How research sites in Poland are classified?

Dive into this article, led by one of our most excellent experts, Łukasz Bęczkowski , and understand how Research Sites in Poland are set up and classified. One of the main reasons why Poland is considered one of the most important Clinical Trial markets in Europe.

They are classified into three general categories depending on the type of structure or installation:

Hospitals:

• University hospitals,

• Public and private hospitals in general,

• Hospitals are governed by private government agencies, such as the Ministry of defence or the Interior Ministry. The most significant number of Sites conducting Clinical Research in Poland belongs to this category.

Hospitals participate in all phases of Clinical Research projects, from early phases to post-marketing authorisation projects. They offer excellent access to Patient populations across multiple Therapeutic Areas and experienced Investigators.

Usually, the downside of this model has been:

• A lack of administrative support resources,

• Longer average Clinical Trial agreement negotiation timelines.

The primary focus is on statutory healthcare activities that continuously compete for resources.

Historically, the pain point of clinical trial administration at hospitals was that in a vast majority of cases, it remained with medical staff;

however, in recent years, the development of support units for Clinical Research has begun at Hospitals.

These units support Hospital staff training, study registration and ethics submissions, contracting process, study documents maintenance, and data entry.

It is worth mentioning that Hospitals and Academic Institutions, in particular, are the main habitats of Non-Commercial research; the percentage of Non-Commercial studies registered in Poland remained at 2% in 2019, significantly below the benchmark of Western European countries. ( Data from the INFARMA Pl. report).

In 2019, the government established the Medical Research Agency (ABM) to support research in medicine and health sciences and non-commercial research. One of the projects funded by the ABM was the creation of specialized Clinical Research Support Centers as a shared service ensuring complex and systemic support of both non-commercial and commercial studies. In the same year, the ABM began developing the Polish Clinical Research Infrastructure Network (POLCRIN) and joined the European Clinical Research Infrastructure Network (ECRIN) with observer status.

Mobile sites (non-dedicated):

This group includes:

• Ambulatory facilities (outpatient clinics) are primarily focused on healthcare, with Clinical Research remaining an add-on activity.

These are ambulatory (multi) speciality clinics, less frequent primary care practices, and individual or group physician practices. And can be characterized by promising access to Patient populations; however, they are usually limited to practising specialities.

As most of these Sites are privately owned, site contracting processes are usually faster than large public Hospitals due to a shorter approval pathway and quicker turnaround of documents.

Typically, Clinical Research administration processes at these Sites are supported by mid-level medical or administrative staff, often only part-time.

Patient capacity and limited resources dedicated to research are often limiting factors of these research Sites. The advantage is the Patient-Doctor relationship which usually exists before the study and continues post-study participation.

Dedicated research sites/Site Management Organizations:

This type of Research Site Organization model is the smallest in number, however, rapidly growing in recent years.

We allocated the standalone or network Sites (ambulatory in most cases) where Clinical Research activities constitute not less than 50% of site activities.

A dedicated Research Site demonstrates continuous engagement in Clinical Trial projects.

The Site may (or may not) provide regular healthcare services. However, in contrast to the Mobile Site's model, the proportion of healthcare in overall activities is less than 50%.

Dedicated Sites which do not provide regular healthcare activities usually require proactive Patient recruitment tactics or established cooperation with non-resident investigators to ensure the achievement of expected enrollment targets.

These Sites usually offer dedicated administrative study support teams in the field of study start-up, project coordination, data entry, patient recruitment, and quality control.

For many years, Poland has had dedicated sites specializing predominantly in human (FIH) and bioequivalence and pharmacokinetic studies. Depending on the Study type, these Sites enroll either Patients or healthy volunteers.

Although these early phase Sites in Poland exist primarily

within a Hospital setting, due to their dedicated facilities and personnel, these early phase Sites are classified as dedicated research sites/SMO.

Check this overview of research site types in Poland, considering their focus, study type (commercial/non-commercial focus), and study phases.

"This tendency reflects the shift of Investigators' preferences towards conducting commercial research outside of the traditional Hospital environment (whenever possible due to the nature of therapeutic indication and protocol design) due to several reasons, including:

• Availability of experienced, dedicated study administrative support Teams.

• Organization of the study-related processes ensuring better PI oversight.

• A faster-contracting process is enabling investigators more time for patient enrollment ".

By Łukasz Bęczkowski.

This interesting article is part of "Report Industry Clinical Trials in Poland. Possibilities to increase number and scope of trials in Poland.2021" – commissioned by INFARMA and POLCRO, in which our expert Łukasz Bęczkowski has collaborated.

———————————————————————————————————

Pratia is a Platform for Innovative Medicine with more than 90 Sites in six European countries.

Each of our countries provides excellent benefits and clear opportunities for developing numerous Clinical Trials.

Contact us to learn how we can help you achieve success in your Clinical Trial.