The pharmaceutical industry strengthens its commitment to pediatric clinical research and already promotes nine out of ten trials in this field

Farmaindustria participates in Santiago de Compostela in the II National Meeting of the Spanish Network of Pediatric Clinical Trials

Source: www.farmaindustria.es

The research and development of new drugs specially adapted for pediatric patients has been carried out mostly by the pharmaceutical industry in recent years. Specifically, 88.7% of the clinical trials authorized since 2015 and until September 16 in the field of pediatrics by the Spanish Agency for Medicines and Health Products (Aemps) have been promoted by pharmaceutical companies.

This was explained on Tuesday in Santiago de Compostela the head of the Platform for Innovative Pharmaceutical Industry Drugs, Amelia Martín Uranga, in her speech at the II National Meeting of the Spanish Network of Pediatric Clinical Trials (Reclip), which was developed under the Title Pediatric clinical research in the national and international context: Reclip and Conect4Children.

The representative of Farmaindustria highlighted that these trials seek, in the first place, to guarantee the safety and efficacy of new drugs for infants, children and adolescents, but at the same time also allow early access of pediatric patients to therapies. more innovative

“Fortunately, and thanks in part to the growing interest of pharmaceutical companies, clinical research aimed at developing specific treatments for pediatric patients is growing steadily in Spain, from 13% of the total authorized clinical trials in 2016 to 14% in 2017 and at 14.9% in 2018, ”he added.

Term and therapeutic areas

At the same time, the deadlines for the start-up of the trials have been gradually reduced, a key factor in attracting investments in this area by companies. Thus, according to the latest data from the BEST Project of excellence in clinical research, the implementation of pediatric clinical trials, from the delivery of documentation to the health authorities to the inclusion of the first patient, has been reduced by almost 25% from 2015 until reaching 128 days in 2018.

By therapeutic areas, the greatest research efforts of the companies are in the field of oncology, which includes 20% of the total pediatric clinical trials driven from the industry. Hematological medications (15.4%), anti-infectives (12.3%), treatments against cardiovascular diseases (9.2%) and those that fight respiratory conditions (9.2%) are other drugs in Experimentation phase that focuses the attention of the R&D departments of the laboratories.

Other key areas for the development of pediatric clinical trials are rare diseases, autoimmune diseases, diabetes, asthma, atopic dermatitis, psychiatry or vaccines.

Trials of greater complexity

Clinical trials of drugs aimed at children are more complex, both because of their design and because of the procedures and difficulties of recruiting patients, said Amelia Martín Uranga, who highlighted the strengths of Spain to face these challenges successfully because it has centers to treat the pediatric population with a high scientific, care and human level, as well as reference centers to address certain diseases.

“Although we still have to move forward to have more human resources and stronger structures, increase the involvement of hospital managers and experience levels, the truth is that Spain has an excellent profile, both for its health professionals and researchers and for its centers , to host clinical trials of this type that involve real contributions for pediatric patients, ”adds the Pharmaindustrial representative.

Another key to the future development of this type of research is to continue working within the framework of a model of private public collaboration. Good examples of this scheme are the initiatives promoted by the European Initiative for Innovative Medicines (IMI), such as conect4children, a public-private European network that facilitates the development of new drugs and other therapies for the pediatric population; o Conception, which is a project that aims to generate proven information on medication safety during pregnancy and lactation.

Also noteworthy is the case of the European Platform for Preclinical Concept Test in Pediatrics (ITCC-P4), which develops 400 preclinical models from cells and tissues of patients from ten of the most common childhood cancers, including glioma, neuroblastoma and osteosarcoma, in order to identify subgroups of patients that could respond better to certain treatments.

Finally, Amelia Martín referred to training in R&D as another key to the future that will continue to strengthen the performance of pediatric clinical trials. Cited