Healthcare Poland Foundation is launching a Clinical Trials Department (DBK). Its task is to remove the barriers that cause clinical trials to bypass Polish hospitals or to start there with months of delay. The department is headed by Klaudiusz Gajewski, MPharm.
Diagnosis
The most serious constraint on commercial clinical trials in Poland today is neither science nor patient access, but the process of concluding the agreement between a site and a sponsor. Every hospital negotiates on its own, and the same issues return in every contract: data protection, governing law, liability, insurance, ownership of results. Time that should be counted in weeks is sometimes counted in months and years. The second constraint is fragmented IT systems; the third is the lack of administrative back office in medium and small hospitals, which have patients and investigators but no trial support centre of their own.
Direction
The department acts as a neutral collaboration platform for the market, bringing together sites, sponsors, CROs, investigators and public institutions. It follows the principle that what can be improved through our own competence and cooperation should be improved — through process standardisation, shared tools and open dialogue. Its strategic partner is the Polish Hospital Federation.
Why this is a role for a neutral party — a lesson from history
The problem is not new. In 2003 the United Kingdom introduced a model clinical trial agreement (mCTA) whose core text is used without modification, while only the schedules are tailored to the specific study [1]. In Poland, as early as 2008 the Association for Good Clinical Practice (GCPpl) pointed out that negotiating agreements with sites is one of the longest stages of trial preparation, and published a model agreement [2]. In the United States, according to an analysis by Vanderbilt University Medical Center, the ACTA master agreement, developed by some 25 institutions of the CTSA network, can cut average negotiation time from 55 to 22 days [3]. A later study found average savings of roughly 40 to 57 days when standard templates were used, and 16 days versus a historical average of 103 days in a multisite COVID-19 trial run on templates [4].
Despite this experience, in 2022 the author of a report on the Polish commercial clinical trials market pointed out that atypical demands from sites during negotiations — such as preliminary agreements before negotiations start or additional documents from sponsors — prolong the whole process by days, weeks or even months, attributing this to a lack of trust in the process [5]. In 2024 the Medical Research Agency (ABM) published tripartite and four-party academic model agreements as sets of provisions intended to standardise and accelerate contracting [6]. They are, however, models rather than binding documents, and are not a standard agreed with global sponsors of commercial trials.
Conclusion. Templates have existed, but none was negotiated with sponsors and hospitals at the same time. A sponsor cannot impose a template on hospitals, a single hospital has no negotiating power vis-à-vis a global sponsor, and a public body funding research is not a party to commercial agreements. The missing link is a neutral party that brings both sides to one table, develops the fixed part of the agreement and maintains it. Healthcare Poland is taking on this role — in partnership with the Polish Hospital Federation.
Two projects opening now
A standard clinical trial agreement. Healthcare Poland takes on the role of a neutral third party in developing, together with sponsors and industry organisations, a model for the fixed part of the site–sponsor agreement. Negotiations with a site could then focus mainly on the study budget rather than on the same legal clauses every time.
Virtual site — a virtual Clinical Trial Support Centre. A remote administrative back office for medium and small hospitals: contract routing, coordination with the ethics committee and the sponsor, documentation — with one working standard and a shared interface to hospital systems. Trials run inside the hospital, not outside it, keep knowledge and revenue in the public healthcare system.
The department’s principles: Just Culture and due diligence as a value-creating process, equal distance from all market participants, and data protection in line with GDPR. The Foundation does not recruit patients or give medical advice.
Sources
- Health Research Authority, Revised model clinical trial agreement (mCTA) – England: consultation.
- Biotechnologia.pl, Wzór umowy z ośrodkiem badawczym (in Polish), 4 Jan 2008.
- B. Snyder, Initiative speeds clinical trials contract negotiations, VUMC News, 5 Nov 2015.
- C.E. Lawrence et al., Quantitative assessment of the impact of standard agreement templates on multisite clinical trial start up time, Journal of Clinical and Translational Science 2023;7(1).
- Rynek Zdrowia, Badania kliniczne. Ośrodki miewają nietypowe żądania. „To efekt braku zaufania” (in Polish), 22 Feb 2022.
- Medical Research Agency (ABM), Wzory umów na realizację badania klinicznego – aktualizacja (in Polish), 29 Feb 2024.
