Clinical studies are an essential part of developing new drugs and treatments. Without them, it would not be possible to determine the safety and effectiveness of these products for patients. However, clinical studies in children are a complex issue, since the well-being of minors must be considered.
In the scientific community dedicated to carrying out clinical studies in the country, it has raised great interest and concern, since despite being a country with a fairly considerable child population, there are regulations that prevent its process.
The impact of implementing new therapies in the child population is not only reflected in the improvement of children’s health and well-being, but also in a notable increase in income and advances in research. Looking at examples of countries that already carry out these studies, it is evident not only the economic boost derived from early care for children’s health, but also the significant progress in medical knowledge and available therapies. However, beyond financial considerations, it is essential to highlight the ethical reasons that support this practice, underlining society’s commitment to the comprehensive care and development of children.
But why aren’t clinical studies done in children in the country?
- Lack of specific regulations that guide the conduct of clinical studies in children, which creates uncertainty in the community and sponsors, discouraging these types of studies.
- Limited infrastructure, financial and technological resources necessary to carry out clinical studies.
- Lack of participation from society and awareness about the importance of clinical research in children.
- Ethical concern about clinical studies in children since they are considered a vulnerable population; in the country there are laws and regulations that protect children in clinical studies.
Conducting clinical studies in children in Ecuador would have several benefits; it represents an opportunity to improve children’s health in the country by allowing Ecuadorian patients to access innovative medicines before other countries, contributing to advances in pediatric medicine not only in the country but also in other countries. worldwide and generating employment and training opportunities for health professionals.
To begin the development of pediatric clinical studies, it is essential to allow the articulation of a comprehensive research ecosystem. This involves the creation of specialized centers equipped with cutting-edge technology, as well as the establishment of specific regulations that regulate and guarantee the performance of clinical studies in children. The necessary investment encompasses not only financial resources, but also time and efforts to set up an environment that has properly trained personnel and adequate equipment and infrastructure. This approach will not only help boost the quality and effectiveness of pediatric clinical studies, but will also foster an ethical and responsible commitment to research in children.
Countries in the region and the world that do carry out pediatric clinical studies.
In Latin America, there are several countries that carry out clinical studies in children. Among them are Mexico, Brazil, Argentina, Chile and Colombia. These countries have developed regulations and policies that protect children in clinical studies, and have the necessary infrastructure to conduct these trials.
In the world, there are many countries that carry out clinical studies in children. Among them are the United States, Spain, Japan and China. These countries have long experience in conducting clinical studies and have strict regulations and policies that protect children.
Each regulation and policy applied in these countries is aimed at protecting children and obtaining reliable results.
Is pediatric clinical research ethically correct?
It may be correct when due ethics, caution and consideration are maintained, some reasons to support this statement:
- Benefits for the child population, as they lead to the development of safer and more effective therapies to treat childhood diseases, improving medical knowledge and the health of children globally.
- Following strict ethical guidelines that are guaranteed in the consent and Informed consent helps protect the rights of participants.
- In Ecuador, there are laws and regulations that protect children in clinical studies.
