Approval Process
Poland became EU member in 2004. The legislation has been almost fully harmonized with EU, including the Drug Law.
- realistic start-up time: 5 months
Recruitment Potential
Poland is the largest market in clinical trials in Europe (20% share in 2009). Oncology and cardiology (48% of all trials) are the most often tested therapeutic areas. A population size of 38 million, as well as patients’ willingness to participate in clinical trials, make the recruitment rates significantly higher than in Western Europe or the USA. Due to limited reimbursement budget, both pre-treated and treatment-naïve subjects are available.
Poland has the second highest incidence rate of lung and larynx cancer in the EU.
Estimated deaths per 100,000 population by cause (higher than world/European average):
| Diseases | Poland | World Average | Europe Average |
|---|---|---|---|
| Cardiovascular diseases | 464.8 | 240.9 | 465.2 |
| Neoplasms | 248.1 | 222.1 | 236.2 |
| Neurological conditions | 47.2 | 27.4 | 59.5 |
| Digestive diseases | 45.9 | 32.0 | 30.9 |
| Respiratory infectious | 29.8 | 43.6 | 28.9 |
| Mental and substance use disorders | 10.9 | 4.3 | 11.1 |
Data from World Health Organization
Investigators and Sites
With over 1,200 sites (including over 50 university hospitals and medical institutes), Poland is ranked 10th in the world and 1st among emerging markets in terms of number of clinical trials sites. Both, public and private hospitals and outpatient clinics are fully equipped and offering the highest standard of treatment and diagnostic procedures.
The availability of investigational sites at academic centers located in large cities, and the presence of well-educated investigators delivering high quality data in accordance with current ICH-GCP standards are some of the major factors which make Poland attractive for clinical research.
Most of the Polish CRAs are physicians, pharmacists, biologists or nurses, which leads to excellent relations with the investigators and high quality of collected data.