Feb 26 • 14:09 UTC 🇧🇷 Brazil Folha (PT)

Research on new medications, such as polylaminin, must follow strict international rules

The development of new medications, including polylaminin, requires adherence to strict international guidelines, particularly in clinical trials that involve control groups to assess efficacy and safety.

The article discusses the rigorous international standards governing the development of new medications, highlighting the significance of clinical trials which are conducted in multiple phases. In the later stages of these trials, control groups are utilized to draw comparisons, which help establish the cause-and-effect relationship of the experimental drug. Control groups consist of patients who receive either a placebo or standard treatment rather than the medication being tested, enabling researchers to discern if the observed outcomes are due to the new treatment or can be attributed to other factors.

This model of research, seen as the gold standard for demonstrating the effectiveness and safety of new therapies, has evolved as part of a global consensus on drug testing that has been refined since the 20th century. The reliance on control groups in clinical trials ensures that results are robust and scientifically valid, which is crucial for gaining approval from regulatory bodies and for ensuring patient safety.

The recent debate, sparked by researcher Tatiana Coelho de Sampaio's comments regarding this comparison stage, emphasizes the importance of adhering to these established protocols in the pursuit of medical advancements. The ramifications of this discourse are significant as they can influence future guidelines and the integrity of clinical studies.

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