• RF Quarterly

    The history of clinical trial disclosure

    The scope and complexity of requirements for global clinical trial disclosures and data sharing have increased substantially over the last 20 years. Most leading countries have specific regulations pertaining to trial conduct, and many have set up patient registries for collecting and analyzing data on patient outcomes. More recently, authorities have initiated inspections relating to disclosure to ensure compliance with regulations, and transparency advocates continue to ...
  • Regulatory NewsRegulatory News

    Clinical trial diversity: Sponsors seek clarity on data sources, timing

    Drugmakers and clinician organizations praised the US Food and Drug Administration’s (FDA) recent draft guidance containing recommendations on developing a Race and Ethnicity Diversity Plan to improve enrollment of underrepresented racial and ethnic groups in clinical trials. But in public comments, they also called for greater details on the types of data that should be used to assess adequate enrollment of these populations, how these diversity plans should be applied to...
  • Regulatory NewsRegulatory News

    Former FDA officials call for more transparency for drug approvals

    The US Food and Drug Administration (FDA) needs to take a more proactive approach in combatting misinformation and communicating decisions to the public when approving drugs, especially when the decision goes against the recommendations of its advisory committees. Not doing so will continue to undermine the public’s trust in the agency, said a panel of former FDA commissioners and others at the Food and Drug Law Institute (FDLI) annual conference on Tuesday.   Califf ad...
  • Feature ArticlesFeature Articles

    Considerations for selecting control groups in pediatric clinical trials

    ICH E10 provides specific guidance on the choice of control groups for clinical trials, but there are additional considerations for choosing a control group for a pediatric trial. In this article, the author looks at different types of control groups and the specific challenges that present when considering the design for a pediatric trial, such as the medical condition being treated, the potential patient population, suitability of comparators, and availability of real-wo...
  • Regulatory NewsRegulatory News

    Digital health tech in clinical investigations: FDA issues draft guidance

    The US Food and Drug Administration, as part of an end-of-year spate of guidance documents, has issued a draft guidance for sponsors who wish to use digital tech to aid in remote clinical data acquisition.   Digital health technologies (DHTs) stand to benefit clinical investigations in a multitude of ways, but regulatory considerations have to be weighed as the technologies are employed, noted the agency in setting out the background for the draft guidance, issued in l...
  • Regulatory NewsRegulatory News

    Study: RWD not ready for postapproval prime time

    For drugs and biologics that receive accelerated approval, could information drawn from real-world data sources supplant traditional postapproval clinical trials to confirm that the therapies have benefit? Real-world data (RWD) are not yet robust enough to confirm the benefit of drugs awarded accelerated approval based on surrogate endpoints, answered the authors of a recent study.   “The findings of this cross-sectional study suggest that none of the 50 [Food and Drug...
  • Regulatory NewsRegulatory News

    Improving transparency of regulatory data at EMA, Health Canada, FDA

    Over the last decade, the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Health Canada (HC) have gotten better at disclosing previously confidential clinical data, a study published in The Journal of Law, Medicine & Ethics has found.     However, each agency discloses this data in a variety of different ways, according to Alexander C. Egilman, with the Center for Outcomes Research and Evaluation at Yale–New Haven Hospital in New Haven, CT,...
  • Feature ArticlesFeature Articles

    China’s data localization‒centric policies and their impact on human research

    This article reviews Chinese laws governing healthcare data and genomic resources during 1998-2021 and their impact on clinical research in humans by pharmaceutical companies. Companies conducting such research must be vigilant about complying with the complex legal requirements governing the research and identifying potential risks and mitigation strategies for compliance. The analysis includes review of various legal requirements issued by the People’s Republic of China ...
  • Regulatory NewsRegulatory News

    EU clinical trial portal and database declared functional

    The European Medicines Agency (EMA) announced that its long-delayed EU clinical trial portal and database are fully functional, paving the way for the launch of the EU Clinical Trial Information System (CTIS) and the application of the EU Clinical Trial Regulation early next year.   The CTIS was originally expected in September 2018; however, a series of delays have pushed back the launch date for the system, and the EU Clinical Trial Regulation it is intended to suppo...
  • RF Quarterly

    RF Quarterly, March 2021: Global clinical trials

    Welcome to the inaugural issue of RF Quarterly featuring original, thematically developed content by regulatory experts addressing key areas and emerging issues in the global regulatory landscape. RF Quarterly is a member-exclusive addition to the regular monthly  Regulatory Focus  feature articles and replaces the former quarterly article series. The theme for this issue is Global Clinical Trials.   Clinical trials are an essential component of pharmaceutical re...
  • RF Quarterly

    Planning for a clinical trial application

    In recent years, global clinical trials have become standard, and for a good reason. In broad terms, expanding clinical trials across the world provides a better opportunity for demonstrating the true impact of an investigational drug. Global clinical trials offer key advantages to patients and industry, but smaller companies may be hesitant to participate in global trials, wondering if the inevitable challenges outweigh the benefits. The key considerations in designing a ...
  • RF Quarterly

    Modernizing clinical trial regulations in Canada

    This article provides an overview of Health Canada’s plans to modernize its clinical trials regulations and enhance health care agility in the regulatory framework for its health care products by making regulations more flexible and adaptive to innovation. The author discusses how clinical trials in several health care product lines can be modernized and looks at how lessons learned from the COVID-19 pandemic experience can help set up a more flexible regulatory framework ...