Transparency for clinical trials
Transparency of study results in a public dashboard
Advertisement
clinical trials are the “backbone of evidence-based medicine”: This is where new drugs and treatments are tested on humans for the first time. The results of such trials are therefore highly relevant. But unfortunately many clinical trial results from German universities are not published at all or are registered too late – and if they are published, the results are often not openly accessible. To change this, scientists at the BIH QUEST Center have developed a publicly accessible dashboard that displays how 35 German universities fare in terms of transparency of the clinical trials they have conducted. A total of some 3,000 clinical trials were evaluated for this purpose.
Symbolic image
Computer-generated image
The scientists have now published their methodology and results – in open access – in the journal PLOS Medicine.
Clinical trials test whether a new procedure or drug is safe, effective, and better than previous therapies. The results of the trials are therefore highly relevant: If a new substance or procedure proves to be better than the standard treatment, it will then usually go through an extensive approval process before entering the market. If this is not the case, the new alternative treatment is often forgotten.
A good quarter of the clinical trials conducted at universities and hospitals in Germany don’t publish any results even many years after the study is completed – despite existing transparency rules such as those in the Declaration of Helsinki, which are morally binding on physicians. As a result, all other scientists and physicians fail to learn whether a particular medical intervention has already been tested or whether a further analysis of the trial results might be worthwhile because it would have revealed benefits for a subgroup of patients.
Daniel Strech, BIH Professor for Translational Bioethics and Deputy Director of the BIH QUEST Center, found this situation unsatisfactory. “Patients have agreed to participate in clinical trials in order to advance science and medicine. We are obligated to them to publish the trial results,” he argues. “But also from an ethical perspective, it is at least problematic not to disclose results of trials that were paid for with taxpayer money.”
Transparency of study results in a public dashboard
Together with his team at the Berlin Institute of Health at Charité (BIH), he decided to address this issue. “We collected information on about 3,000 clinical trials that were listed in one of two established registries and conducted at one of the 35 university medical centers in Germany,” reports Delwen Franzen, a research fellow in Strech’s group and first author of the paper. “We were above all interested in data related to transparency: Did the principal investigator publish the trial results? Was the trial registered before it started? Did the registry indicate that the trial results had been published? Were the results made publicly available?”
A dashboard now presents the results on the various transparency indicators for Germany as a whole as well as for individual universities. “The last few years have shown that public information on clinical trial transparency can have a major impact,” reports Strech. “Another publicly accessible website, created by colleagues at Oxford University, has for three years been providing information on the transparency of drug trials listed in the relevant EU registry. Here Charité fared poorly, landing toward the bottom of the pack. After we discussed this with the Charité Clinical Study Center, and an improvement process was launched there, a marked increase in transparency could be observed: Charité has now risen to the top of the pack, publishing the results of 97 percent of its clinical trials. We were very pleased to see that.”
Transparency as a pillar of evidence-based medicine
This is because, surprisingly, university medical centers themselves often don’t know exactly how many of their clinical trials are transparently registered and published. Nor do the funding agencies know the publication rate of the trials they fund. “We are confident that the information provided by our dashboard will make a difference for the better at all university medical centers,” explains Franzen.
That has also caught the attention of colleagues abroad. A number of European and American colleagues now want to introduce similar dashboards, explains Strech: “During my sabbatical last year at Stanford University, I was able to convince my colleagues there to implement our concept in the U.S. as well,” he says. Strech is convinced that publishing clinical trial results is worthwhile: “Clinical studies are the backbone of evidence-based medicine. And transparency keeps this backbone healthy.”
Original publication
Other news from the department science
Most read news
More news from our other portals
Last viewed contents
Bertelsmann Investments acquires stake in AI-powered Israeli healthcare startup QuantHealth - AI-supported start-up company for clinical trial planning
First synthesis of open-chain N-stereogenic amines achieved - Study enables enantiomerically pure products for drug development.
The spider with the bee venom - New perspectives for the search for active substances against cell-based diseases - Researchers decode the toxin arsenal of the most poisonous native spider species
Is the immune system younger in the morning? - The internal clock of immune cells
Pancreatic cancer forms "synapses" - Pancreatic tumors use neurotransmitters to drive their own growth: Researchers hope to identify drugs that can block this process
A toxin with a useful twist - Their work opens the door to new applications in lab-on-a-chip technologies, biosensors, and artificial cell prototypes
Gene scissors in camouflage mode help in the search for cancer therapies - Overlooked genes for metastasis formation uncovered
Gene modification enables more functional liver cells from stem cells
Bacteria Borrow Viruses to Spread Their Own Defences - Pseudomonas fluorescens exposed to sterile compost filtrate acquired multiple mobile genetic elements carrying anti-phage defence genes
Opening the door to affordable lab-grown beef, cow cells defy aging - A potential game-changer for creating sustainable, ethical meat without the environmental toll of traditional livestock farming
Synthesizing fine chemicals: Technological Advance in Production of Pharmaceuticals
