutions and pharmaceutical companies. In order to make contract negotiations easier, vfa and German University Medicine have put together model contract clauses as a suggestion for the design of common parts of the contract. Such clauses are part of Spain's success in higher education. Their use is binding there – unlike in Germany.

Country comparison for 2021

The vfa survey is based on the international study register Clinicaltrials.gov. The number of studies initiated by pharmaceutical companies in 2021 that clinics or practices in a country were involved in was counted. A multinational study was counted for each participating country. Only interventional studies (technically “clinical trials”) with medications were recorded, no registry studies or application observations. The TOP 8 countries are here:

• USA: 2,749 studies
• China: 1,139 studies
• Spain: 682 studies
• UK: 615 studies
• Canada: 605 studies
• Germany: 589 studies
• France: 549 studies
• Australia: 542 studies

Understand the problem

The vfa explains why it has become so difficult to carry out clinical studies in Germany in a new web offering in scrollytelling format www.vfa.de/scrollytelling-klinische-studien. Here he also addresses opportunities for improvement.

Disease areas

The 589 studies in which German medical institutions took part in 2021 concern more than 230 different diseases. This makes it clear how broad the pharmaceutical industry's innovation efforts are. In 2021, the focus was particularly often on the treatment of various cancers (166 studies), immunological diseases (116 studies) and infectious diseases (45 studies, 17 of which were on Covid-19). The immunological diseases included asthma, Crohn's disease and atopic dermatitis.

Studies and development phases

The testing of drugs in clinical trials takes place in four phases. Almost half of the 589 clinical studies with German participation belonged to phase III, i.e. the last major test of a drug before its approval (or approval extension to a new area of application). Here is an overview of the distribution of the 589 studies across the phases:

• Phase I (testing with a few healthy people): 13 %
• Phase II (testing with a few sick people): 36 %
• Phase III (testing with many sick people): 46 %
• Phase IV (testing with sick people after approval): 5 %