Introduction
Poland has emerged as a prominent player in the global clinical trials arena, offering a unique landscape that combines efficiency, regulatory alignment, and a robust research infrastructure. As a hub for cutting-edge medical research, the country has garnered significant attention from pharmaceutical and medical device companies seeking to conduct innovative clinical studies. In this comprehensive guide, we will delve into the intricate details of conducting clinical trials in Poland, exploring the regulatory framework, submission processes, insurance requirements, and other key considerations that make this country an attractive destination for clinical research.
The Clinical Trial Landscape in Poland
Poland’s clinical trial industry has experienced a remarkable surge in recent years, with a growing number of studies being conducted within its borders. One of the key factors contributing to this trend is the higher productivity of research sites, allowing clinical trials to progress efficiently without unnecessary delays. This is largely attributed to the country’s regulatory environment, which closely aligns with European Union (EU) regulations and directives, providing a streamlined process for trials that adhere to international standards.
In 2020, Poland witnessed the submission of 597 Investigational Medicinal Product (IMP) studies to the Polish Competent Authority, and this number increased to 1,200 IMP studies conducted in the country during 2021. This impressive growth underscores Poland’s appeal as a premier destination for clinical research.
Therapeutic Areas of Focus in Poland
The clinical trial landscape in Poland is characterized by a particular focus on specific therapeutic areas that align with the country’s medical needs, research priorities, and national pharmaceutical interests. The top three indications or therapeutic areas of focus in Poland are:
- Oncology: Cancer research is a critical area of focus, reflecting the global importance of this field and Poland’s commitment to addressing the burden of oncological diseases.
- Cardiology: The prevention, diagnosis, and treatment of cardiovascular conditions, such as heart disease and stroke, are prominent areas of clinical research in Poland.
- Dermatology: Skin conditions, including psoriasis and atopic dermatitis, are another key focus area for clinical trials conducted in the country.
These therapeutic areas of focus not only highlight Poland’s medical research priorities but also demonstrate the country’s ability to contribute to the advancement of healthcare solutions on a global scale.
Obtaining Regulatory Approval
The process of obtaining regulatory approval for clinical trials in Poland involves several key parties and authorities, each with their respective roles and responsibilities. The most prominent entities involved in this process are:
- The Supreme Bioethics Committee (Ethics Committee): This committee provides a positive assessment on IMP studies submitted through the Clinical Trials Information System (CTIS) for trials to be processed by the president of the Regulatory Authority.
- The Bioethics Committees for Medical Device (MD) Studies: These committees are established at Medical Universities or Chambers of Physicians and are responsible for evaluating MD trials.
- The President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL): This individual is the head of the Regulatory Authority and is responsible for approving both IMP and MD studies.
- The Medical Research Agency (ABM): This state agency is responsible for the development of scientific research in the field of medical and health sciences, and it runs one of the first public grant programs to fund non-commercial clinical trials in Poland.
- The Chief Pharmaceutical Inspectorate (GIF): This government organization is responsible for the manufacturing and distribution of pharmaceuticals in Poland, ensuring patient safety.
- The Commissioner for Patient’s Rights: This official government agency serves as the Ombudsman’s agent, designated to protect patient rights.
Submission and Timelines
The submission process for clinical trials in Poland varies depending on the type of study being conducted. For Investigational Medicinal Product (IMP) studies, the application is submitted through the Clinical Trials Information System (CTIS), with Part I and Part II of the documentation being assessed in parallel by the Competent Authority and the Supreme Bioethics Committee.
On the other hand, for Medical Device (MD) and In Vitro Diagnostic (IVD) studies, the initial submission is made to the Bioethics Committee, and a positive opinion from them is required before the application can be submitted to the Competent Authority.
It’s important to note that the submission timelines for these different trial types are also distinct. IMP studies follow the timelines outlined in the Clinical Trials Regulation (CTR), while MD and IVD studies adhere to the timelines specified in the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), respectively.
To ensure a smooth and efficient submission process, sponsors may choose to delegate certain responsibilities to other parties, such as individuals, companies, institutions, or organizations, through written contracts. However, the final responsibility for the submission of a trial to the Competent Authority in Poland lies with the sponsor.
Insurance Requirements
In Poland, sponsors and investigators are required to have compulsory civil liability insurance. This insurance covers third-party liability for claims arising from the activities or negligence of the sponsor or investigator during the clinical trial period.
For low-intervention clinical trials, such insurance is not mandatory. Under the policy, all patients who have signed an Informed Consent Form (ICF) are covered. Any claims by patients should be reported directly to the insurer, ensuring protection for all involved parties.
It’s important to note that certain claims are excluded from the insurance coverage, such as those resulting from addiction, asbestos-related damage, or acts of warfare, riots, and terrorism. Insurance policies must be tailored to each specific trial and cover the appropriate number of Polish participants, meeting the criteria outlined in the relevant regulations.
Outsourcing Considerations
When hiring a Contract Research Organization (CRO) for a clinical trial in Poland, there are no additional national regulations that a sponsor needs to consider. However, it is crucial to ensure compliance with existing regulations, particularly regarding the Clinical Trial Agreement (CTA).
The CTA plays a vital role in defining the rights and responsibilities of the sponsor, investigator, and trial site. These agreements typically involve three parties, but agreements with CROs or co-investigators are also common. It’s important to note that while English is often used in negotiations, sites in Poland typically require bilingual contracts to ensure clarity and understanding.
When selecting clinical trial sites in Poland, sponsors consider the following key criteria:
- Appropriate patient pool to ensure the study can be conducted effectively and recruitment goals can be met.
- Qualified personnel with enough capacity to conduct the trial, with available backup to ensure continuity.
- Necessary equipment and facilities to enable the study to be conducted safely and efficiently.
- Previous experience in clinical trials and any ongoing competitive trials.
By carefully evaluating these factors, sponsors can identify sites that are well-equipped and capable of contributing to the success of the clinical trial.
Navigating Cross-Country Trials
The implementation of the Clinical Trial Regulation (CTR) has streamlined the submission process for Investigational Medicinal Product (IMP) trials in Poland, aligning it with the requirements of other European countries. This ensures efficiency and consistency across borders, making it easier for sponsors to conduct multi-country studies.
However, for Medical Device (MD) trials, there are some unique considerations. The start-up process may take longer than in some other European countries, as the application must be submitted first to the Ethics Committee (EC), and only after receiving their positive opinion can it be forwarded to the Competent Authority (CA).
Additionally, for MD trials, the Competent Authority requires an excerpt from the commercial registration for the Sponsor or EU Representative. This document must be translated into Polish by a sworn translator, adding an extra step to the submission process.
These nuances highlight the importance of understanding the specific requirements for different trial types in Poland and ensuring that the Regulatory Team is well-versed in navigating the country’s unique regulatory landscape.
Assembling the Study Team
All study team members in Poland are required to have a Good Clinical Practice (GCP) certificate, ensuring that everyone involved understands and adheres to ethical and quality standards in clinical research. There are no additional country-specific requirements beyond GCP certification.
However, for Principal Investigators in Poland, GCP certification and experience in conducting clinical trials are essential. When applying for a trial, the resume of a Principal Investigator, including their relevant experience, is evaluated by the Ethical Committee. This ensures that the Principal Investigator is well-equipped to oversee the trial effectively and uphold ethical standards.
According to the Clinical Trials Act in Poland, the principal researcher may be the holder of a license to practice in the country, such as a doctor, dentist, nurse holding a diploma in nursing, or a midwife holding a diploma in midwifery. If a nurse or midwife is the principal researcher, one of the other researchers on the team must be a doctor or dentist, as the Act stipulates that a research team cannot consist solely of nurses or midwives.
Labeling and Distribution Regulations
For Investigational Medicinal Products (IMPs) to be imported, handled, and distributed during a trial in Poland, the application must include specific details, such as the types and forms of the IMP, the manufacturing or import operations, the manufacturing process details (if applicable), the manufacturing site or import destination within the Union, and comprehensive information about the qualified person.
The labeling of IMPs for clinical trials in Poland must be in the Polish language and adhere to the guidelines outlined in Annex VI of the Clinical Trials Regulation (CTR). This includes information such as the name, address, and telephone number of the main contact, the name of the substance and its strength or potency, the pharmaceutical form, route of administration, quantity of dosage units, the clinical trial reference code, and the subject identification number.
For Medical Devices (MDs), the labeling and user interface requirements differ based on whether the device is intended for laypeople or non-lay users. For devices targeting laypeople, the labels, instructions, and user interface should be in Polish or standardized symbols/codes, and the EU declaration of conformity or relevant statements per the Medical Device Regulation (MDR) must be adhered to, either in Polish or translated. For devices targeting non-lay users, the EU declaration of conformity or relevant statements per the MDR must be adhered to, and the labels and instructions can be in Polish or English, with patient-related information in either Polish or standardized symbols/codes.
Informed Consent Procedure
In Poland, the Informed Consent Procedure for clinical trials requires that consent can only be obtained in person. This means that eConsent is not allowed. Patients must have ample time to decide on their participation and have the opportunity to ask the investigator questions about the trial.
The patient signs the Informed Consent Form (ICF) first, and the investigator conducting the informed consent process countersigns. For pediatric studies, the legal requirement is that minors can only participate with written consent from their legal representative, such as both parents or a court-appointed guardian. In the case of disagreement between guardians, the matter may be resolved by the guardianship court.
The ICF in Poland must include several essential components, such as consent for the processing of personal data, information about the insurance policy covering participants and sponsors, and details about the Compensation Fund, which provides recourse in case of trial-related injury. Additionally, the ICF must provide comprehensive information about the trial, including its nature, objectives, benefits, risks, and any possible alternative treatments.
Adverse Event and Serious Adverse Event Reporting
The responsibilities of the sponsor and investigator regarding safety monitoring in Poland follow the guidelines outlined in Article 48 of the Clinical Trials Regulation (CTR) and Article 72-2 of the Medical Device Regulation (MDR).
For studies submitted through the CTIS portal under the CTR, annual patient safety reports and reports of unexpected serious adverse reactions to medicinal products should be submitted accordingly. This includes sending annual subject safety reports to the ASR EudraVigilance Module in the CTIS portal and reporting unexpected serious adverse reactions directly to the EudraVigilance Clinical Trial Module.
For active substances not yet included in the CTIS, annual reports on the safety of participants should be submitted to the President of the Office electronically by sending a message containing EudraLink to the designated email address.
Data Protection and Patient Privacy
Compliance with the European General Data Protection Regulation (GDPR) is of utmost importance in ensuring the protection of patient privacy during clinical trials in Poland. This is achieved through the requirement of pseudonymization, where patients’ personal data is replaced with pseudonyms to prevent identification.
Patients’ personal data never leaves the trial site, and only documents with masked patient information, where the patient’s name is replaced by a patient ID, can be transferred to the sponsor. To facilitate this process, each patient must sign a GDPR consent form as part of the Informed Consent Form, agreeing to the transfer of their pseudonymized data to the sponsor and allowing access to Clinical Research Associates (CRAs), auditors, or inspectors for monitoring purposes.
This comprehensive approach to data protection and patient privacy ensures compliance with GDPR while enabling necessary data transfer and access for effective trial oversight.
Audits and Inspections
Audits and inspections play a crucial role in ensuring the integrity and compliance of clinical trials conducted in Poland. Audits are independent reviews of trial activities and documents, conducted by the sponsor or an independent auditor, to ensure that trial activities are carried out properly and that data is recorded, analyzed, and reported accurately.
On the other hand, inspections are conducted by the regulatory authority, the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL), which is the Polish Competent Authority. These inspections can take place at the trial site, the sponsor’s facilities, the CRO’s facilities, or any other relevant locations.
The inspection process in Poland involves both routine inspections, with a 30-day advance notice, and unannounced inspections, which are carried out when there is a suspicion that the life or health of clinical trial participants might be at risk. During the inspection, inspectors review documents, interview individuals involved in the trial process, and examine storage facilities and samples.
The inspection report, which can be provided in paper or email format, is delivered to the sponsor and investigator within a specified timeframe, typically 44 days for Investigational Medicinal Products (IMPs) and 60 days for Medical Devices (MDs). The report details any findings, referencing the legislative acts breached, and grades the findings as Critical, Major, Minor, or Comment, providing guidance for addressing any issues identified.
Publication and Submission of Clinical Trial Results
The disclosure of clinical trial results in Poland is governed by specific regulations and requirements. For Investigational Medicinal Product (IMP) trials, the results are submitted to the Clinical Trial Information System (CTIS), and a detailed Clinical Study Report (CSR) is required for trials used to obtain market authorization for the drug.
For Medical Device (MD) trials, the Clinical Investigation Report (CIR) is submitted to both the Competent Authority (CA) and the Ethics Committee (EC). This report consolidates the findings of the clinical investigation conducted on the medical device.
Importantly, for both IMP and MD trials, a summary of the results in a format that is understandable to a layperson must also be published alongside the technical reports. This ensures that clinical trial results are accessible to the general public, fostering transparency and public trust in the research process.
Post-Trial Obligations and Document Archiving
After the completion of a clinical trial in Poland, sponsors have several post-trial obligations to fulfill. These include submitting the Clinical Study Report (CSR) or the Clinical Investigation Report (CIR), archiving documentation, and providing access to documents during inspections.
The sponsor must inform the trial site about the duration of document archiving, which is 25 years, in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH GCP) and EU Regulations such as the Clinical Trials Regulation (CTR) and the Medical Device Regulation (MDR). During the Close Out Visit (COV), the sponsor emphasizes that document destruction requires their approval, and once the archiving period has elapsed, the sponsor notifies the site that documentation can be safely destroyed.
This meticulous approach to post-trial obligations and document management ensures compliance, accountability, and the long-term preservation of essential data, which is crucial for the integrity and transparency of clinical research conducted in Poland.
Conclusion
Poland’s clinical trial landscape has emerged as a compelling destination for pharmaceutical and medical device companies seeking to conduct innovative research. With its efficient research sites, aligned regulatory environment, and focus on key therapeutic areas, the country offers a unique and attractive proposition for global clinical trials.
By understanding the intricacies of the regulatory approval process, submission timelines, insurance requirements, and other critical considerations, sponsors can navigate the Polish clinical trial landscape with confidence and ensure the successful execution of their studies. The country’s commitment to patient safety, data protection, and transparency further reinforces its position as a leading hub for cutting-edge medical research.
As the clinical trial industry in Poland continues to grow and evolve, this comprehensive guide provides valuable insights and guidance for sponsors, investigators, and industry stakeholders looking to leverage the country’s robust research capabilities and contribute to the advancement of healthcare solutions on a global scale.
