With more than 19 years of experience in conducting CNS trials, we are now seeing that
studies in Eastern Europe are becoming more and more popular among sponsors worldwide.
Aside from cost-effectiveness and high incidence rates in CNS disorders, there is another important factor that makes clinical research in EE even more attractive. It is lower placebo response rates in patients.
Placebo response in CNS trials is substantial and increasing. High placebo response rates have become an important problem, especially in the trials taking place in the USA.
Last year, Intra-Cellular ran two identical studies in Bipolar Depression. The 401 trial was entirely conducted in the U.S. and did not meet the primary endpoints due to the high rate of placebo response. Intra-Cellular announced the positive top-line results with significantly lower placebo response rate for the 404 trial, which was conducted globally with most patients recruited in Eastern Europe.
Another global study in Schizophrenia was conducted by ACADIA Pharmaceuticals and showed consistent improvement in psychotic syndromes. Even though it failed to meet the primary endpoints,
the analysis by region showed consistent positive results for the European population including patients from Bulgaria, Czechia, Hungary, Poland, Serbia, Ukraine and Russian Federation.
Patients’ high placebo response calls the value of many CNS medications into question. Ever since the issue emerged, the sponsors have been in search for methods to mitigate it.
Many of them have found it useful to diversify the trial by adding regions with potentially lower placebo response rates among patients. One of such regions is Eastern Europe, where GCT established full-service operations and have been running clinical trials since 2001.
GCT is your partner in clinical trials in Eastern Europe because it combines global reach with local expertise. Both GCT CEO, Dr. Eugene Selivra and GCT President, Dr. Jeffrey Apter are trained psychiatrists with 50+ years of combined experience in clinical research. Dr. Jeffrey Apter is a Key Opinion Leader (KOL) in Depression and Alzheimer’s Disease. Moreover, GCT has close ties with the international CNS community and is an expert in the latest innovations in CNS clinical research.
“AbbVie partnered with Global Clinical Trials in the conduct of Alzheimer’s disease clinical trials in
sites across Eastern Europe. This partnership proved to be invaluable. Trial results have been published; demonstrating statistical separation of positive control (donepezil) from placebo, low placebo response, and low statistical variability on endpoints, including the primary endpoint,” – George Haig, Pharm.D., former Group Project Leader at AbbVie.
Are you planning a clinical trial in the CNS therapeutic area? Contact our BD team at firstname.lastname@example.org with any questions or for a free feasibility analysis for your planned clinical program.