Our Voice in the Nationwide Journal “Badania Kliniczne”

Dr. Grzegorz Kuczyński, the researcher from the Penta Hospitals centre in Gdańsk, publishes in the journal “Badania Kliniczne”

The PI-House Clinical Research Centre in Gdańsk, part of the Penta Hospitals Poland network, was the first commercial centre in Poland to initiate clinical trials involving psychedelic substances. In doing so, it set a new direction for the development of modern research in psychiatry and neurology.

Responding to the growing demand for reliable knowledge on innovative therapies in the treatment of mental disorders, Dr. Grzegorz Kuczyński – the researcher and the member of the CNS (Central Nervous System) team – published an article entitled:
“Differences and Specific Requirements of Clinical Trials Involving Psychedelics Compared to Standard Clinical Trials” in the nationwide industry journal “Badania Kliniczne.”

The publication constitutes a significant opinion of a practitioner whose experience in conducting psychedelic research is increasingly visible and recognized within the clinical research community.

The article presents the key methodological, ethical, and regulatory challenges associated with conducting psychedelic clinical trials (PSY-CT). The author notes that, as of May 2024, 278 clinical studies involving classic psychedelics, MDMA, and ketamine had been registered in international databases, confirming the rapid growth of this field.

The publication emphasizes that research on psychedelics differs significantly from standard clinical trials and requires a specialized organizational and clinical approach. A well-trained, interdisciplinary team is essential – one that includes not only physicians and nurses, but also qualified psychologists who accompany patients during sessions involving the administration of the test product. Another important element is the incorporation of the set & setting concept, meaning the deliberate shaping of environmental conditions that directly influence both the safety and effectiveness of the therapy.

The author highlights that conducting this type of project requires a hybrid research model that combines pharmacological rigor with intensive psychological support, as well as particular attention to safety and long-term follow-up of participants. This is a field that demands the highest organizational, ethical, and clinical standards – standards that we have been building and consistently developing in our Centres since the beginning of our work in this segment of research.

The publication by Dr. Grzegorz Kuczyński represents an important contribution to the ongoing discussion on the quality, ethics, and safety of psychedelic research in Poland. It also confirms that Penta Hospitals Poland not only conducts research projects but actively contributes to shaping the standards by which they are carried out.

As a pioneering centre in the field of commercial psychedelic research, we consistently combine the highest GCP standards with an interdisciplinary clinical and psychological approach.

Importantly, the development of psychedelic research within the Penta Hospitals Poland structure is not limited to Gdańsk. Further expansion of commercial clinical trials in this field is also planned and underway in Olkusz, marking another step in building nationwide capacity in innovative psychiatric therapies.

We believe that responsibly conducted clinical trials involving new substances can significantly transform the treatment of mental disorders in the future – especially in cases of treatment-resistant depression and other difficult-to-treat conditions.

Clinical Research Team
Penta Hospitals Poland