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  • Feature ArticlesFeature Articles

    Electronic platforms for submission of clinical trial information

    This article provides guidance for use of the European electronic platforms for retrieving and submitting information about clinical trials and compares them with other similar regional electronic databases, such as the US Food and Drug Administration’s MyStudies mobile app and Switzerland’s national platform, swissethics. The authors present an overview of some of the main international portals, available and under development, and provide an analysis of their specific as...
  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: EMA shares advice on validated computer systems used in clinical trials

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA shares advice on validated computerized systems used in clinical trials   The European Medicines Agency (EMA) has published a notice about validating and qualifying all types of computerized systems used in clinical trials. EMA released the notice in response to “recent inspection findings” and their implications for the “integrity, reliability, robustness and accep...
  • Regulatory NewsRegulatory News

    RWE to Supplement RCTs: FDA Projects Continue

    The US Food and Drug Administration (FDA) has been working with several different data and research companies to further its understanding of how real-world data (RWD) and real-world evidence (RWE) can help to inform its regulatory decision making. One such company that has signed an RWE research collaboration with FDA is COTA, Inc., which is working on a project related to replicating a breast cancer study. Andrew Norden, chief medical officer of COTA, told Focus ...
  • Regulatory NewsRegulatory News

    EC Offers New Site Suitability Template Under Incoming Clinical Trial Regulation

    The European Commission (EC) on Tuesday published a new site suitability template that sponsors of clinical trials can use as part of the application dossier under the EU’s new clinical trial regulation, which has yet to take effect. The template was developed and endorsed by the EU Clinical Trials Expert Group on 9 October to comply with the new regulation, known as Regulation (EU) No. 536/2014 Clinical Trials on Medicinal Products for Human Use. “However, this templat...
  • Regulatory NewsRegulatory News

    Patient Engagement in Device Trials: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Monday released new draft guidance explaining how sponsors can improve the design and conduct of medical device clinical investigations by using patient experience, perspectives and other relevant information. The 10-page draft mainly addresses four questions: What approaches might sponsors use to engage patient advisors (defined by FDA as those who have dealt with or are dealing with a particular condition but are not inv...
  • Regulatory NewsRegulatory News

    Health Canada’s Public Release of Drug, Device Clinical Data Picks Up Steam

    Last March, amendments to Canada’s  Food and Drug Regulations and the Medical Devices Regulations enabled the public release of clinical information submitted to Health Canada for new drug and device approvals. But in the first five months after the amendments took effect, just one clinical trial package for a new drug and one clinical trial package for a new device were published. In the last two months, however, Health Canada has published information on eight more d...
  • Regulatory NewsRegulatory News

    Survey From CDRH Officials Finds Informed Consent Process Needs Improving

    Informed consent forms (ICFs) may meet the necessary regulatory requirements but are often not written in a way to promote comprehension among clinical trial participants, a new research article from six officials in the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) found. The officials surveyed 399 ICFs from investigational device exemption (IDE) applications for fiscal years 2015 and 2016, finding that overall, the ICFs were...
  • Regulatory NewsRegulatory News

    ICH Adds Four New Regulatory Observers

    Regulators from Argentina, Israel, Jordan and Saudi Arabia were recently approved by the International Council for Harmonisation (ICH) Assembly as Regulatory Observers. The approvals came at a meeting from 1-6 June in Amsterdam. ICH said the meeting was its largest biannual meeting ever and that progress was made on existing guidelines, training materials to support guideline implementation, the details of an ICH meeting in Silver Spring, MD, on 31 October on the revisi...
  • Regulatory NewsRegulatory News

    FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations

    The US Food and Drug Administration (FDA) on Thursday issued a draft guidance aimed at increasing diversity in clinical trial populations as part of its efforts to encourage drugmakers to enroll populations that more closely reflect the populations that will take the drugs in the real world.   “This guidance recommends approaches that sponsors of clinical trials to support a new drug application [NDA] or a biologics license application [BLA] can take to broaden eligibi...
  • Regulatory NewsRegulatory News

    EMA Officials Debate Going Beyond Safe and Effective Determinations for New Drugs

    In the US and Europe, drug regulators approve new drugs based on whether the benefits of the new product outweigh the risks. But neither of the regulators consider if such new drugs are superior to drugs currently marketed. Now, three senior officials at the European Medicines Agency (EMA) explain how an added therapeutic benefit criterion or head-to-head comparisons could help to drive more innovative therapies. “The aim of these proposals is to contain the rising c...
  • Regulatory NewsRegulatory News

    HMA Offers Recommendations on Complex Clinical Trials

    A subgroup of the EU’s Heads of Medicines Agencies (HMA) issued new recommendations Friday on conducting complex clinical trials.   The HMA’s Clinical Trials Facilitation Group (CTFG)—coordinated by the Danish Medicines Agency—identified eight key recommendations to establish a framework on the initiation and conduct of complex trials for the development of personalized medicine. They were prepared “in recognition of the fact that the development of personalized medici...
  • Regulatory NewsRegulatory News

    UK Seeks to Increase Clinical Trials Transparency

    The UK government issued a policy paper to improve clinical trials transparency in response to 10 recommendations a House of Commons Science and Technology committee report offered in 2018. “Research findings must be communicated in ways that are timely, meaningful and relevant to evidence users,” Parliamentary Under-Secretary of State for Health Baroness Blackwood said, welcoming the chance to address the October 2018 report . “Only with a system which values transpar...