The bad science that the pandemic brought us

The bad science that the pandemic brought us

In the face of great progress, a significant portion of clinical research has not been of good quality. The reasons relate to an outdated approach to trials, including a lack of collaboration and coordination, along with regulatory hurdles. But there is a model to refer to

(photo: Ulrike Leone via Pixabay) The pandemic has changed the way of doing research, causing a real revolution, both in basic and applied sciences. Human skills, commitment and efforts, including economic ones, have produced successful and impactful results for public health on a global level. We recall, for example, the new vaccines against Covid-19, including those based on new messenger rna technologies. However, there is also a downside, a sort of not just side effect: that in the great mass of research there are several, even not sufficiently accurate. Sometimes these are studies that are disseminated or revised in a hurry or based on limited data but shared with a broad general public, to which this limitation is not explained, or even repeated in duplicates due to the lack of national and international coordination. The ingredients behind the cake of this bad science are many: the huge amount of research produced, the strong pressure and speed required of scientists to find new solutions against the coronavirus, the large sounding board of some researches enhanced by era of the internet.

All these elements open many questions about the present and the future of science, both in the case of new emergencies and for quiet future times. After a careful analysis of the science associated with Covid-19 and the pandemic, several investigations have highlighted the problem, providing concrete examples of the criticalities of emergency scientific research.

Quantity or quality? Better together

A necessary premise concerns the research data at the time of the coronavirus, which has produced a huge amount of publications. Many have left ongoing projects in their research area to devote themselves to the virus. Suffice it to say that by typing the word Covid-19 into the Pubmed scientific database, at the end of April 2021 there are nearly 130,000 studies that cite the topic in various capacities. The race for publication has been underway since the beginning of the pandemic, recalling that already on the date of March 20, 2020 - about a month after the coronavirus arrived and took hold in Italy - there were already thousands of papers always on Pubmed.

If we wanted to use a statistical approach also in this case (the mathematics is not valid only in the context of the pandemic) the statistics would lead us to think that in such a large sample of studies published within a very short there is a percentage of searches, perhaps even a small one, does not reach optimal quality standards. The point is not that there are too many studies, or rather this is not the cause of bad science, but the knots come to a head when to produce more you choose to lower the quality.

The idea that there both a low-quality proportion of studies is supported and argued by an international research group, including McMaster University in Canada, which has carried out an extensive analysis of the criticalities of clinical research, published in The Lancet Global Health. In the amount of work that deals with or cites only the coronavirus, at the beginning of December 2020 there were only 68 publications related to clinical trials on Covid-19 randomized (in which the assignment of participants to groups is random) and peer reviewed, as the authors in Lancet point out, of which a large proportion carried out in China, the first epicenter of the pandemic.

The most studied interventions are treatment with hydroxychloroquine, followed by treatment with lopinavir-ritonavir and remdesivir. The authors note that most of the trials are carried out in the hospital and focus on the critical stages of the disease, while there is still little research on the early stages of Covid-19, on how to prevent the infection from progressing. This is partly linked to the greater difficulty of carrying out studies in the home setting (as was the case, for example, in a study on the use of the corticosteroid budesonide).

If the approach is obsolete

With the pandemic, research has taken on an urgent nature of research, imposed by a completely anomalous situation, a unicuum not only for society but also for science. "The main problem - explained to Wired Edward Mills, co-author of the work, professor of research methods in the medical field at McMaster University in Canada - is the lack of preparation in making quick decisions. Clinical research has been using the same approach more or less constantly for about 70 years ”. So it would be the lack of readiness, rather than haste, that indirectly and involuntarily favored the production of results of dubious quality.

The obsolete approach is compounded by organizational and bureaucratic problems. "The process is slowed down by administrative obstacles", continues the expert, "for example in obtaining funding, in regulatory approvals and in the recruitment of healthcare personnel and patients participating in the trials". But there is also an exception. "The only country that took a different approach was the United Kingdom," Mills explains, "where a research unit to conduct impactful medical studies had already been set up nationwide. The facility was able to move quickly to launch the Recovery and Principle trials. The rest of the world should look to the UK to try to imitate it in the future ”. In short, the bureaucracy in this case would have affected almost everyone.

The first thing to do

To change the situation, a radical intervention should be implemented, to change the approach to clinical research and get closer to the latest British model, according to the expert. This revolution could cost efforts in terms of skills and investments, especially at the beginning, but it would be successful and cost-effective in the long run. "There is a need to create infrastructure to carry out clinical trials in sites or areas that have shown they can conduct useful research or have such a significant disease burden that it makes sense to invest there," Mills remarks. “Building the infrastructure includes engaging the sites, ensuring regulatory approvals have been obtained, that staff are recruited and trained, and that there is lasting funding to do research beyond a single need. With a sufficiently large network of sites, repetition of the same work and duplicate studies are also reduced ".

Successful results in this pandemic, such as the rapid development of safe and effective vaccines, are also reduced. it was actually a milestone of a few, according to the expert. "The vaccine trials were conducted by the larger Contract Research Organizations, which provide support within the pharmaceutical and biotechnology industries," says Mills. “These are structures that have strong networks and a sophisticated patient recruitment mechanism. Very few smaller companies or academic entities can compete with them. Vaccine trials have certainly been a success, but they probably could not have been replicated by structures that are not heavily funded. ”

In short, it is a result of a few, which could be more extensive in the future. "We hope - write the authors in the conclusions of the study on The Lancet Global Health - that the Covid-19 pandemic will become a historic turning point that leads to better coordination and collaboration within the medical research community, but this achievement will first require the consensus of funders and health researchers globally (particularly those in high-income countries) who currently control the design of the studies ".

Reduce waste and increase trust

If it is true that little is better than nothing, there would still be a saving of energy and economic forces if there was more coordination, communication and sharing of data and work between research institutions at national level and possibly on international scale. For example, some of the 68 studies already randomized and peer reviewed as of December 2020 also do not indicate the sample size, which on average is composed of 186 participants. This number indicates the presence of numerous studies based on very small groups of volunteers and from which it is difficult to draw conclusions. Over 100 hydroxychloroquine trials have been launched for Covid-19, as Mills points out. "Organizing and structuring the work in a different way would have made it possible to avoid repetitions of the same tests", adds the expert, "reducing time and resources lost and not feeding the expectations of the participants".

The problem does not concern only the waste of energy and money, but also the loss of trust on the part of people. Volunteers in clinical trials on Covid-19 are generally patients, often hospitalized, who take part in the trial, inevitably taking risks in the face of a possible benefit to their health or in any case an advance in terms of discoveries and knowledge about the coronavirus . When one of these requirements is lacking, the subsequent participation also receives a lower membership. Advances in order to be such, advancements "require collaboration," the authors write in the Lancet, "which includes publishing all data, regardless of the results, and making them available to the scientific research community."

Preprint or peer reviewed?

The criticalities in research concern not only the approach to medical research and the way of creating studies, but also the methods of disseminating the results obtained. With the pandemic, some changes that were already underway were accelerated and became evident, with some negative implications. These include the preview disclosure of the data with the release of the studies in their preprint version prior to correction through the review process by other scientists not involved in the work - peer review.

In the face of the great merit of a more agile peer review and the existence of servers such as biorXiv or medRxiv, which provide preprint versions and allow you to know and share important data on the coronavirus, shortening often very long times, in some cases, however, this process has the diffusion of poor quality data and insufficiently evaluated research is also encouraged, as the authors of the Lancet work underline.

On the scales, once again, there is speed and rigor. We should always try to find the right balance between disseminating knowledge as timely as possible and checking the data: once the validity and correctness have been ascertained, with the same rigor, it is better to publish first.

An example of studies published perhaps too soon and then eliminated concerns the case of two articles, one on pressure drugs, published in the Nejm, and the other on chloroquine and hydroxychloroquine, in Lancet, withdrawn shortly after by the authors. An even different situation is that of predatory journals, non-prestigious journals that exist to obtain financial income from authors at the expense of the peer review process.

Side effects range from a distracting effect, at best. cases, to the waste of considerable resources and damage to health, at worst. And in the age of the internet, in which everyone can speak and disseminate their studies, even recognizing the validity of a data can be difficult, in a moment of collective fragility in which everyone wants answers, as explained by Walter Scheirer, professor of the department of Computational Sciences and Engineering at the University of Notre Dame, author of an article entitled A pandemic of bad science. The scientist draws attention to the need for greater control of both preprint servers and social media, together with the need for only those with specific skills to be able to embark on a certain field and for researchers to be the first to agree to respect the natural ones. and necessary time for quality checks before publishing.

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