Clinical trials in Poland – status as of 2025

Clinical trials in Poland have developed significantly over the past 30 years. In 2024, Poland ranked 9th in the global commercial clinical trials market, translating into a 2.68% market share. These high results have allowed Poland to create approximately 9,400 jobs and provide 26,800 patients with access to innovative and cutting-edge experimental therapies. The medical research industry in Poland is growing rapidly, making it an attractive investment destination. According to the report, the world’s largest industry sponsors are the dominant sponsors in Poland. They account for 43% of all active industry-run research centers worldwide and 47% of active centers in Poland. This demonstrates Poland’s strong integration with global clinical trial networks. It is important to note that Poland’s growth in the clinical trials sector occurred after the challenging pandemic years. Due to the epidemiological threat and mobility restrictions imposed by the pandemic, the development of commercial clinical trials has been hampered. These were replaced by research on the SARS-COV-2 disease, as there was an urgent need to study the new disease and develop a treatment due to the global COVID-19 pandemic. Despite the pandemic and the increased attention focused on researching the new virus, Poland has not completely abandoned the development of clinical trials, as evidenced by the Polish Clinical Trials Network.

The Polish Clinical Research Network was established in March 2021 to standardize systemic quality and process solutions for entities conducting and implementing clinical trials in Poland. Its goal is also to develop Clinical Research Support Centers, which were established to standardize the implementation of commercial and non-commercial clinical trials in Poland. As a result, the Clinical Research Support Centers (CWBKs) are expected to increase the number of clinical trials in Poland and thus expand the range of modern therapies available to patients. CWBKs are staffed by professionals who assist at all stages of conducting and managing clinical trials, providing tools that can help facilitate the implementation of clinical trials. CWKB focuses primarily on ensuring that trials are conducted to the highest possible quality and in the safest possible conditions for patients. The number of CWKBs is steadily increasing, meaning more and more facilities are investing in the development of clinical trials. The Polish Clinical Research Network standardizes clinical trial standards to encourage sponsors to conduct them at public centers such as CWBKs.

Clinical trials law

Polish clinical trials are regulated by the Act on Clinical Trials of Medicinal Products for Human Use of March 9, 2023. This act primarily governs the procedure for issuing permits for clinical trials of products intended for human use, specifies the procedure for entering and deleting individuals from the list of bioethics committees (ethics committees are independent teams of experts, usually multidisciplinary, that assess whether planned trials are legal, ethical, and safe), establishes the Clinical Trials Compensation Fund, which operates under the Patient Rights Ombudsman, and introduces protections for clinical trial participants.

The Supreme Medical Council is calling for an amendment to the Act on Clinical Trials for Medicinal Products for Human Use. This is due to the growing number of clinical trials conducted in Poland. The Supreme Medical Council (NRL) calls for an increased role for independent bioethics committees to ensure high-quality substantive and ethical evaluation of clinical trials. The Medical Council also notes that medical chambers currently bear the full burden of funding and proposes that the committees be financed from fees paid for clinical trial authorization applications. The Supreme Medical Council is also calling for physicians to constitute a larger percentage of the review panel. Currently, this number is limited to one representative of a scientific discipline: medicine, pharmacy, or health sciences. The NRL wants to increase the scope of substantive discussion and thus raise the team’s standards by changing the composition of the review panel to include at least three physicians.

Clinical Trials Development Plan to 2030

The President of the Medical Research Agency has published the Clinical Trials Development Plan for 2020–2030. This document contains strategic goals and tools that must be used to enable the development of clinical trials in Poland.

In the area of clinical research, the goal is to develop and improve the quality of clinical trials and research experiments. According to the report, clinical trials are a key element in the development of modern medicine due to access to modern and innovative therapies (and thus, increasing the quality and accessibility of the healthcare system for patients). This goal is to be achieved through the development of commercial and non-commercial clinical trials – that is, through the organization of competitions for the financing of commercial and non-commercial clinical trials that take into account patient needs, consider health priorities, and directly compare medical technologies. Another tool that will help achieve the aforementioned goal by 2030 is the development of medicine by supporting research experiment projects in competitions that involve, among other things, the development of new diagnostic protocols or interventional treatment methods. Among the projects underway are: comparing various surgical techniques, developing principles for an optimal care model, assessing the effectiveness of non-drug interventions administered to patients, and developing a diagnostic algorithm based on the collected data. The application of these methods is expected to result in, among other things, The report includes the development of new treatment methods using commercially available medicinal products and medical devices, the optimization of modern treatment, the development of the pharmaceutical and biotechnology industries, and increased patient access to specialized healthcare. The report mentions support from Polish legislators in developing the clinical research sector in Poland. These efforts are expected to align Polish legislation with European clinical research standards. The document also envisages the training of clinical research staff to enhance their competencies. To achieve this, training courses and conferences are planned, as well as cooperation in opening new postgraduate programs. The report also focuses on the development of commercial and non-commercial clinical research infrastructure in Poland.

The report shows that the development of clinical trials in Poland is planned comprehensively – from drafting legal amendments, through developing new treatment methods, to optimizing and modernizing current medical methods for treating patients. Poland is primarily an attractive location for pharmaceutical companies, who see it as a potential sponsorship opportunity. This sector faces various challenges, but this has not hindered its rapid and innovative development.

Artykuł Plan for the development of clinical trials in Poland until 2030 pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Investigator status

The legal status of an investigator is determined based on Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and the Polish Act of 9 March 2023 on clinical trials on medicinal products for human use .

If a clinical trial is conducted by a team, the principal investigator is the primary investigator. If there is only one person responsible for conducting the clinical trial, the investigator is the primary investigator. This distinction is important because it determines who can, respectively, fulfill the roles of investigator and principal investigator.

The researcher may therefore be a doctor or, pursuant to Article 49 of Regulation 536/2014, a person exercising a profession with the necessary knowledge and experience in working with patients, who is permitted to be a researcher in a given Member State.

If the entire team is responsible for conducting a clinical trial, the principal investigator must be a physician, dentist, nurse, or midwife, as stipulated in Article 37 of the Clinical Trials of Medicinal Products for Human Use Act. This regulation seems appropriate because it allows these professions to prescribe medications independently without medical assistance.

A proposal to include a pharmacist was also made, but this was rejected. However, a pharmacist, like a laboratory diagnostician or other healthcare professionals, may also be part of the research team. However, as stated in paragraph 2, if the principal investigator is a nurse or midwife, the team must include a physician or dentist. The investigators’ qualifications should be presented in the application for permission to conduct a clinical trial.

Under Article 4.1 of the Principles of Good Clinical Practice, the investigator should also be able to formally demonstrate their competence by submitting documents required by the sponsor, the Independent Bioethics Committee, or the relevant authorities. However, the Principles of Good Clinical Practice do not provide any further guidance on whether the investigator should be the most qualified person on the team.

The selection of the principal investigator should be made with due care, as his or her possible replacement is linked, under Article 15 of Regulation No. 536/2014, to the procedure for issuing an authorisation for a substantial modification of a clinical trial.

Under Article 71 of Regulation No. 536/2014, an investigator may also act as a sponsor. This is the next person with status in the clinical trial procedure. Their primary responsibilities include initiating the clinical trial, managing it, and ensuring its financing, as defined in Article 2, paragraph 2, point 14 of Regulation No. 536/2014.

Under Articles 42 and 43 of the Clinical Trials of Medicinal Products for Human Use Act, the Patient is also obligated to make a contribution to the Clinical Trials Compensation Fund before the trial begins. This fund was established to provide financial support to individuals injured as a result of participating in clinical trials that began after April 14, 2023, or to the families of individuals who died as a result of participating in trials.

However, if these two functions are not combined in one person, then pursuant to Article 36 paragraph 1 item 2 of the Act on Clinical Trials of Medicinal Products for Human Use, the sponsor must seek the consent of the investigator or principal investigator (issued in writing) if he or she wishes to obtain access to source documents.

Rights and obligations of the investigator

The investigator or principal investigator has specific rights and responsibilities. Their responsibilities include ensuring that the clinical trial at the clinical trial site complies with the requirements of Regulation No. 536/2014 and that the clinical trial is conducted in accordance with the protocol and the principles of good clinical practice, as set out in Articles 73 and 47.

Four basic responsibilities also include:

– providing comprehensive information about the study conducted and obtaining informed consent from participants to participate in accordance with Article 29 of Regulation No. 536/2014;

– tracking all cases where individuals refused to participate in the study or withdrew from it pursuant to Article 30(4) of Regulation No. 536/2014;

– providing information to the appropriate branch of the Provincial National Health Fund regarding the inclusion of a participant in a clinical trial or its exclusion (within 30 days of the date of occurrence of a given event) pursuant to Article 60 of the Act on Clinical Trials of Medicinal Products for Human Use;

– reporting adverse events and serious adverse events to the sponsor pursuant to Article 41 of Regulation No. 536/2014, taking into account that serious adverse events must be reported within 24 hours of becoming aware of them.

In addition, the investigator also has certain information obligations under Article 56 – he or she shall record, process and store all information relating to the clinical trial in a manner that allows for its accurate reporting, interpretation and verification, while protecting the confidentiality of participants’ records and their personal data in accordance with applicable data protection law.

In addition to the above, the investigator should also keep the clinical trial master records pursuant to Article 57 of Regulation No 536/2014, which, pursuant to Article 58, should be archived for 25 years.

In some cases, the investigator is also responsible for overseeing the administration of medication to the participant and the amount of product dispensed (this procedure must also be properly documented), particularly in smaller research centers. This task may also be performed by a co-investigator or, in larger facilities, a pharmacist.

On the one hand, the investigator, as a responsible person, supervises the entire team and other subcontractors, including delegating tasks within his/her colleagues, and on the other hand, he/she also has many general tasks that result from his/her position:

a/ supervising the level of knowledge and skills of the research staff to ensure the proper conduct of the study;

b/ ensuring the safety of clinical trial participants;

c/ responsibility for each violation of the study protocol;

d/ supervising the course of the study, including the preparation of the final report and being responsible for financial settlements;

e/ ensuring that the protocol is approved by the regulatory authorities and the Bioethics Committee;

f/ ensuring that each person making up the team knows how to perform their duties, has completed the required training, has the required education and is familiar with the protocol and procedures of the study.

Artykuł THE ROLE OF THE INVESTIGATOR IN CLINICAL TRIALS pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.