Drugmakers are racing to test their wares in this Central European nation, thanks to an unusual mix of poor, sick people and, conversely, some highly educated research professionals.

Applications for new trials are running at around 400 per year, compared with fewer than 100 in 1997. The vast majority are being conducted by companies from the US and Western Europe, but some clinics are turning them away. Certain sites are “overflowing,” says Grzegorz Litynski of i3 Research, who spoke at an industry conference in the UK.

The big savings is fast completion time, but there are other reasons. The population is large and two-thirds are concentrated in urban areas, one language dominates, the national health system reimburses few meds, and hospitals are running out of money. Lured by free meds, medical care and diagnostic procedures, Poles are clamoring to be enrolled.

And many have good reason: there’s a high prevalence of such diseases as metastatic breast cancer (often late-stage due to poor diagnosis), melanoma, prostate cancer, lung cancer and pediatric leukemia. Psychiatric disorders like untreated Alzheimer’s disease, where drug reimbursement is minimal and patients cannot otherwise afford therapy, are also widespread.

But there are sticking points. The Polish health minister just introduced standardized forms for ethics committee approval and also spends about 10 extra days validating clinical trial documentation. And sponsors have to supply all contract details with investigators and trial sites, including payments, before anything can happen.

These hurdles are good things. Everyone wants to lower costs and develop new products more quickly, but this scenario also raises red flags about full disclosure of important info to patients. No one should get hurt in the rush to develop a new med, not even willing guinea pigs.

Source: PharmaTimes[tags]Clinical Trials, Poland[/tags]