Thriving Synexus sees Ukraine as ‘key market’ for growth in the CEE
19 Jul 2010
Synexus, the world’s largest multi-national company dedicated to the recruitment and running of clinical trials took over its first site in Kiev at the world renowned Centre for Radiation Medicine in January this year when it finalised its acquisition of ClinPharm.
ROADMAP is a randomized, double-blind, placebo-controlled, parallel-group, multi-center Phase III study being conducted at 262 collaborating centers in 19 European countries. The primary goal of the study is to test the hypothesis that treatment of T2DM patients with 40 mg of olmesartan medoxomil will prevent or delay the occurrence of microalbuminuria in comparison to a regimen that excludes agents that directly block the RAS. The secondary objective is to test the hypothesis that treatment with olmesartan medoxomil has a positive effect on cardiovascular and renal morbidity and mortality.
The study involves 4,449 men and women with T2DM with normoalbuminuria (less than or equal to 35 mg albumin/g urine creatinine for women and less than or equal to 25 mg albumin/g urine creatinine for men) at the outset, and who have at least one additional cardiovascular risk factor, including patients being treated for hypertension. Patients were randomized to receive 40 mg of olmesartan medoxomil or placebo for an average of five years. Patients with hypertension were also treated at the investigator's discretion with diuretics, alpha- or beta-blockers or calcium channel antagonists to achieve a target BP of <130/80. Patients requiring treatment with an ARB or ACEi were withdrawn from the study.
15 medical universities and academies
3 academies of post graduate medical education
33 scientific medical institutes
Many pharmaceutical companies located in Ukraine
Primary and secondary care is largely organised around large hospitals and cover large patient populations
Centralised structure with vertical referral scheme
No nationwide insurance scheme for health reimbursement
Clinical trials often provide a much better standard of care for a patient than the national health services – incorporating not only the study medication, but a full set of health care services including free lab testing, diagnostics…..For many people, joining a trial may be the only way to benefit from the most up-to-date diagnostic procedures and potentially effective treatments….
Number of clinical trials – significantly increased since the mid-1990’s from 6 in 1996 to 125 trials in 2005. Potential capacity remains huge.Chief Executive of Synexus, Michael Fort says growth for 2010 and beyond is already looking very encouraging: “Interest from sponsors to use all of our sites in the CEE has been incredibly strong so far this year, but I am particularly impressed with the levels of interest in Ukraine. We have a number of very highly qualified investigators at the site in Kiev who specialise in diabetes, immunology and neurology and who have excellent relationships with colleagues in primary and secondary care. This is proving key to working with sponsors to set up trials here.”
The Kiev site is presently in discussions about its involvement in a number of international type 2 diabetes trials, and is predicted to recruit well in excess of its targets far more quickly than comparable sites in Western Europe and the UK. Jane Restorick, Chief Operating Officer for Synexus expects pharma and CROs to place more studies in the Ukraine and take advantage of the largely treatment naïve population there: “In Kiev alone we have a population in excess of 2.5 million. Our site is part of an extremely modern and highly regarded hospital where specialist consultants have very positive relationships with our investigators. On top of this, we are working with patients who are keen to join clinical trials so that they can benefit from higher standards of healthcare than they might otherwise afford. The drop out rates here are considerably lower than in Western Europe and the doctor-patient relationship is generally stronger and with higher levels of respect and trust.”
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Vane Percy & Roberts
Simon Vane Percy
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