Please find hereunder exemplary eight clinical trials conducted at the IPREE clinical sites
The first trial was a phase I safety trial in 24 patients with primary hypertension and wide-angle glaucoma. Due to restrictions in the in- and exclusion criteria and restrictions in concomitant medication, the recruitment of these patients turned out to be extremely difficult. The trial was started in Germany in four centres (three ophthalmologists with private praxis and one ophthalmologic university centre). 11 patients were recruited after 15 month. Two of these patients were screening failures. After the decision was made to open a fifth centre at the IPR-EE clinical site in Ukraine., 15 suitable patients were recruited and screened within three weeks. The patients were included into the trial en bloc and the clinical part of the trial was finished within two months. The recruitment at the IPR-EE clinical site in Ukraine was eased by the fact that many hypertensive patients with wide-angle glaucoma were untreated neither for hypertension nor for glaucoma. So the problem of concomitant medication was reduced.
The second trial was a cardiac safety trial in middle aged female subjects > 45 years of age. The trial protocol requested registration of more than 1,000 ECGs under strictly controlled conditions to guarantee validity of the primary parameter QTc. In addition more than 2,300 blood samples were taken, handled and shipped deeply frozen to a laboratory outside Ukraine. There was no missing sample and only two ECGs were missing at the end of the trial. The trial participants were recruited and screened within three weeks. The subjects were included in subgroups of six patients and started the clinical part separated by two days from each other. The results of the trial were presented at the annual meeting of the American Society of Hypertension in May 2003 in New York, USA.
The third trial was a multi-centre trial in which the IPR-EE clinical site in Ukraine was one out of 165 active centres in whole Europe. The protocol requested patients with unstable bladder syndrome. All other forms of incontinence were excluded. A challenge, which can only be taken over by experienced urologists. In addition to standard urological investigations, the selection of patients also requested a cystometric investigation. The clinic was equipped with one of the latest cystometric devices available on the market. From the beginning of the clinical phase on, the IPR-EE clinical site in Ukraine was amongst the first five centres with the best recruitment rate. This success is based on the support of a highly motivated and quality-oriented urologist, Prof. Valery Zaytsev who was integrated in the clinical team of the IPR-EE clinical site in Ukraine as sub-investigator. At the final investigator’s meeting IPR-EE clinical Site in Ukraine was awarded for best recruitment and quality of clinical data.
The fourth trial again was a cardiac safety trial in 24 patients with myocardial infarction documented by pathological Q-wave in any of the 12 standard ECG leads, a patient population which is at high cardiac risk.
 |
It was the merit of the cardiologist Prof. Semen Biletski, a member of the Bukovinian State Medical University to select 60 suitable patients within six weeks, with the carefulness of a responsible sub-investigator. So on achieving approval to conduct the trial from local authorities, 60 patients were ready for screening and the most suitable candidates could be selected. It was then the professional clinic team supervised by the quality control team who managed to document more than 2,000 ECG recordings at rest and under standardised exercise conditions, and to take, handle and ship more than 2,400 blood samples. No samples were lost, and three ECGs were missing at the end of the trial. The monitoring team checked a documentation of approximately 13,000 CRF pages and attachments by 100%.
The fifth trial was a basic investigation on the validity of QTc interval measurements. The validity of QTc interval measurements was investigated at different standardised resting and exercise conditions in healthy male subjects. Some standards for reproducible ECG recording could be ruled out which were so far not available in published literature. Parts of these results gained a strong echo from present cardiologists, clinical pharmacologists and members of German Health Authorities at the AGAH annual meeting in March 2003 at Bonn, Germany. These basic investigations will continue and several publications are planned.
The sixth trial was a pharmacokinetic trial in patients with different stages of hepatic impairment. The patients were classified according to the Child Pugh classification in Child Pugh A, B, and C. Especially the Child Pugh C class is very
difficult to select for clinical trials, as their clinical status is often very unstable. The IPR-EE clinical site in Ukraine recruited and completed N = 8 suitable Child Pugh A, B and C patients respectively and N = 8 gender, age and body weight matched healthy subjects within less than four months.
The seventh trial was a pharmacokinetic trial in patients with severe renal impairment (CLCR < 30 ml/min) in comparison to age, MBI and gender matched healthy subjects (N = 8 in each group). The IPR-EE clinical site in Chisinau, Moldova recruited and completed these patients and the matching controls in three weeks.
The eighth trial was again a pharmacokinetic trial in patients with different stages of hepatic impairment. The patients were classified according to the Child Pugh classification in Child Pugh A, B, and C. The IPR-EE clinical site in Ukraine recruited and completed N = 8 suitable Child Pugh A, B and C patients respectively and N = 8 gender, age and body weight matched healthy subjects again within four months.