All Clinical Trials articles
-
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.
-
Industry newsMHRA seeks to cut approval time by 50% for ‘lowest-risk’ RCTs
The MHRA is set to introduce a new scheme which aims reduce the time taken by the agency to approve the lowest-risk clinical trials.
-
Industry newsBurkina Faso gives R21 malaria vaccine approval in children
Burkina Faso’s regulatory agency – Agence Nationale de la Regulation Pharmaceutique – has approved the R21/Matrix-M malaria vaccine for children.
-
JournalA year of clinical trials under IVDR:
a sponsor’s perspectiveThe new EU in vitro diagnostic medical devices regulation (IVDR) extends to medical use of in vitro diagnostics (IVDs) in clinical trials, in addition to marketed IVDs. Although compliance to some aspects has been required since the Date of Application on 26 May 2022, there has been ...
-
Industry newsAI-generated drug first to reach Phase II trials
Insilico Biotech’s INS018_055 – a drug generated by AI – is a treatment for a rare lung disease and the first AI drug to enter a Phase II trial.
-
Industry newsStakeholder feedback sought on EMA draft clinical guidelines
The EMA has published draft guidance − ICH E6 (R3) − on good clinical practice for clinical trials, which is open for public consultation.