Preview

Symptomatic Benefit Endpoints

Satisfactory Essays
Open Document
Open Document
80 Words
Grammar
Grammar
Plagiarism
Plagiarism
Writing
Writing
Score
Score
Symptomatic Benefit Endpoints
Symptomatic benefit endpoints such as time to pain, time to weight loss and time to performance status loss are common as secondary and sometimes primary endpoints. FDA encourages the use of these as they do represent clinical benefit and are often reasonably quickly maturing.
With the recent dramatic increase in research in targeted therapies has come an increase in use of biomarker endpoints in all phases. These are not generally considered to be clinical benefit endpoints by the regulatory agencies.

You May Also Find These Documents Helpful

  • Good Essays

    MS-DRGs had a single goal to which was to improve the ability to recognize the severity of…

    • 593 Words
    • 3 Pages
    Good Essays
  • Satisfactory Essays

    COM 220 Entire Course

    • 483 Words
    • 4 Pages

    WEEK 5 INCORPORATING STATISTICS.doc COM-220 WEEK 6 CHECKPOINT.doc COM-220 WEEK 6 DQS.doc COM-220 WEEK 7 PEER REVIEW 1.doc…

    • 483 Words
    • 4 Pages
    Satisfactory Essays
  • Satisfactory Essays

    Case Study Grid

    • 581 Words
    • 3 Pages

    For each nursing diagnosis, state two desired outcomes using NOC criteria. Desired outcomes must be patient-centered and measurable within an identified timeframe.…

    • 581 Words
    • 3 Pages
    Satisfactory Essays
  • Good Essays

    Clinical outcomes include improvements in the quality of care, a reduction in medical errors, and other…

    • 818 Words
    • 4 Pages
    Good Essays
  • Satisfactory Essays

    Limitations of the Minami et al. Forum 1 Journal Article called for caution in interpretation of the results.…

    • 707 Words
    • 3 Pages
    Satisfactory Essays
  • Good Essays

    An Agency for Healthcare Research and Quality resource which includes an annotated compilation of the most recent and important news, research, tools, and conferences in patient…

    • 826 Words
    • 4 Pages
    Good Essays
  • Powerful Essays

    Asco: Masitin Entry

    • 1038 Words
    • 5 Pages

    The ASCO-GI conference has come and gone, and still key questions remain unanswered about the apparently stellar result from last year’s phase III pancreatic cancer study of AB Science’s masitinib. The company had earlier stated that at ASCO-GI it would reveal details about the robustness of the post-hoc analysis and the genetic biomarker that seems to correlate strongly with masitinib’s efficacy. But it now says that these will not be disclosed until later – a remarkable level of secrecy given that masitinib is already awaiting EU approval. The lingering unknowns, and AB’s refusal to shine a light on them, speak volumes about the project’s likelihood of a first-pass approval. On Friday AB presented a poster on the phase III study, adding masitinib on top of gemcitabine in 353 pancreatic cancer patients, at ASCO-GI. The company’s stock had surged on the announcement of topline data from this trial last October, but no detailed analysis was offered then, and little more is forthcoming now (AB Science's dog drug data raise more questions than answers, October 31, 2012). Trial failed Although the trial had unequivocally missed its primary endpoint, what had caused the excitement was the revelation that two subgroups – patients with pain above a certain threshold and those with a particular genetic marker – had done particularly well on masitinib, boosting median overall survival versus standalone gemcitabine with barely believable p values of 0.010…

    • 1038 Words
    • 5 Pages
    Powerful Essays
  • Good Essays

    clinical processes and Stage 3- Improved outcomes. Each of these stages has it’s own meaningful use criteria. As seen…

    • 3340 Words
    • 11 Pages
    Good Essays
  • Powerful Essays

    Levy MD. ;A new register for clinical trials information. Can Med Assoc J. 2000; 162-970-971.…

    • 3895 Words
    • 16 Pages
    Powerful Essays
  • Powerful Essays

    Alcohol Health

    • 3179 Words
    • 8 Pages

    References: Atherton, P., Jasperson, B., Nibbe, A., Clement-Brown, K., Allmer, C., Novotny, P., Erlichman, C. and Sloan, J. (2003). What Happened to All the Patients? Event Charts for Summarizing Individual Patient Data and Displaying Clinically Significant Changes in Quality of Life Data. Therapeutic Innovation & Regulatory Science, 37(1), pp.11-21.…

    • 3179 Words
    • 8 Pages
    Powerful Essays
  • Good Essays

    Home Care Intervention

    • 636 Words
    • 3 Pages

    to interventions. It also evaluated the progress the patient made toward the short of long term goal.…

    • 636 Words
    • 3 Pages
    Good Essays
  • Powerful Essays

    Care Plan

    • 495 Words
    • 3 Pages

    Goals: Now is the time set patient centered goals. Here you will develop expected outcomes using the seven…

    • 495 Words
    • 3 Pages
    Powerful Essays
  • Satisfactory Essays

    Health Belief Model

    • 343 Words
    • 2 Pages

    Client Outcome/Goal: patient demonstrates and verbalizes the ability to cope, patient sets and achieves goal made, patient able to maintain goals regarding diet and exercise…

    • 343 Words
    • 2 Pages
    Satisfactory Essays
  • Good Essays

    The Leading Distributor of Market Research Reports, marketoptimizer.org publishes report on “Addison’s Disease (Primary or Chronic Adrenal Insufficiency) Global Clinical Trials Review, H1, 2014”.…

    • 623 Words
    • 3 Pages
    Good Essays
  • Good Essays

    The final stage is known as termination stage, is defined as a person who has achieved success in their change. In this stage, it shows that the person has made the change and kept the change consistently for 6 months. For example, an overweight person who has seen the need to change and has made a physical change for a consistent 6 months. That person would be seeing many changes and would be considered free from relapse.…

    • 640 Words
    • 3 Pages
    Good Essays