CTU and Early Phase

We are about to create a dedicated, separate unit – the Clinical Trials Unit together with infrastructure necessary to carry out the early phase clinical trials (Early Phase Clinical Research Centre). Creating comprehensive solutions in the field of planning, management and implementation of clinical trials together with the Centre’s operation will allow centralization and sharing of key support resources.

Strategic objectives:

  1. Increasing the quality of clinical trials carried out by the University;
  2. Increasing the role of the University in the process of clinical trial implementation;
  3. Increase in the level of internationalization;
  4. Increase the impact and visibility of the University in the area of clinical research;
  5. Diversification of revenues from research activities;
  6. Consolidation and extension of the University clinical base within which clinical trials are carried out;
  7. Effective use of clinical resources;
  8. Ensuring the quality of collection, processing and analysis of research data;
  9. Ensuring safety for every participant in clinical trials.

Research scope of the early phase centre

The Early Phase Clinical Research Centre will be profiled for the implementation of early phase projects covering the majority of medical areas with particular reference to oncology. Phase I-II clinical trials, clinical trials assessing the efficacy and safety of biosimilar and bioequivalent drugs, or closely-monitoring pharmacokinetic and pharmacodynamic studies will be carried out as part of the research program. The centre will also be a suitable place for conducting projects taking into account the evaluation of the safety and efficacy of medical devices.

The foreseen research plan primarily relates the analysis of the effectiveness and safety of innovative medicinal products developed mainly in cooperation with leading pharmaceutical companies, which have the greatest scientific and research potentail. The conducted research will express the current needs of the pharmaceutical market and will be the implementation of commercial entities’ plans to market medicines and enable start-ups and small innovative companies to conduct early research that will enable them to commercialize or license their own products. For this reason, the research plan is to create a space to conduct this type of research in optimal conditions, unrestricted by determinants of typical hospital wards.

The research plan will be reactive in relation to national and global trends and assume the implementation of projects under the three main axes:

Axis 1 – clinical trials of medicinal products including projects aimed at molecular targets and related to the activation of immunological mechanisms used in the oncological area

Axis 2 – clinical trials of medicinal products in neurological indications, cardiovascular diseases, respiratory diseases, diabetology and rare diseases

Axis 3 – clinical trials of medical devices (including telemedicine solutions) with particular emphasis on cardiology, including electrocardiology, and diabetology and other chronic diseases. Despite the dynamic development of the medical devices industry, both in Poland and throughout Europe as well as globally, centres specializing in clinical trials dedicated to confirming the functionality / safety of medical devices are few in number.

Share: