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Matthew Lehman Of SPRI Clinical Trials Speaks On Designing Trials For Success At The Trout Group Investor Relations Seminar
In designing and conducting clinical trials, it is critical to meet FDA objectives while preventing program "drift," according to Matthew Lehman, chief operating officer of SPRI Clinical Trials-Global, LLC in his remarks at a recent seminar for biotechnology companies.
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Sosei And Vectura Announce Start Of Phase III Clinical Study With NVA237
Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) and Vectura Group plc ("Vectura"; LSE: VEC) announce the commencement of a Phase III clinical study by Novartis, with NVA237, a once-daily, long-acting muscarinic antagonist (LAMA) for the treatment of chronic obstructive pulmonary disease (COPD). NVA237 is a dry powder formulation for oral inhalation of glycopyrronium bromide, a LAMA with a rapid onset of activity. The study has now appeared on clinicaltrials.gov and will be recruiting in the next few weeks when the first patient first visit will trigger a $7.5 million milestone payment to both Sosei and Vectura.
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Shanghai To Relax One-Child Policy As China Faces Aging Population, Shrinking Work Force
Nearly three decades after China implemented its one-child policy, the city of Shanghai is planning to encourage young couples to have a second child in an effort to address the country"s aging population and shrinking work force, the New York Times reports. The city"s plan is the most public effort made by the government to counteract a program that is "considered both a tremendous success and a terrible failure," the Times reports. The policy has managed to keep population growth under control but also has led to forced abortions, according to the Times.The country is not abandoning the one-child policy, which applies mostly to residents in urban areas. Rather, the government is allowing more exceptions to the rule, with Shanghai -- where about 22% of its 20 million residents are older than age 60 -- leading the effort. China as a whole faces a similar problem seen in Shanghai, the Times reports. About 8% of the country"s population was older than age 65 in 2006. That figure is expected to increase threefold by 2050 to about 322 million people, or nearly 25% of the population, according to the United Nations.In Friday"s issue of China Daily, Xie Lingli, director of the Shanghai Population and Family Planning Commission, was quoted as saying, "We advocate eligible couples to have two kids because it can help reduce the proportion of the aging people and alleviate a work force shortage in the future." City officials plan to visit homes, pass out leaflets, and offer counseling and financial incentives, the Times reports. Current exceptions to the one-child policy are in place for ethnic minorities and rural residents, who can have a second child if the first child is a girl. Couples made up of two parents who have no siblings have always been allowed to have a second child and are now being encouraged to do so (Barboza, New York Times, 7/24).
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Genetic Factors Implicated In Survival Gap For Breast, Ovarian Or Prostate Cancer

A new finding reveals that African-American patients with breast, ovarian, and prostate cancer tend to die earlier than patients of other races with these cancers, even when they receive identical medical treatment and when socioeconomic factors are controlled for. The finding, an analysis of almost 20,000 patient records from 35 clinical trials, points to biological or genetic factors as the potential of the survival gap. Dawn Hershman, M.D, M.S., a Columbia University Medical Center oncologist whose research is dedicated to examining racial and ethnic disparities in cancer outcome and in cancer survivorship, was the senior author of the research published online by the Journal of the National Cancer Institute (JNCI). The study analyzed patient records from clinical trials - going back as far as 1974 - conducted by the Southwest Oncology Group (SWOG). The investigators conducted an analysis that controlled for comparable treatment, disparities in tumor prognosis, demographics, and socioeconomic status, and found no statistically significant difference in survival based on race for a number of cancers - including lung, colon, lymphoma, leukemia and multiple myeloma. However, African-American patients with breast, ovarian, or prostate cancers - the gender specific tumors - were found to face a significantly higher risk of death than did other patients, ranging from 21 percent higher for those with prostate cancer to 61 percent higher for ovarian cancer patients. The poorer outcome for African-American cancer patients was supported by separate data published last month in the Journal of Clinical Oncology (JCO), which found that disparities in breast cancer survival based on race persisted even after adjusting for differences in treatment. That analysis of data from 634 breast cancer patients who participated in two SWOG-conducted trials was led by first author Dr. Hershman. Findings revealed that African-American women received similar dose intensity and cumulative dose as the Caucasian breast cancer patients, but were more likely to discontinue treatment early or experience treatment delay. In addition, African-American women had lower white blood counts, but no increase in infections complications. While Dr. Hershman and her team adjusted for these specific treatment related factors and other known predictors of outcome, such as age, hormone receptor status, stage, and treatment, African-American women still faced a lower rate of survival. "The findings from these two studies are important as they suggest a possible role for biologic factors such as genetics, hormonal factors, comorbid conditions and tumor biology in cancer disparities. A better understanding of all the factors that contribute are critical, so that continued progress can be made toward reducing cancer mortality for patients of all races and ethnicities," says Dr. Hershman, assistant professor of medicine and epidemiology at Columbia University Medical Center and co-director of the breast cancer program at the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian Hospital/Columbia University Medical Center. "There may be differences in genetic factors by race that alter the metabolism of chemotherapy drugs or that make cancers more resistant or more aggressive. We are now starting research to determine the role of these factors in this disparity." "When you look at the dialogue about the issue of race and cancer survival that has gone on over the years, it always seems to come down to general conclusions that African-Americans in part have poorer access to quality treatment, may be diagnosed in later stages and may not have the same standard of care delivered as Caucasian patients, leading to a disparity in survival," says Kathy Albain, M.D., of Loyola University"s Cardinal Bernardin Cancer Center, lead, and senior author of the JNCI and JCO papers, respectively. "The good news is that for most common cancers, your survival is the same regardless of race. But this is not the case for breast, ovarian, and prostate cancers." "The need to address the racial disparities in cancer survival outcomes - both sociological and biological - has never been more urgent," says Dr. Hershman. "With the incidence of cancer among minorities predicted to double in the next two decades - while comparable incidence among whites is only expected to rise 31 percent - this is a crucially important public health issue to understand all the factors that alter survival outcomes." Elizabeth Streich Columbia University Medical Center


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