Decentralisation of clinical research in Poland: current status, challenges and recommendations

Clinical trials are and will remain crucial to drug development and the improvement of patient health. In Europe, approximately 80 per cent of clinical trials experience difficulties in obtaining or retaining an adequate number of participants, leading to increased costs and delays in bringing a medicinal product to market or even abandonment of the project altogether. Despite the increasing number of clinical trials and maintaining a strong position in the global clinical trials market, Poland is no exception.

The so-called decentralised clinical trials (DCTs) were intended to address these problems. This is a model of conducting trials in which some or all trial procedures are carried out outside the traditional research centre (often at the participant’s home), using telemedicine, remote monitoring, wearables, digital technologies and other tools. Decentralisation also enables research centres to involve local healthcare facilities in providing clinical trial services. This approach makes it possible for people with limited mobility, those living in rural areas, socio-economically disadvantaged people and patients with rare or severe diseases to participate in trials. It is also a solution for those who would otherwise have opted out due to onerous travel to a distant research centre. For study sponsors, this means greater diversity in the study population, while study centres are less burdened by the number of visits and the extent of staff involvement.

In Poland, the COVID-19 pandemic accelerated the adaptation of some elements of DCTs, such as remote medical visits allowing participants to consult a doctor without being physically present at the study centre (teleconsultation), direct-to-patient (DTP) drug delivery and remote data collection and monitoring, for example within the framework of an electronic Case Report Form (eCRF). Despite the obvious benefits of decentralising research, after a period of rapid development during the Covid-19 pandemic, further implementation of this model has been slow.

An obstacle to fully exploiting the opportunities offered by DCTs is the slow emergence of decentralisation regulations in both EU and national legislation. The key piece of legislation regulating clinical trials in the European Union is Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014. (“the Regulation”). In Poland, clinical trials are regulated by the Act of 9 March 2023 on clinical trials of medicinal products for human use (the “Act”). The Act brings Polish law in line with EU regulations; however, it does not contain specific provisions on DCTs.

In December 2022, the European Commission and the European Medicines Agency (EMA) published a document entitled Recommendations on Decentralised Elements in Clinical Trials (the “Recommendations”), intended to provide Member States with more detailed guidance on implementing procedures for conducting trials outside traditional clinical trial sites. In addition, Annex 2 of the new ICH E6(R3) International Standards for Good Clinical Practice (“ICH E6(R3)”), seeks to expand the guidance on decentralised elements, such as platforms for remote participant monitoring, data collection and integration with the latest technologies. Although the ICH E6(R3) Guidelines entered into force on 23 July this year, Annex 2 is currently still in public consultation. Stakeholder views were published on 20 May on the European Medicines Agency website (https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ich-e6r3-guideline-good-clinical-practice-annex-2-step-2b_en.pdf).

Consequently, the most comprehensive discussion of the introduction of decentralisation elements in clinical trials remains the non-binding Recommendations. While these provide useful guidance on remote informed consent, roles and responsibilities of trial actors, delivery of medicines directly to participants and data collection and management, it is important to remember their non-binding and general nature. Many provisions will not be applicable in Poland without legislative change and harmonisation; practical implementation will require sponsors to seek non-binding regulatory interpretations.

Process for obtaining informed consent remotely

Informed consent is the basis for conducting clinical trials. According to the Recommendations, because of the greater risk of error, discussions between the investigator and the potential trial participants should take place in person, except where the trial protocol specifically details and describes the remote consent procedure. Remote interviews should occur in real time via an audiovisual connection, enabling the trial participant to ask questions and obtain clarification. If the patient’s informed consent is signed using digital tools, the process must be verifiable and comply with relevant EU and national legislation.

In the absence of specific national provisions, the Medical Research Agency, in non-binding recommendations, has confirmed that a patient’s informed consent can be signed using electronic forms of signature – whether qualified or other digital forms. However, there are still no clear, binding national legal guidelines on how the e-consent process should operate (e.g. in terms of tools, identity verification methods or archiving). While the use of a qualified electronic signature (legally equivalent to a handwritten signature) is widely accepted, submission in documentary form (via emails, SMS, PDF files, etc.) remains controversial.

Entities involved in decentralised clinical trials

Given the shortage of specialist physicians in Poland, involving other medical professionals, such as nursing teams, in the execution of trial protocol procedures is a significant opportunity. The Act already allows nurses and midwives with appropriate training to act as principal investigators in a clinical trial of a medicinal product. Where other parties outside the trial site (e.g. nurses or other health professionals providing clinical trial services) are involved in DCTs, their roles and responsibilities must be clearly defined before the trial begins.

The Recommendations emphasise formal aspects: specifying in detail who performs the tasks, when and where and how supervision and delegation are ensured. If tasks are delegated to external service providers, their role and responsibilities must be described in the clinical trial protocol and appendices. The Investigator remains fully responsible for medical decisions such as trial participant eligibility and medical procedures. All delegated tasks should be covered by written contracts and the investigator should have the right to refuse or amend the terms of collaboration. Protocols must also include plans for effective communication and emergency situations

The Act does not prohibit delegation of protocol procedures to external entities, so adherence to the Recommendations’ standards should be sufficient for approval of such trials in Poland.

Delivery and administration of the investigational medicinal product (IMP)

According to the Recommendations, the IMP should only be delivered to the trial participant (or authorised representative) or a healthcare professional present in the home. The protocol should provide for verification procedures to ensure correct delivery and clear instructions on storage and administration – particularly for self-administered medicines.

The Regulation does not explicitly mention home delivery. National legislation was expected to provide the framework, but the Polish Act neither prohibits nor regulates it. In the questionnaire annexed to the Recommendations, the Polish regulator opposed most direct-to-home delivery options, except delivery between the trial site and the participant and between the hospital pharmacy at the site and the participant. Delivery directly from the manufacturer was excluded.

Accordingly, it is crucial to include any permitted delivery arrangements in the trial protocol, secure approval from the President of the URPL and the National Commission and comply with the Regulation and the Act. The legislator should consider amending the Act to allow for safe, regulated direct-to-home delivery of IMPs, while maintaining high patient safety standards.

Data collection in DCTs

In DCTs, much of the data collection shifts from the trial site to participants, caregivers or service providers, such as community nurses. Data may be recorded directly using systems such as an electronic case report form (eCRF), an electronic patient-supported outcome (ePRO) or wearable devices. According to ICH Guideline E6(R3), data must be valid, reliable, verifiable and personal data processing must comply with data protection law.

The involvement of multiple systems and parties requires effective sponsor oversight and security measures. Sponsors should prepare a data flow chart, ensure that tools are validated for their intended use and define the scope of data collected. Data should be encrypted during transfer, with strict access controls. Protocols should include safety alert mechanisms for serious adverse events (SAEs) and specify responsibilities for action.

Participants should be informed in advance about how e-tool-reported data will be used and that not all data will be monitored in real time. They should have direct contact with the investigator in emergencies.

Telemedicine and remote monitoring

Although the Publicly Funded Health Services Act and the Medical and Dental Professions Act allow for teleconsultation in clinical practice, it is not clearly defined whether and how it can be used in clinical trials. There are no provisions for recording, documenting or securing data from remote consultations in this context. While the Regulation permits remote monitoring and inspections, the on-site model still dominates in Poland and the absence of national guidelines creates uncertainty for sponsors and sites.

Conclusion

Poland has historically been a significant global player in clinical research. To maintain this position, clinical research should be considered a strategic industry for the economy. Rapid adoption of digital technologies in healthcare will be decisive for the further development and innovation of the Polish clinical research market.

While the introduction of the eCRF system for non-commercial research by the Agency for Medical Research (ABM) is a step toward modernising the process, there is currently no clear, comprehensive national framework governing the use of telemedicine, remote visits, home delivery of medicines or remote data collection in clinical trials. Creating a coherent legal system, coupled with patient and medical staff education and investment in digital infrastructure, will be key.