Bio-Imaging has refined its processes to support the rigorous requirements of clinical trials, including the optimization of methodologies used to perform tumor measurements in oncology studies. The demand for more objective and quantitative evaluation of medical imaging data is being driven by the need for more valid surrogate measures of treatment efficacy.
Oncology is just one of many areas where medical images are playing and increasingly important role.
In march 1996, FDA issued an initiative entitled Reinventing the Regulation of Cancer Drugs . In March 1997, FDA issued a Draft Guidance Document entitled Providing Clinical Evidence Of Effectiveness For Human Drug And Biological Products . This guidance defined alternatives to the conventional requirement of two independent pivotal efficacy studies. One such alternative includes conducting a single pivotal efficacy study with prospectively identified primary or secondary endpoints, which represent beneficial, but different effects. It has been shown that, when clinically appropriate, imaging endpoints may serve as either primary or secondary endpoints.