The International Council for Harmonisation (ICH) have released a draft version of their guideline E8(R1) on the general considerations for clinical trials, which is open for public consultation. Read more “ICH opens public consultation on their drafted revised guideline E8(R1) on the general considerations for clinical trials”
Category: Trials
European Commission outlines the data protection requirements of the incoming Clinical Trials Regulation and how it interacts with GDPR
The European Commission have released a document which outlines the interplay between the clinical trial rules and the General Data Protection Regulation (GDPR). The guidance describes the data protection requirements of the new incoming Clinical Trials Regulation (CTR) and how the regulation relates to GDPR. The question and answer (Q&A) document will only be relevant when the CTR is implemented, however question 11 details the current situation under the Clinical Trials Directive. Read more “European Commission outlines the data protection requirements of the incoming Clinical Trials Regulation and how it interacts with GDPR”
MHRA releases guidance on how to manage safety reporting in a blinded trial
The Medicines and Healthcare Products Regulatory Agency (MHRA) have written a blog to clarify their expectations regarding the unblinding and reporting of serious adverse reactions (SARs) associated with comparator medicines. Read more “MHRA releases guidance on how to manage safety reporting in a blinded trial”
How to register clinical trials for investigational medicinal products and publish trial results if the UK leaves the EU with no-deal
The Medicines and Healthcare Products Regulatory Agency (MHRA) has released guidance about registering clinical trials, publishing trial results and future requirements if the United Kingdom (UK) leaves the European Union (EU) without a deal. The guidance will apply from exit day subject to the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019 being passed. The guidance will only apply in the event of ‘no-deal’ scenario. Read more “How to register clinical trials for investigational medicinal products and publish trial results if the UK leaves the EU with no-deal”
France to create clinical trial fast track for cell and gene therapies
France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) are to create a fast track for applications to run clinical trials of cell and gene therapies. The proposed regulatory process will reduce the time it takes sponsors to receive authorisation to start clinical trials to 110 days. Read more “France to create clinical trial fast track for cell and gene therapies”
FDA releases draft guidance on meta-analysis of randomised controlled clinical trials
The Food and Drug Administration (FDA) has released draft guidance on meta-analysis of randomised controlled clinical trials to evaluate the safety of human medicines or biological products. The FDA stated that conducting meta-analysis to evaluate safety questions presents a unique opportunity to detect and quantify the risk of a safety event and may help provide a more precise estimate of the risk of uncommon serious adverse events by combining information from multiple trials. Read more “FDA releases draft guidance on meta-analysis of randomised controlled clinical trials”
FDA releases draft guidance on master protocols – efficient clinical trial design strategies to expedite development of cancer drugs and biologics
The Food and Drug Administration (FDA) has released a 21-page draft guidance on master protocols, which aims to provide recommendations to sponsors of drugs or biologics for the treatment of cancer, regarding the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and paediatric cancers. Read more “FDA releases draft guidance on master protocols – efficient clinical trial design strategies to expedite development of cancer drugs and biologics”
MHRA updates GCP guidance to define inspection findings
In an update to the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) guidance on good clinical practices (GCPs), definitions for the inspection outcome terms “critical,” “major” and “other” have been provided. Read more “MHRA updates GCP guidance to define inspection findings”
MHRA clarifies post-Brexit Clinical Trials Regulation
The Medicines and Healthcare Products Regulatory Agency (MHRA) has provided clarification on how the United Kingdom’s (UK’s) clinical trial rules will function in partnership with the European Union (EU) after the UK leaves the EU in March 2019. Read more “MHRA clarifies post-Brexit Clinical Trials Regulation”
UK reassures industry that the aim is to adopt the EU Clinical Trial Regulation
The United Kingdom (UK) has committed to adopting the European Union (EU) Clinical Trial Regulation despite Brexit. In the House of Lords, a government representative has made a promise to prevent a potential rebellion that would have pushed for a legislative guarantee that the UK will adopt the regulation. Read more “UK reassures industry that the aim is to adopt the EU Clinical Trial Regulation”