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• The incidence of investigator absence from supervising clinical trials is growing as more trials are being conducted, more professionals are speaking out and sponsors, CROs and regulatory agencies tracking it more actively. To address this problem, FDA and industry are taking steps to implement new processes, to train and educate clinical investigators, and to require more accountability from investigative sites.

Article 242: The Dismantling of ICSL

• Once an SMO market leader, ICSL exits the business due to a complex combination of financial, legal, operational and political problems. In its wake, ICSL leaves behind hundreds of millions of dollars in losses, disappointed investigative sites and investors. Comprehensive Neurosciences is expected to buy what remains of the ICSL site network.

• As American drug companies began to conduct more multinational trials in the mid 1980s, a golden opportunity seemed to present itself to American independent review boards (IRBs)-acting as the IRB of record for European sites. Since Europe had no harmonized ethical review system and also did not have a central agency to monitor decisions made by ethical review committees or enforce common standards, conditions seemed ripe for independent IRBs to play a major role there. Ironically, the conditions that created this opportunity have also acted as a hindrance. Western Institutional Review Board, based in Olympia, Wash., has been exploring the market's possibilities for more than a decade.

• More than 170,000 people are diagnosed with lung cancer each year and 150,000 people die of the disease annually. Unfortunately only 15% of lung cancer cases are diagnosed at an early stage; consequently, the survival rate for this type of cancer is quite low.