CenterWatch Monthly February 2008 Issue
Friday, February 15, 2008
Site Training on EDC Improves
According to a new Center-Watch training survey, more than half of investigative site staff indicated that the effectiveness of training on electronic data capture (EDC) software has improved during their career. Though training has im-proved, complexities remain. Nearly half of CenterWatch training survey respondents indicated they must learn to use at least five different EDC programs.
The Ethics of Subject Payment
Offering subjects money to participate in studies is a common practice in biomedical research. Payments can enhance recruitment but they can also generate ethical controversy. The chief ethical concern with offering subjects money is that this may be an undue influence that compromises their ability to assess the benefits and risks of participation. Phase I trials offer the highest payment, with an average of nearly $500 per trial, but payments per healthy volunteer can total thousands of dollars.
Revolutionary Public-Private Partnership for Early Phase Trials Established in France
The Centre Hospitalier Universitaire (CHU) de Caen, a university teaching hospital and the largest hospital in the West of France, and Therapharm, a large, private contract research organization founded in 1980, have joined forces to form the first public-private partnership to conduct early phase clinical research in France. The clinical research center is called Centre de Recherche Clinique-Basse Normandie (CRC-BN). The center conducts phase I and II clinical trials that are industry-sponsored, investigator-initiated and government-sponsored.
Eye On: Tropical Diseases
Tropical diseases run the gamut of bacterial, viral and parasitic infections from those commonly encountered, such as travelers’ diarrhea, to those endemic in underdeveloped nations with primitive living conditions, to rare but lethal infections potentially employed as bioterror agents. CenterWatch has identified a pipeline of 19 drugs in various stages of development against tropical diseases related to bacterial, viral and parasitic infections. Some of these drugs are vaccines and prophylactic agents, whereas others address treatment of active infections.
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