Now showing items 1-10 of 10

    • 5-α reductase inhibitors and prostate cancer prevention: where do we turn now? 

      Hamilton, Robert J; Freedland, Stephen J (BMC Med, 2011-09-15)
      With the lifetime risk of being diagnosed with prostate cancer so great, an effective chemopreventive agent could have a profound impact on the lives of men. Despite decades of searching for such an agent, physicians still ...
    • Compliance with results reporting at ClinicalTrials.gov. 

      Anderson, Monique L; Chiswell, Karen; Peterson, Eric D; Tasneem, Asba; Topping, James; Califf, Robert M (N Engl J Med, 2015-03-12)
      BACKGROUND: The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials ...
    • Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations. 

      Rockhold, FW; Enas, GG (Stat Med, 1993-03)
      The characteristics of data monitoring and the need for the use of data monitoring committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government. Data monitoring ...
    • Developing drugs for developing countries. 

      Ridley, David; Moe, Jeffrey (Health Aff (Millwood), 2006-03)
      Infectious and parasitic diseases create enormous health burdens, but because most of the people suffering from these diseases are poor, little is invested in developing treatments. We propose that developers of treatments ...
    • Economic return of clinical trials performed under the pediatric exclusivity program. 

      Li, Jennifer; Eisenstein, Eric; Reid, Elizabeth; Mangum, Barry; Schulman, Kevin; Goldsmith, John; Murphy, M Dianne; ... (10 authors) (JAMA, 2007-02-07)
      CONTEXT: In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric ...
    • Issues in regulatory guidelines for data monitoring committees. 

      DeMets, David; Califf, Robert; Dixon, Dennis; Ellenberg, Susan; Fleming, Thomas; Held, Peter; Julian, Desmond; ... (19 authors) (Clin Trials, 2004)
      As clinical trials have emerged as the major research method for evaluating new interventions, the process for monitoring intervention safety and benefit has also evolved. The Data Monitoring Committee (DMC) has become the ...
    • Priorities for the Priority Review Voucher. 

      Ridley, David B (Am J Trop Med Hyg, 2017-01-11)
      The U.S. Congress created the priority review voucher program in 2007 to encourage development of drugs for neglected diseases. Under the voucher program, the developer of a drug for a neglected or rare pediatric disease ...
    • Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities. 

      Buckler, Andrew J; Bresolin, Linda; Dunnick, N Reed; Sullivan, Daniel C; Aerts, Hugo JWL; Bendriem, Bernard; Bendtsen, Claus; ... (41 authors) (Radiology, 2011-06)
      Quantitative imaging biomarkers could speed the development of new treatments for unmet medical needs and improve routine clinical care. However, it is not clear how the various regulatory and nonregulatory (eg, reimbursement) ...
    • Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future. 

      Grabowski, Henry G; Guha, Rahul; Salgado, Maria (Health Aff (Millwood), 2014-06)
      In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing ...
    • Returns to R&D on new drug introductions in the 1980s. 

      Grabowski, HG; Vernon, JM (J Health Econ, 1994-12)
      This study finds that the mean IRR for 1980-84 U.S. new drug introductions is 11.1%, and the mean NPV is 22 million (1990 dollars). The distribution of returns is highly skewed. The results are robust to plausible changes ...