News from the World of Clinical Research

Recent News

    MHRA Survey

    By ICR Secretariat / 9/19/2017 10:47:44 AM

    The Medicines and Healthcare products Regulatory Agency is conducting a survey to better understand how it can support its customers.

    'As part of our continued commitment to deliver a high-quality se…

    APM Women in Project Management Event

    By ICR Secretariat / 9/11/2017 1:03:28 PM

    Are you a Progressive Project Professional?
     
    Hear from innovative thinkers and industry leaders as well as network with other senior professionals from different industries at the APM National Conf…

    EMA Annual Report of the GCP IWG 2016

    By ICR Secretariat / 9/6/2017 1:58:37 PM

    The EMA has released the 2016 Annual Report of the Good Clinical Practice Inspectors Working Group.

    The GCP IWG focuses on harmonisation and coordination of GCP related activities at EU level. 

    The…


    PIPMG - Smart Project Management Event

    By ICR Secretariat / 8/10/2017 11:07:49 AM

    Projects are typically focused on deliverables at the end and we can focus single-mindedly on these. This meeting will look at how you can optimise your work to gain tangible benefits for your busines…

    GCP inspection metrics for 2015 to 2016 published

    By ICR Secretariat / 7/24/2017 11:47:55 AM

    Last week the MHRA published the 1st April 2015 to 31st March 2016 GCP Inspection metrics report.


    During the metrics period a total of 102 GCP Inspections were undertaken by the MHRA GCP Inspectorate…

    Statistical analysis outlines level of data fabrication in some clinical trials

    By ICR Secretariat / 6/22/2017 3:22:20 PM

    A statistical analysis of just over 5,000 randomised, controlled trials published in anaesthetic and general medical journals has found suspicious statistical patterns in some, raising concerns over t…


    Action needed to prevent confusion over medicines

    By ICR Secretariat / 6/22/2017 3:15:40 PM

    Only about a third (37%) of the public trust evidence from medical research, compared to approximately two-thirds (65%) who trust the experiences of their friends and family*, according to a report la…

    HRA Update - Single form to REC and R&D Submissions from next week

    By ICR Secretariat / 6/22/2017 10:41:39 AM

    From the evening of 28 June 2017, a combined IRAS form that merges the Research Ethics Committee (REC) and R&D forms will be used across the UK. Already in place for projects where the lead NHS R&…

    FDA Planning Phased Transition to New Cures Act Drug Development Tool Qualification Scheme

    By ICR Secretariat / 6/20/2017 1:39:22 PM

    The FDA is planning to transition to a new drug development tool qualification process — as required by the 21st Century Cures Act — for clearing the use of biomarkers, clinical outcomes assessments a…


    Governments Must Commit Funding for Data Sharing to Flourish

    By ICR Secretariat / 6/20/2017 1:17:59 PM

    Data sharing is widely agreed to be beneficial for both scientists and the general public, but hosting data is expensive, and government agencies rarely have the funds to build and support such platfo…

    Merck pauses cancer studies due to patient deaths

    By ICR Secretariat / 6/20/2017 1:06:23 PM

    Mercks has paused enrollment in two studies for their immunotherapy drug, Keytruda after an external Data Monitoring Committee reccomendation. The Committee has recommended the move to gain more infor…

    Quintiles joins NHS Vanguard's Real World Data Initiative

    By ICR Secretariat / 6/20/2017 11:45:19 AM

    QuintilesIMS has entered into a strategic collaboration with the national Cancer Vanguard to contribute its anonymised patient level, real world data on drug usage treatment costs and outcomes to exte…


    Gene therapy by the numbers

    By ICR Secretariat / 6/19/2017 3:39:17 PM

    Gene therapies have been in clinical development for decades, a winding, stop-and-start path toward transforming science's understanding of the genome into commercial therapies. 

    Biotechs like Spark …

    ICH Expands MedDRA's Uptake Globally

    By ICR Secretariat / 6/19/2017 3:33:14 PM

    This week The International Council for Harmonization (ICH) touted the global expansion of its Medical Dictionary for Regulatory Activities (MedDRA). MedDRA, which was initially developed to provide s…

    Aberdeen University to launch investigation after report uncovers clinical trial failures

    By ICR Secretariat / 6/7/2017 2:16:33 PM

    ABERDEEN University has launched a probe following claims it failed to follow international ethical guidelines in its clinical trials. External researchers found failures including failing to register…


    Dozens of recent clinical trials contain false data

    By ICR Secretariat / 6/7/2017 1:24:10 PM

    Dozens of clinical trial reports likely contain inaccurate data. The information comes from John Carlisle, who used statistical tests to determine where sampling may have not been random. Essentially,…

    China is about to begin clinical trials on embryonic stem cells

    By ICR Secretariat / 6/6/2017 3:39:58 PM

    Surgeons in Zhengzhou, China, will soon begin the first clinical trial of embryonic stem cells on parkinsons sufferers, injecting the stem cells directly into the patients brains. The scientific commu…

    Delay in the development of the EU portal

    By ICR Secretariat / 6/5/2017 10:51:31 AM

    The EU portal, an integral part of the new EU Regulations 536/2014, has been delayed again. It is not yet clear whether this will delay the implementation date of the EU Regulation. More details will …


    EMA Publishes Brexit Guidance Section of Their Website

    By ICR Secretariat / 5/4/2017 10:22:38 AM

    The EMA have published guidance for marketing authorisation holders over how Brexit will affect their responsibilities. Particularly, they remind companies that marketing authorisation holders must be…