Iis a drug or procedure better than a placebo? What is the best therapy, what side effects are there? Studies on this are essential for medicine – they can make it possible to save lives or alleviate the consequences of diseases. Clinical studies are often very complex, can cost several million euros, and they are carried out on human subjects. Ethical standards such as the World Medical Association’s Declaration of Helsinki therefore stipulate that the results must be published. Studies should also be registered before they begin, so that information about them is public – and researchers, clinics and companies cannot simply let them disappear. “Negative and inconclusive results, like positive ones, must be published or otherwise made publicly available,” the declaration states – with details of funding sources, institutional affiliations and conflicts of interest.
Transparency of intransparency
Recently, it has been repeatedly reported that many results are not published at all or very late. In drug trials, this can even break the law, with fines of $10,000 a day possible in the US. A team from the Berlin Institute of Health (BIH), based at the Charité, is now presenting a web-based analysis with data on studies in which 35 university hospitals are involved in the specialist magazine “PLOS Medicine” – it has been on quest-cttd.bihealth since Tuesday .org available. This includes studies that were completed between 2009 and 2017. “The universities themselves don’t know how things look with them across all studies,” says Daniel Strech from the BIH. These are increasingly sensitized after realizing that they themselves sometimes do not fulfill legal obligations; Medical companies have been significantly better here for a long time.
As the researchers write, transparency increases over the years examined. “We didn’t find anything where there was a negative development,” says Strech. According to the analysis, the university hospitals in Würzburg, Rostock and Saarland lead in terms of the proportion of published results within five years of the end of the study. Those in Dresden, Erlangen, Halle and Aachen ranked lower, where publications were only available for around 50 to 60 percent of the studies. A spokesman for the latter says questions about transparency are justified: the medical faculty encourages all investigators to publish results, and the ethics committee also reminds them of this. Some publications required a long time, some studies would have to be stopped because they could not recruit enough subjects. According to the University of Erlangen-Nuremberg, some study results were published later.
There is the “goal of publication”
Publication is a scientific and ethical imperative, explains a spokesman for the TU Dresden. All 18 clinical trials currently running have the “goal of publication”. This takes time. Many studies are initially not accepted, and then new ways of publication are sought. For studies on medicines and medical devices, where the standards are stricter, there are work instructions, for example on how to create reports. The local ethics committee also asks researchers to submit a report of the results.
For doctors, compliance with the Declaration of Helsinki is part of professional law – he has “never heard of sanctions being imposed,” says Strech. As an incentive, his team wants to automatically create certificates for studies that state which criteria are met. He also calls for results to be made public via Open Access. “These are studies that directly influence what routine care looks like.” Observational or animal studies, which usually have no registration or publication culture, look even worse than clinical studies.