Participants in clinical trials as patients are not always able to assume that they themselves will benefit from the results. In fact, case studies are often conducted with the goal of reaching new findings that will benefit future patients. To ensure this, however, it is necessary to publish the results of the study in full and as soon as possible. Only in this way can the findings be used for patient care and to develop innovative therapies.
Researchers at the Berlin Institute of Health and their colleagues from Hannover and Freiburg studied 2,000 clinical trials, which were kept in a public register and completed between 2009 and 2013. The number of trials included 1,200 that are referred to as “Investigator Initiated Trials”, in which the researchers themselves carry the main responsibility for the publication of the results as opposed to a drug manufacturer. “Of these 1,200 studies, only 39 percent, far less than half, were released within a period of two years after completion,” says Daniel Strech, Head of the Translational Bioethics working group at BIH QUEST Center for Transforming Biomedical Research, who led the study. The two-year period corresponds to the definition of “prompt release” by the World Health Organization (WHO). Among all 36 German medical faculties studied, this ratio varied from 20 to 64 percent. “Of course, more study results are published within five years after completion, an average of 67 percent ranging between 43 to 90,” Strech adds. His colleague Dr. Susanne Wieschowski of the Hannover Medical School, who has taken over a large part of the research work, explained the discrepancy: “It can sometimes take several months to publish results in peer-reviewed journals, and often authors have to approach a number of different journals. It is still worthwhile to publish the results as a scientific paper five years after completion of the study, and this is to be commended but it should not be the rule.”
“Thus far, metrics to determine the quality and excellence of medical faculties have been primarily geared towards the amount of research funds they have raised, the number of studies carried out, or the so-called impact factor of publications,” says Prof. Ulrich Dirnagl, who is also a member of the project and the founding director of the QUEST Center at the Berlin Institute of Health. Prof. Dirnagl added: “We need alternative, complementary measures that present a better picture of the ‘value’ medical research has for society and science. This new website provides for the first time the figures on “timely release” from all German faculties to anyone interested. “Each visitor to the website can adjust the parameters for timely publication of key figures according to their own interests,” explains Dr. Nico Riedel, data scientist at the QUEST Center, who set up the website. “Those responsible for managing research at the medical faculties can use this information to evaluate their current strategies for promoting timely publication of results and to optimize them as needed,” explains Strech.
“As it can take time to publish results in scientific journals, while in contrast timely publication is crucial for patient care and research, it would be important to see the results of completed studies in the form of a summary report wherever the trial is registered for publication,” adds Jörg Meerpohl, cooperation partner in the project and Director of the Institute of Evidence in Medicine at the Medical Center of the University of Freiburg. The WHO as well as European legislation on clinical research call for these summary reports to be published within twelve months after the completion of the study. The IntoValue website shows there is an urgent need for improvement among all medical faculties in Germany. On average, only two percent of all studies conducted under academic guidance currently reach this figure. “The pharmaceutical companies conducting research as well as some British universities score much better in this metric. This was also shown in the recently published EU TrialsTracker,” commented Dirnagl.
“Our website also indicates a promising trend that the figures for timely publication improve from year to year,” says Strech. “This shows that we’ve created our website at just the right time. Many medical schools recognize the need to optimize the value of their research. The German Association of Medical Faculties (Medizinischer Fakultätentag), also assists us as an important discussion partner in developing strategies for promoting responsible research.”
Prof. Axel Radlach Pries, Chairman (ad interim) of the Berlin Institute of Health (BIH) and Dean of the Charité - Universitätsmedizin Berlin, welcomed the website project: “The information it provides will help us to promote the timely publication of studies. We are currently setting up a trial registry which will include all clinical trials conducted at Charité. In this sense, cooperating with the QUEST Center (BIH) will make it possible to verify which clinical trials have been recorded in public registers and which studies published their results within a specific period of time.”
The website can be accessed at http://s-quest.bihealth.org/intovalue/. Additional information has been published in a preprint of a scientific article at https://www.biorxiv.org/content/early/2018/11/18/467746 and within the Open Science Framework at https://osf.io/fh426/. For information on the EU TrialsTracker, go to https://eu.trialstracker.net/.
In May 2019, the QUEST Center will start a new project funded by the German Federal Ministry of Education and Research (BMBF) which in addition to updating the figures on timely publication will also focus on figures on other topics in medical research such as prospective registration of study protocols and open science.