Patient registries can be heterogeneous in their quality and design, however a new study in Drug Safety co-authored by a European Medicines Agency (EMA) official outlines how patient registries may provide valuable data for regulatory decisions. Such registries may be used when randomised controlled trials are not feasible, for example with some rare diseases, or to meet post-marketing commitments. Read more “EMA study outlines how patient registries may prove valuable in regulatory decisions”
Category: Trials
FDA asks for comments on ICH guideline on optimising safety data collection
The United States (US) Food and Drug Administration (FDA) have asked for comments on a guideline from the International Council for Harmonisation (ICH) on how to collect safety data in certain late-stage pre-approval or post-approval studies when the safety profile of a drug is sufficiently characterised. Read more “FDA asks for comments on ICH guideline on optimising safety data collection”
European regulators encourage all sponsors to publish clinical trial results in European Union database
The European Medicines Agency (EMA), European Commission (EC) and the Heads of Medicines Agencies (HMA) have sent a letter to clinical trial sponsors reminding them of the requirement to publish the results of all clinical trials conducted in the European Union (EU) in the EudraCT database. Read more “European regulators encourage all sponsors to publish clinical trial results in European Union database”
Health Canada outlines when off-label use is not considered investigational in a clinical trial
Health Canada have issued a notice which outlines the circumstances in which the off-label use of an authorised drug in a clinical trial would not be considered investigational. The notice went into effect on 5th June 2019, and Health Canada have stated that the notice will “serve as interim interpretive guidance until amendments can be made to the Food and Drug Regulations.” Read more “Health Canada outlines when off-label use is not considered investigational in a clinical trial”
UK clinical trial pilot helps companies prepare for the new EU Clinical Trial Regulation
To prepare for the future of clinical trials under the European Union (EU) Clinical Trial Regulation 536/2014, the United Kingdom (UK) has been running a pilot program which aims to streamline the submission and review process for applications to run Clinical Trials of Investigational Medicinal Products (CTIMPs). Read more “UK clinical trial pilot helps companies prepare for the new EU Clinical Trial Regulation”
ICH opens public consultation on their drafted revised guideline E8(R1) on the general considerations for clinical trials
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”
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”