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Significant NIH changes in clinical research

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Earlier this year, the National Institute of Health (NIH) has modified its biomedical research funding policy. Its objective is to achieve transparency, accuracy and repeatability in clinical research. Although in principle it only affects US research, it is assumed that the trend will expand.

The debate has long existed and NIH has already decided to take steps to ensure transparency in its investigations. The research funded by the NIH must meet stricter requirements than so far: one of the novelties is that all the research results should be published, avoid the selective publication of the results and not hide the negative results. On the other hand, the clinical protocols to be used must be previously registered. The objective of this measure is to ensure that these trials are well designed and have sufficient statistical value to answer the research question. In addition, when the results are later to be published in a scientific journal, clinical trials cannot be redesigned based on what it is appropriate to show the researchers.

NIH has created Clinical Trials.gov to register clinical trials and collect their results. According to NIH, both measures meet the philosophical objectives of open science and will help combat the current crisis of the repeatability of science. According to NIH, academic and social pressures push for bad science, because journals want to publish spectacular and positive conclusions. Among other reasons, it is estimated that between a third and a half of clinical investigations do not publish the results properly, and one of the main reasons is that they do not publish the negative results.

These measures will only be taken in research defined as clinical trials, but NIH has modified its definition. From now on, the term clinical trial will include any research carried out with humans, as well as those that have so far been considered as basic research and that investigate human behavior. The World Health Organization has been betting for years on a broad definition of health that includes physical, mental and social aspects. NIH has also endorsed the definition. Only purely non-participatory observational research will be excluded from this definition.

Finally, studies requiring experimental human participation will ensure that variables such as gender, race, ethnicity and age are taken into account. Moreover, researchers should be trained in good clinical practices every three years to ensure, among others, the rights, safety and confidentiality of participants. According to NIH, people involved in research acquire known and unknown risks for science to advance understanding of health and disease.

Although some of the scientific community has raised dust, the measures are moving forward. It remains to be seen how all this will influence Europe and if similar measures are also adopted here that seek transparency in clinical trials.