CenterWatch Monthly: April 2007 Issue
Healthy Pipeline of Clinical Trials in Russia
Russia's global clinical research market has grown substantially in the past five years. But, relative to Russia's population of nearly 143 million, there is enormous potential for future growth, given that only 42,000 patients were enrolled in global clinical trials in the country last year. FDA and EMEA have begun approving drugs with clinical trial data from Russian sites, a mark of quality. That, along with rapid patient enrollment, has helped Russia emerge as an attractive clinical research market. While clinical research has been conducted in the country since the 1990s, big pharma has only recently begun to regard Russia as a potential future market for their drugs.
Patient Recruitment Companies Branch Out
Drug sponsors increasingly turn to patient recruitment providers to both rescue trials that have failed to meet enrollment objectives and for strategic advice early in the drug development process. As patient recruitment companies have broadened their services, a few have expanded into CRO-type services, such as standard protocol monitoring of trials. At least one patient recruitment company, BBK Worldwide, has split off a separate company, TCN e-Systems, which is a software platform that empowers sponsor companies to take greater control of their patient recruitment processes in-house. Other patient recruitment vendors have developed proprietary software.
EFGCP Addresses Ethics Committee Variability, Calls For Changes to Directive
Any biopharmaceutical company that has conducted a multinational clinical trial in the European Union (EU) knows that the ethics committee systems there vary a great deal, creating delays and confusion.The question is: Why are there so many differences among ethics committee systems in the EU even after the Clinical Trials Directive has been implemented?
Eye On Leukemia
Leukemia is a general term for cancer of the bone marrow blood cells. It includes acute and chronic forms of myelogenous and lymphocytic leukemia, based on which type of white blood cell is involved. Acute leukemia is rapidly progressive, leading to the accumulation in the marrow and blood of cells that are primitive, meaning still not fully developed or differentiated. Chronic leukemia progresses more slowly, allowing growth of greater numbers of more mature or developed cells. In acute leukemia, the cancerous blood cells are too immature to function, whereas in chronic leukemia, white blood cells present in excessive numbers retain some of their usual function.
CenterWatch has identified a pipeline of 20 drugs in various stages of development for leukemia. Thanks to new advances in molecular biology, several of these are monoclonal antibodies or antisense molecules with leukemia-specific targets. Others are new twists on conventional chemotherapy agents acting to suppress cancer cell replication and growth.
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