Poland has seen a dramatic increase in clinical trial activity over the last few years, to the point where some clinics are turning away studies.

Applications for new trials are coming in at a rate of around 400 per year, compared with fewer than 100 in 1997, said Grzegorz Litynski, senior regional manager for i3 Research, in a presentation at the recent 28th Annual Conference and Exhibition of the Institute of Clinical Research in Birmingham, UK. Clinics in key therapeutic areas such as onco-haematology are now “overflowing”, he added.

The vast bulk of these applications are coming from outside the country, as most of the indigenous pharmaceutical industry focuses on generics while Polish universities are generally constrained financially from running their own trials.

Cost is often cited as the primary motive for diverting clinical development from more established pharmaceutical markets to the so-called “ascending” regions of Central and Eastern Europe, Latin America, India, South East Asia and Africa. Investigator and other labour costs in Poland are generally a good deal cheaper than in Western Europe or the United States, Litynski acknowledged. But the main saving is on speed of processing: finishing a trial eight months earlier can save millions of dollars.

There are a number of other good reasons for running clinical trials in Poland, not least the size of its population – 38.6 million in 2004, with 66% concentrated in urban areas. Other immediate advantages include a single language, a centralised health system and a high prevalence of some diseases, such as metastatic breast cancer (often late-stage due to poor diagnosis), melanoma, prostate cancer, lung cancer and paediatric leukaemia (also often very advanced). Psychiatric disorders like untreated Alzheimer’s disease, where drug reimbursement is minimal and patients cannot otherwise afford therapy, are also widespread in Poland.

High rate of patient recruitment

Added to these benefits are a high rate of patient recruitment, as well as strongly motivated clinical investigators, highly educated clinical research staff and “very good quality” data, Litynski pointed out.

Recruitment is now a perennial bugbear for companies setting up clinical trials in Western Europe and the US. In another presentation at the ICR meeting, Dr Philippa Smit-Marshall, executive medical director for Europe and Asia Pacific at contract research organisation Pharmanet, noted that in the US only 3.7% of patients with a disease are estimated to have entered a clinical study, while recruitment targets were met in less than one third of the 114 trials conducted in the UK between 1994 and 2002.

The picture is very different in Poland, where patients are actually asking their doctors to take part in trials, Litynski observed. Recruitment often exceeds Western European levels several times over. Free medicines, superior medical care and additional diagnostic procedures such as X-rays are a significant incentive in this respect.

Typically the national health system in Poland reimburses only a minority of therapies and many hospitals are already running out of money this year, Litynski commented. There are parallel benefits for investigators, who secure access to modern techniques such as ratings scales for psychiatric disorders, while doctors taking part in trials can be reimbursed directly by CROs.

Hub for research expertise

Poland is also increasingly a hub of clinical research expertise. Some 60-70% of these researchers are medical doctors and many are educated at western universities, Litynski pointed out. Five years ago the country could only supply trial monitors but now it offers project directors, quality assurance managers and other key personnel. Nonetheless, finding experienced clinical research associates in the face of escalating demand remains a challenge.

The problem is exacerbated by available CRAs moving to other jobs or countries. Training programmes are expensive and there is traditional resistance to relocation in Poland. CROs address this latter dilemma through home-based working but pharmaceutical companies are generally not keen on the concept, Litynski said.

Other challenges include a long set-up period for clinical trials and a number of administrative restraints. That is not to say the regulatory environment for clinical trials in Poland has not improved. The country implemented the European Union’s clinical trials directive, 2001/20/EC, in April 2004, meaning study approvals are now subject to the legal deadline of 60 days. Moreover, an ordinance issued by the Polish health minister on 3 January 2007 introduced standardised application forms for ethics committee approval, which runs in parallel to regulatory clearance.

Nonetheless, there are sticking points. Once a clinical trial is approved, sponsors usually have to wait another 10-14 days for an import licence. The Ministry of Health also spends about 10 extra days validating clinical trial documentation. Moreover, sponsors have to supply all details of contracts with investigators and trial sites (including financial details) before they can embark on the approval process. It is because of these hurdles that local expertise is crucial to the successful conduct of clinical trials in Poland, Litynski insists.

All the same, the Polish sector is undoubtedly booming. So far Litynski sees little impact on this trend from the newer, and potentially cheaper, markets for clinical development in India, Latin America and Africa. That could change as the Polish zloty gains strength against western currencies. For the moment, though, the country is “overloaded” with trials, he says.