Tufts University Center for the Study of Drug Development

Gosse, M.E., Manocchia, M., and Nelson, T.F., Overview of US Pharmaceutical Development, 1980-1994, Tufts University Center for the Study of Drug Development, May, 1996. Grabowski, H.G. and Vernon, J., The search for new vaccines the errors of the vaccines for children program, American Enterprise Institute, Washington, 1994. 

Tufts [University] Center for the Study of Drug Development, Tufts Center for the Study of Drug Development Pegs Cost of a New Prescription Medicine at 802 Million, press release, November 30, 2001. 

The two studies by Hansen (175) and DiMasi (109) are based on samples of NCEs frost entering human testing in specified time periods. The sample of NCEs for each study was selected from a set of data on NCEs constructed and maintained by the Tufts University Center for the Study of Drug Development (CSDD) from an ongoing triennial survey of over 40 pharmaceutical fins. The early study examined approximately 67 NCEs, discovered and developed by 14 U.S. pharmaceutical firms that first entered human trials between 1963 and 1975. The second study... 

SOURCE Office of Technology Assessment, 1993, based on data supplied by Tufts University Center for the Study of Drug Development from its database of NCEs reported by 41 pharmaceutical firms. 

Out-of-pocket and capitalized costs per approved drug. (From Tufts University Center for the Study of C)rug Development.)... 

Center for the Study of Drug Development, Tufts University Outlook 2004 and other publications. 

Courses/ workshops/ and meetings are offered by the Pharmaceutical Education and Research Institute (PERI) (46)/ Drug Information Association (DIA) (47)/ Center for Drug Development Science (CDDS) at the University of California/ San FranciscO/ Washington/ D.C. Center (48)/ Tufts Center for the Study of Drug Development (CSDD-Tufts) (49)/ the National Institutes of Health (50)/ the FDA s Center for Drug Evaluation and Research (CDER)/ and other organizations. 

Second, the percentage of US investigators participating in clinical trials has always been low, in the range of 5% of physicians, and this number seems to be declining. A recent study from the Tufts Center for the Study of Drug Development indicates that only 3% of US board certified physicians are principal investigators (Tufts University, 2005). 

These data were obtained in April 2002 by Mom Janice Reichert at the Tufts University Center for Study of Drug Development in Boston, Massachusetts. For further trends and analyses in this regard, see the Tufts Center s Inc pact Report, Vol. 3, Nov/Dec 2001. 

TUfts University, Center for Study of Drug Development, unpublished data provided to the Office of Technology Assessment, U.S. Congress, Washington, DC, 1990. 

Estimates from a recent study by the U.S. Center for Drug Development at Tufts University place the cost of research and development for a new chemical entity at 231 million in 1987 dollars, and the time required to bring a product to market at 12 years. Only five of4000 compounds screened in preclinical testing survive to human testing, and only 20 percent of these obtain FDA approval. 

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