Medical Research: Secret Studies | tagesschau.de

Many medical studies still remain unpublished for years. This is shown by an evaluation by scientists at the Berlin Charité. Physicians criticize that this endangers patients and wastes funds.

Between 2011 and 2017, almost 300 children with attention deficit disorder (ADHD) took part in a study at the University Hospital in Mainz. Her parents had agreed that doctors would test whether polyunsaturated fatty acids in combination with zinc and magnesium would improve children’s health. The study has now ended, but what came out of it is not known. The results are not published.

Health scientist Jörg Schaaber is outraged: “People always put their health at risk to a certain extent by taking part in a study,” he says. “I don’t think it’s morally justifiable if you don’t give back this commitment that the test subjects give to the general public.”

Upon request, the University Hospital Mainz stated that the study mentioned was still being evaluated “due to its complex survey pattern”. It was formally completed six years ago, as if from a Entry in the central register of studies is evident. Irrespective of this, the results would not have to be published at all, writes the university clinic on request. Because this specific study is subject “neither to the regulations of the Medicines Act nor the Medical Devices Act”.

The Mainz ADHD study in children is one of a total of 1694 studies in which no results were published at least two years after completion. This was discovered by researchers from the Berlin Institute of Health at the Charité, who published their results online in the journal “PLOS Medicine”. “In total, there were almost 3,000 studies between 2009 and 2017, and the results of only 41 percent became known in the two years after the end of the study,” reports author Delwen Franzen.

At the same time, Franzen and her colleagues have a freely accessible one Overview page (“dashboard”) put on the webin which you can look up the number of unpublished studies for each university hospital in Germany.

Big differences depending on the university

According to this, some universities come up with 40 percent unpublished study results two years after graduation, other universities with 80 percent. “For the first time, we are giving universities the opportunity to find out for themselves how good their publication rate is,” says Daniel Strech, one of the authors of the study. “This may not be pleasant for the universities, but it leads to improvements.”

But isn’t it asking too much to expect the results to be published two years after the completion of a study? “By no means,” says Strech. The World Health Organization (WHO) requires at least a brief publication of the results after one year and then a specialist publication after two years. But even after five years, no results can be found in around 30 percent of the studies, according to Franzen and Strech.

reasons vary

The reasons for the non-publication are manifold, says Stefan Sauerland from the Institute for Quality and Efficiency in Health Care (IQWiG). “Some consider their results to be boring or disappointing, but that is by no means a reason not to publish them,” says Sauerland.

If disappointing results are not published, patients may continue to be treated with harmful therapies. Or other researchers at other universities do the same studies again because they don’t know that a question has already been investigated before. “That would also be a pointless waste of research funds,” says Sauerland.

Drug trial pressures

The medical scientist Till Bruckner from Great Britain, who with his organization TranspariMED has been drawing attention to the inadequacy of unpublished study results for years, sees improvements in one area at least: in drug studies. The Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI) are now actively asking those responsible for the study where the results are if they are not published. As a result, more than 90 percent of the results of drug tests are now published promptly.

Many studies are exempt from publication requirements

The problem, however, is that only for drug studies there is also a legal obligation to publish results. However, this does not apply to studies on dietary supplements, as in the case of the ADHD study in Mainz. Surgical studies, psychotherapy studies, dental studies or nursing studies are also excluded, says IQWiG researcher Sauerland: “In the year before last we were only able to evaluate a new treatment method for brain metastases to a limited extent because we saw that it was examined in a study, but the academic research group was unwilling or unable to publish the study results.”

According to the health scientist Jörg Schaaber from the Buko Pharma campaign, there is still “an immense publication gap”, especially in the case of studies on medical products and medical procedures, but also on older medicines.

Stefan Sauerland from IQWiG therefore calls for the state to set some simple rules. So far, every human study has had to be approved by an ethics committee. The ethics committees could report every approved application to the BfArM, and the BfArM could then ask the responsible researcher about the result one year after the end of a study. And for those who don’t publish study results, the ethics committee could reject future study applications. “That would be a relatively simple but effective method,” says Sauerland.