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Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act Introduced

Posted on February 21, 2012 by Matthew Tanner |

US Senator Kay Hagan (D-North Carolina) has proposed legislation that aims to provide faster access to new drugs that address unmet medical needs, significantly advance the standard of care, or target a serious or life-threatening disease or condition. The bill…

Another Take on the Cost of Developing New Drugs

Posted on February 21, 2012 by Matthew Tanner |

In an column published last week by the Fiscal Times, Merrill Goozner questions the $4-12B per-approved-drug price tag proposed recently by Forbes columnist Matthew Herper. Goozner, who has written a book on the subject, suggests the true cost of bringing one new…

Searching for alternatives to animal research?

Posted on February 20, 2012 by Matthew Tanner |

The USDA National Agricultural Library, Animal Welfare Information Center provides numerous database links to guide researchers and animal use boards in determining the best way to find alternative testing models to reflect their commitment to the 3Rs (Replacement, Refinement, and Reduction). One of…

New FDA Guidances for Clinical Trials

Posted on February 20, 2012 by Matthew Tanner |

FDA recently announced several new guidance documents that may be of interest to clinical investigators as well as administrators. Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information Agency recommendations for trials with live…

New Computerized System to Improve Patient Selection for Oncology Trials

Posted on February 20, 2012 by Matthew Tanner |

The Moffitt Cancer Center, an NCI-designated Comprehensive Cancer Center in Tampa, Fla., has developed a new computerized system to better match registered patients to oncology trials. Parameters such as disease, diagnosis, symptoms, demographics, family history, and the molecular profile of…

Programmatic Overlap

Posted on February 17, 2012 by Roger Wood |

In the US and many other nations, programmatic overlap of awards is generally to be avoided. This is clearly articulated by the NIH in their Grants Policy Statement description of Other Support associated with their Just-in-Time procedures. It is perfectly…

The Frightening Cost of New Drug Development

Posted on February 17, 2012 by Matthew Tanner |

Forbes blogger Matthew Herper suggests the true cost of bringing one new drug to market is $4-12 billion. The $1 billion figure frequently cited by the pharmaceutical industry does not take overall R&D spending into account, obscuring the impact of failed drug…

Therapeutic Misconception Remains Strong Among Clinical Trial Participants

Posted on February 17, 2012 by Matthew Tanner |

In a survey study led by researchers at Emory University, 89 of 95 respondents participating in a Phase I oncology trial misjudged their risk of experiencing adverse effects, their probability of receiving direct benefit, or both. Only 31 responded correctly to…

2013 Federal Budget Proposal Includes $2M Cut for OCR

Posted on February 17, 2012 by Matthew Tanner |

The US Office for Civil Rights would see its budget decrease slightly in fiscal 2013, even as its workload expands to include HIPAA breach notification under the HITECH Act. OCR is still operating under an interim version of the breach…

OHRP Extends Nomination Period for SACHRP

Posted on February 17, 2012 by Matthew Tanner |

The US Office of Human Research Protections is accepting nominations through March 16, 2012, to fill four seats on the Secretary’s Advisory Committee on Human Research Protections. Please see the Federal Register announcement for more information.