Japan’s Global Clinical Trials Initiations Skyrocket
New global clinical trial initiations increased dramatically from 2006 to 2007 in Japan. No other country in Asia experienced anywhere near such an increase in new global clinical trial initiations. Though Japan has made great strides at every level—government, site, sponsor, CRO and patient—to become more attractive for global clinical trial initiation, the country’s work is far from over. In fact, it is just beginning.
2008: Strong Start, Tough Finish
2008 began with high expectations for growth in the clinical trial space, but difficult economic conditions led many companies to slow non-organic growth and cut costs. In spite of the challenges brought on by the economic and regulatory climate—or perhaps because of them—some emerging markets within the industry thrived. Companies faced heightened transparency and disclosure requirements as regulators, congressional investigators, the media and even patients increased their scrutiny of drug development practices.
ICH E9 a Decade Later—What’s Working, What’s Not
Experts are divided as to whether the original guideline International Conference on Harmonisation (ICH) E9, adopted in February 1998, needs further revision. The harmonized biostatistical tool that describes essential considerations for the design and analysis of clinical trials—especially the confirmatory, or hypothesis-testing, trials that are the basis for demonstrating effectiveness—is considered by the majority of statistical experts to be as relevant today as it was a decade ago. However, experts agree that more needs to be done to codify agreement on controversial subjects such as adaptive designs, missing data imputation methods, and dynamic allocation.
Eye On: Adverse Effects of Chemotherapy
Although many currently available chemotherapeutic agents are effective in prolonging survival in cancer patients, they often do so at the risk of poor tolerability and toxicity. Acute complications may include chemotherapy-related nausea or vomiting (CINV), diarrhea and mucositis, whereas chronic complications may include neutropenia or anemia due to bone marrow suppression, or nerve damage manifest as hearing loss or neuropathy.
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