• Regulatory NewsRegulatory News

    FDA threatens drugmaker with fines for failing to report trial results

    Acceleron Pharma became the first drugmaker to face potential fines from the US Food and Drug Administration (FDA) for failing to report clinical trial results to ClinicalTrials.gov.   In a notice of noncompliance sent to Acceleron on 27 April, FDA notified the Cambridge, MA-based drugmaker that it has 30 days to correct the issue or face up to $10,000 per day in civil monetary penalties or other regulatory action including injunction or criminal prosecution.   Mat...
  • Regulatory NewsRegulatory News

    Older adults, Black patients underrepresented in post-marketing studies

    In postmarketing studies of cancer therapies approved by the US Food and Drug Administration (FDA), representation of older adults and Black patients does not appear to be improved compared with premarketing studies, a recent investigation in JAMA Network Open suggests.   In addition, the sex and race of participants were identified less frequently in postmarketing studies than premarketing studies, according to a cross-sectional analysis of 77 premarketing and 56 po...
  • 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...
  • Regulatory NewsRegulatory News

    ICH shares "work-in-progress" update to GCP guidance

    The International Conference on Harmonization (ICH) has made available a draft version of its updated principles for good clinical practice. The principles are to be considered a “work-in-progress,” wrote ICH in announcing the availability of the updates, which are still in development by the ICH’s E6(R3) expert working group.   “The principles are interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliabl...
  • Regulatory NewsRegulatory News

    FDA: Master protocols have value in COVID-19, and beyond

    An official from the US Food and Drug Administration (FDA) recommended that developers of COVID-19 drugs consider using master protocols to assess the benefits and the risks of potential COVID-19 treatments and outlined ways to ensure the integrity of the data generated from these protocols.   Gregory Levin, the deputy director of the Division of Biometrics III in the FDA’s Office of Biostatistics, described how master protocols can be leveraged to evaluate the safety ...
  • Regulatory NewsRegulatory News

    Woodcock: Post-COVID, new flexibility could boost cancer trial diversity

    Though cancer clinical trials have taken a hard knock from COVID-19, preserving and extending pandemic flexibility may give oncology research broader reach than ever before, according to Janet Woodcock, MD, the acting commissioner of the US Food and Drug Administration (FDA). Woodcock spoke Friday at a webinar co-hosted by Friends of Cancer Research and the American Society of Clinical Oncology,   At the meeting, whose focus was how to improve patient access and repres...
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    Clinical trial diversity: FDA pushes real-world evidence, diffusion of trial sites

    Real-world evidence, post-marketing studies, and migrating clinical trial sites into underserved communities are all strategies the U.S. Food and Drug Administration (FDA) is pushing to help increase data on the outcomes of minority patients, according to Amy Abernethy, MD, PhD, the agency’s principal deputy commissioner.   “There is real a gap between the makeup of our American public and the representation of our Black community and Black women in clinical trials,” A...
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    Can older adult clinical trial participation be boosted?

    The US Food and Drug Administration on Tuesday convened leaders from the agency, industry and academia to tackle barriers and solutions to enrolling older adults in clinical trials. Highlights of the virtual public workshop included solid data from FDA showing the mismatch between disease prevalence and age representation in clinical trials, as well as an in-depth examination of how older adults were represented in COVID-19 vaccine trials.   S. W. Johnny Lau, PhD, a ...
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    Shuren and Stenzel: Bending the arc of testing for COVID – and beyond

    The U.S. Food and Drug Administration’s efforts to rapidly authorize point-of-care and at-home tests during the COVID-19 pandemic could offer a roadmap for a broad effort to bring diagnostic and screening tests to homes and remote locations for a variety of diseases. “The development and authorization of COVID-19 [point-of-care] and at-home tests has been remarkable; a process that can often take more than a year took only a few months in many cases. We believe that les...
  • 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

    Strategies for clinical development planning

    Clinical development planning can be thought of as the integrated design and structuring of the steps from the first phase 1 study for the initial assessment of safety, to one or more phase 2 studies for better understanding the product’s pharmacology, safety, and effectiveness, to a phase 3 definitive demonstration of efficacy and safety. Optimal strategy can be informed by creating a vision for the product in the form of a target product profile, examining precedence (wh...
  • RF Quarterly

    Clinical trials, good clinical practice, regulations, and compliance

    This article provides an overview of the international and national guidelines associated with clinical trials. The authors highlight the importance of multiregional clinical trials and outline the principles of good clinical practice (GCP) and regulatory compliance.   Introduction Clinical trials are essential components of pharmaceutical research and development. A clinical development program’s broad aim is to treat a specific indication in a certain population to...