All Clinical Trials articles
-
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.
-
JournalDiversity in clinical research: Regulatory considerations and updates
This article explores how to improve diversity and patient representation in clinical trials and looks at guidance from the EMA.
-
ContentsJuly/August 2025 – Contents
The July/August issue of Regulatory Rapporteur focuses on patient involvement.
-
EditorialPatient voice: Shaping the future of medicine regulation
This issue looks at the evolving landscape of public and patient involvement (PPI) and how the views of the patient community are being included in research, academia, health and social care and regulatory decision-making.
-
Industry newsFDA to replace animal testing with new approach methodologies
The US Food and Drug Administration (FDA) has announced plans to replace animal testing for monoclonal antibodies (MABs).
-
JournalRegulatory governance for medical research in the United Arab Emirates: A comprehensive overview
Since the country’s establishment in 1971, the United Arab Emirates (UAE) has strived for the continual progress and prosperity of the country and its people. This is reflected in the constantly improving research regulatory governance framework that encompasses both federal and local requirements. This article provides a comprehensive overview of the UAE’s research governance structure and highlights its requirements and applicable legislation, both at federal and local levels.
-
JournalClinical research in Africa: Regulatory environment, challenges and opportunities
Africa is a destination for clinical research and its developments and growing potential should not be overlooked. There are benefits for those who intend to gain an understanding of the challenges and opportunities on this large and varied continent. Although the diversity of the people, cultures and regulations in Africa has an impact on complexity, there are numerous regulatory and harmonising organisations working to improve efficiencies, many of which require meticulous collaboration.
-
Industry newsMHRA approves Nemolizumab for eczema patients in the UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Nemolizumab, also known as Nemluvio, to help with the treatment of atopic dermatitis (eczema) in the UK.
-
-
Industry newsFDA programme set to improve diversity in clinical trials
The US FDA’s Oncology Center of Excellence has launched an initiative to improve access to clinical trials for under-represented populations.
-
Industry newsMelanoma vaccine enters Phase III clinical trials
A personalised mRNA vaccine for a deadly form of skin cancer is being rolled out in an international Phase III clinical trial.
-
Industry newsParkinson’s drug slows progression of motor symptoms
A developmental drug has shown promise in slowing symptoms of motor deterioration in people with advanced forms of Parkinson’s.
-
JournalClinical trial design – keeping up with innovation
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Abstract A well-designed clinical trial is essential for the collection of reliable, robust and meaningful data to ensure the protection of participants rights and safety and also minimise economic losses ...
-
Industry newsAngioedemas caused by rare gene fault curable by CRISPR
A single dose of a CRISPR gene therapy has been shown to almost eliminate a rare genetic, inflammatory and potentially life-threatening condition.
-
Industry news3D-printed device could reduce need for animal testing
A 3D-printed device is able to determine the effects of drugs on the human body and could help reduce the need for testing drugs in animals.
-
JournalPS2: ATMP innovations and clinical trials with genetically modified organisms
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Jayne Hunt, Principal Regulatory Affairs Consultant, Ariello. Speakers: Patrick Ginty, Boyds Consultants. Isabel Borba Vieira, Nonclinical Assessor at Medicines Evaluation Department Scientific Evaluation Unit, ...
-
Industry newsJ&J to submit trial application for surgical robot
Johnson & Johnson’s MedTech division is set to submit its robotic surgical system to the FDA in order to initiate clinical trials.
-
VideoICMRA regulators to mark its 10th year at event in Australia
International Coalition of Medicines Regulatory Authorities set to celebrate 10 years of strategic leadership at Melbourne summit.
-
JournalHM4: The evolving clinical trial landscape
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Carlos Alves - Vice President, Infarmed, Portugal Speakers: Olga Kholmanskikh, Clinical Assessor, Federal Agency for Medicines and Health Products (FAHMP), Belgium. Björn Eriksson, Director ...
-
JournalA harmonised approach to clinical data standards
David Evans, President and CEO of Clinical Data Interchange Standards Consortium (CDISC), speaks to the journal’s November Issue Editor Leah Kleylein to discuss his role at the helm of the standards development organisation and the ways it is advancing global data standards in the clinical research realm.