Aborted clinical studies: Miserable testimony for the German corona

In order to end the corona pandemic and learn lessons from it for the future, solid scientific studies are essential.

All the more so since the many pseudoscientific contributions cause considerable confusion and undermine the evidence-based knowledge gain.

The prerequisites for scientific studies are also ideal, at least in terms of the number of potential test subjects.

In Germany alone, more than four million people have been proven to be infected with Sars-CoV-2 and more than 170,000 of those infected have been treated in hospital.

But while clinical research on Corona is making progress in other nations, it is leading a wallflower existence in this country. Particularly inglorious: During the entire first year of the pandemic, several controlled studies with patients were initiated in this country, but only a minority of them successfully continued or completed. Researchers from Switzerland and Germany came to this unflattering result after a detailed analysis of the relevant study databases.

As the team led by Lars Hemkens from the Department of Clinical Research at the University Hospital Basel and the Berlin Institute of Health reported in an as yet unapproved article in the preprint journal F1000Research, around 3000 corona studies with evidence-based protocols were registered worldwide in 2020. Among them were 65 that were to be carried out in Germany or with German participation. All 65 research projects aimed to find a new therapy or vaccine against Covid-19 disease. In contrast, there were no studies on non-pharmacological issues, such as how the virus spreads and how helpful such drastic regulations as exit restrictions are. Institutions such as schools, kindergartens and nursing homes were also not taken into account in the studies.

As far as the number of test subjects is concerned, the German centers targeted an average of 106 test subjects per study, but were only able to include an average of 15 participants, which is less than 14 percent of the originally planned number. In addition, eleven of the 65 studies have still not started or will no longer start and only 14 have been completed. Against this background, it is hardly surprising that in this country only about one in one hundred inpatient corona patients was or is involved in a relevant therapy study.

According to the authors, in Great Britain it should be one in six, so many times more. The reason for this is the long-established, efficient study infrastructure, write Hemkens and his colleagues. The recovery study - a British project in which various therapy options are tested in Covid 19 patients - was planned within two days. After nine days, those responsible would have won the first test subject and have now included more than 10,000 participants. After two months of study, the first beneficial therapy was discovered.

Why only comparatively few corona studies are carried out in Germany and why only a fraction of them reach the intended number of patients or the finish line has not been determined. At the same time, the authors of the analysis find it difficult to understand why non-pharmacological measures to contain the corona pandemic receive so little attention in this country. In any case, it does not seem to be due to the lack of interest on the part of the researchers.

This is supported by the experience of the physicist and aerosol researcher Gerhard Scheuch, who after many years of research at the Helmholtz Center in Munich is now doing aerosol research as a private individual and advising the Robert Koch Institute in this regard. “Together with various universities, I recently applied to the Federal Ministry of Health for two studies on the subject of aerosols. One was about the early identification of corona infected people in old people's homes and the other about the question of whether children can also be super spreaders and how many aerosol particles they exhale. Unfortunately, both studies were rejected, ”says Scheuch. However, they have now initiated the child study. They managed to raise enough donations for it.The federal government, i.e. taxpayers, has so far provided more than one and a half billion euros for publicly financed corona research.