Featured Lendület (Momentum) Researcher: Szimonetta Lohner
In medical research, it is vitally important that each study is conducted in accordance with international professional recommendations and expectations, that the results are accessible to all, and that the lessons of proven discoveries are transferred into clinical practice as soon as possible. However, these conditions are not always met. Szimonetta Lohner, Associate Professor at the Institute of Public Health Medicine at the University of Pécs, and her research group, established under the Momentum Programme, is investigating the practice of medical research to achieve these goals.
The main objective of the MTA-PTE Momentum Evidence in Medicine Research Group is to ensure that decisions in health care – whether prevention or therapy – are always based on accurate information, and that medical research supports these decisions in an optimal way. In health care, information comes from clinical trials, which is why clinical trials are at the heart of the research team’s investigations. It is important that clinical trials follow guidelines: they use appropriate methodology to answer questions that are relevant to patients, and their results are always made available in full. After all, evidence syntheses and medical guidelines are based on published data.
Szimonetta LohnerDetecting the potential for error
“Unfortunately, we see that the flow of information from planning to decision is a very sensitive process with a lot of room for error. Such errors distort the information available to decision makers and will affect the decisions they make about health. If a health professional makes a decision on the basis of distorted information, in extreme cases it may mean that the patient does not receive the optimal treatment for themselves,” says Lohner, Associate Professor at the Institute of Public Health Medicine, University of Pécs, and Research Fellow at Cochrane Hungary.
In other words, the research team will examine the process of designing and conducting clinical trials and how they are incorporated into medical decisions.
Its aim is to identify key areas of error and make recommendations to help clinical research in supporting health-related decision-making more effectively.
Although there are different guidelines for clinical trial design, according to the research group leader, practice does not reflect that they work perfectly. “If everyone did everything by the book, we wouldn’t be having this conversation, but unfortunately that’s not what’s happening. We will explore where researchers are deviating from the guidelines, what the reasons are and how the process can be improved.”
An overview of clinical research in the country
The research group plans to conduct research both international research and, above all, research that is important for Hungary. They want to get a comprehensive picture of what clinical research is going on in Hungary and how it is being conducted. At present, there is no database available that would give a clear picture. They are trying to assess in which fields and with what methodology research is being carried out, what proportion of clinical research is initiated by academia, and what role industry is playing, as well as the intensity of national and international collaborations and how these factors are affecting the quality of research and subsequent publication characteristics.
They will examine the extent of grey literature in Hungary. Grey literature refers to research whose results do not appear in electronic databases and are therefore not made available internationally to those who produce systematic summaries or evidence-based medical professional guidelines. In other words, grey literature is missing from international knowledge. They will explore the extent to which Hungarian researchers generate grey literature, and whether manual searches (when results not included in electronic databases can only be found by traditional searches of print journals) are necessary. “Through our research, we will determine the extent to which grey literature exists and the areas of expertise where Hungarian research needs to be made visible at the international level.”
The question arises as to whether all researchers want their negative results to see the light of day. But the research group leader says this is the wrong approach.
“A negative result is not a failure, but information that the idea did not work or the intervention was not effective.
In evidence-based medicine, vested interests should not determine whether something appears or not. This is about people, about the patients who will or will not receive a particular therapy, and obviously this is equally important information if something doesn’t work.”
A good example of this problem was the case of hydroxychloroquine, which was suggested early in the Covid-19 epidemic to be effective against coronavirus, and so a number of clinical trials were conducted on the issue. Following the publication of the research results, Cochrane carried out a systematic review, which made it clear that there was no difference between patients treated and not treated with hydroxychloroquine in terms of the hard endpoint that is mortality, and therefore it was ineffective. If these negative results had not been published, patients might have continued receiving the drug, which otherwise had no beneficial effect for them, until the end of the pandemic.
Data and analysis
As part of its international research, the research team intends to focus on so-called non-regulated interventions. Based on regulation, two groups of clinical research can be distinguished. One area of the research investigates the effects of interventions (such as medication, biological medicinal products, or interventions with medical devices) that are strictly controlled by the authorities, while the other area consists of non-regulated interventions. These include dietary interventions, surgical interventions, behavioural and lifestyle therapies and exercise programmes.
“My previous research has shown that there is a significant difference between the two areas of studies in many respects: the quality of the protocol and, later, the differences in publication processes,” says Lohner. “We would like to create an internationally representative database of clinical trial protocols published in indexed journals, with the help of which we can identify the quality of protocols and publication characteristics of studies investigating the effects of regulated and non-regulated interventions.”
The research team will focus on the evaluation of data from patients.
When a patient goes to see a doctor, they will not ask: “Doctor, how much will my lab values change if I have this treatment?”, but whether their quality of life will change, whether they will have less pain, and whether they will be able to do certain activities better. These are relevant questions for patients, so they are also important for clinical trials. However, until now, research has not made sufficient use of data from these patients. The Momentum group wants to make progress in this area as well.