• Regulatory NewsRegulatory News

    Novel Trial Endpoints Generated by Mobile Tech: CTTI Offers Recommendations

    The Clinical Trials Transformation Initiative (CTTI), a public-private partnership established by Duke University and the US Food and Drug Administration (FDA), on Monday released new recommendations on developing novel clinical trial endpoints generated by mobile technology. Such mobile technology can offer new ways to collect objective measurements of clinical trial participants as they go about their daily lives. And though the use of such novel endpoints, whi...
  • Regulatory NewsRegulatory News

    CTTI Offers Recommendations for Pediatric Clinical Trials for Antibiotics

    The Clinical Trials Transformation Initiative (CTTI) has released a set of recommendations it says will improve the use of antibiotics in children. According to CTTI, a public-private partnership aimed at improving the quality and efficacy of clinical trials, challenges in enrolling and completing pediatric clinical trials for antibiotics leads to a situation where such drugs are used in children despite lacking adequate labeling for pediatric populations. Furthermore, ...
  • Regulatory NewsRegulatory News

    FDA to Put Almost $38 Million Behind Effort to Improve Clinical Trials

    The US Food and Drug Administration (FDA) plans to pour as much as $37.5 million into an initiative intended to improve the quality of clinical trials, the agency has announced. In a 22 May 2014 Federal Register announcement, FDA said it plans to grant the Duke Translational Medicine Institute (DTMI) $7,500,000 per year for as many as five years in the hopes that  the "clinical trial enterprise" can be improved to better provide regulators and industry with data to dri...
  • Study: Clinical Trials Lag in Enrollment of Children

    • 02 October 2012
    Are the pharmaceutical industry and the National Institutes of Health doing enough to enroll children in clinical trials? No, claims a new study published in the journal Pediatrics and supported by the Clinical Trials Transformation Initiative (CTTI), an organization that partners with the US Food and Drug Administration (FDA) and numerous other government agencies. The study, " Status of the Pediatric Clinical Trials Enterprise: An Analysis of the US ClinicalTrials.go...