All Clinical Trials articles
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JournalLatin America: From low-cost venue to strategic platform in veterinary clinical research
This article disucsses Latin America’s strategic capacity to support global dossiers for the registration of veterinary medicines, through its growing range of research programmes, from antiparasitics and vaccines for production animals to advanced treatments for companion animals
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ContentsRegulatory Rapporteur October 2026 – Contents
The October issue of Regulatory Rapporteur focuses on clinical trial design and real-world evidence.
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JournalCOMBINE EU pilots: Roche’s experience as first pilot participants
Drawing on two successfully approved COMBINE pilot combined studies, this article shares practical experience of coordinated submissions and assessments, highlighting the benefits, operational challenges and potential solutions for making cross-regulation studies more efficient.
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JournalMultistakeholder collaboration to translate the ICH GCP E6(R3) guideline into Finnish: Supporting clinical trial conduct in Finland
This article summarises the process and outcomes of the ICH GCP E6(R3) translation and terminology project, an example of multistakeholder collaboration to advance a shared understanding of a well-established international guideline in a national context
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JournalClinical trial diversity and regulatory decision-making: Implications for dosing, safety and global alignment
Through selected case studies, this article explores how evidence gaps related to sex, ethnicity and representative trial populations have shaped regulatory outcomes across different therapeutic areas and discusses strategies for more robust evidence generation.
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JournalThe evolving regulatory framework for clinical data management in the era of decentralised trials
This article examines the development of global regulatory expectations for clinical data management within decentralised clinical trials. It reviews strategies that CDM professionals are using and assesses current regulatory barriers and harmonisation gaps.
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JournalLean writing and disclosure-ready principles for clinical trial design and documents
A disclosure-ready principle is most effective within clinical trial design from the start. This article offers a three-step lifecycle structure to embed disclosure readiness into an embedded authoring and review discipline and avoid downstream challenges.
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JournalNavigating the Australian Office of the Gene Technology Regulator: A regulatory affairs perspective on clinical trials involving genetically modified organisms
This article provides a background to the OGTR’s role in overseeing the use of GMOs in clinical trials, the licence application process, different types of licences and conditions associated with each.
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Industry newsFDA finalises guidance aimed at widening access to cancer clinical trials
The US Food and Drug Administration (FDA) has finalised two guidance documents designed to help sponsors, Institutional Review Boards (IRBs) and investigators stop unnecessarily excluding cancer patients from clinical trials.
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Industry newsEU roadmap sets out 22 actions to phase out animal testing in chemical safety assessment
The European Commission has released a long-awaited roadmap towards phasing out animal testing for chemical safety assessments, having pledged to develop such an initiative in response to the European citizen’s initiative titled ‘Save Cruelty-Free Cosmetics – Commit to a Europe Without Animal Testing’, which was submitted to the ...
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Industry newsNew MHRA framework sets out IMA pathway for rare disease therapies
The MHRA has revealed its draft rare disease framework, open for consultation until 30 July. The current development model does not always suit the conditions for rare diseases as they require greater flexibility in how they are evaluated. The framework emphasises earlier engagement with regulators, flexible evidence requirements, ...
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Industry newsFDA launches Operation TrialBlazer to accelerate US clinical research
The US Food and Drug Administration (FDA) has announced plans to revitalise clinical research in the USA, as part of a US Department of Health and Human Services (HHS) initiative titled ‘Operation TrialBlazer’. The FDA has proposed multiple actions to achieve this aim, targeting both early- and late-stage ...
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ContentsRegulatory Rapporteur June 2026 – Contents
The June issue of Regulatory Rapporteur focuses on lifecycle management.
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JournalPlain language results in UK clinical trials: Navigating new regulatory requirements and practical challenges
This analysis examines the new regulatory requirements for providing plain language summaries of trial results to participants, outlines operational challenges and offers practical recommendations for compliance with the HRA’s transparency framework.
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Industry newsACT EU issues draft guidance on clinical trials during emergencies
Accelerating Clinical Trials in the EU (ACT EU) has issued new draft guidance that outlines clinical trial conduct during public health emergencies (PHEs). Public consultation is open until 30 April 2026.
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JournalWMA declarations: Helsinki in the spotlight and Taipei in the background
This article examines the role of the Declarations of Helsinki and Taipei in the ethical oversight of research and data and calls for a unified governance framework that integrates participant protection across the entire research lifecycle.
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JournalNavigating regulatory scrutiny: An analysis of requests for information in EU combined clinical trials
This article explores aspects of IVDR and how to implement these during clinical trial processes including submissions.
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JournalParenteral drug delivery systems: Driving clinical success
This article examines the key challenges and best practices in developing parenteral drug delivery systems that pair drugs with specialised devices.
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Industry newsMHRA cuts approval times for UK clinical trials in half
This industry news update announces the MHRA’s decision to reduce clinical trial approvals from 91 days to 41 days.
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JournalNavigating the landscape of paediatric clinical trials under US FDA guidelines
This article explores paediatric clinical trials under the guidelines of US Food and Drug Administration (FDA) legislation, focusing on research development and ethics.