Advisor 462

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

STOP PRESS – global news

EMA starts rolling review of a potential COVID-19 treatment The European Medicines Agency (EMA) has begun a ‘rolling review’ of data on the use of the investigational antiviral medicine remdesivir for the treatment of coronavirus disease (COVID-19). The decision by the Committee for Medicinal Products for Human Use (CHMP) to start the rolling review was based on preliminary study results that suggest a beneficial effect in hospitalised patients with mild-to-moderate or severe COVID-19. Announcing the decision on 30 April 2020, the EMA explained that a rolling review is a regulatory tool that can be used to speed up the assessment of a promising investigational medicine during a public health emergency, such as the ongoing pandemic. Commencing a rolling review does not imply that a drug’s benefits outweigh its risks. In a rolling review, CHMP Rapporteurs are appointed while development is ongoing, and data are reviewed as they become available. Several rolling review cycles can be performed during the drug’s evaluation as data emerge, with each cycle lasting around 2 weeks. Once the data package is complete, the developer can submit a formal marketing authorisation application, which is then processed under a shortened timetable. While the overall review timeline for remdesivir is currently unknown, the EMA should be able to complete its assessment significantly more quickly than usual, while still ensuring that German guidance on clinical trials during the pandemic Although the German Federal Institute for Drugs and Medical Devices (BfArM) participated in compiling the European Commission’s guidance (Version 3.0) on the management of clinical trials during the current pandemic, BfArM has also issued supplementary local guidance entitled ‘Supplementary Recommendations to the Document European Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic ’. Within its supplementary guidance (issued on 26 March 2020), BfArM highlights the need to consider specific national laws and guidelines in individual Member States on key clinical trial topics, which may take precedence over European recommendations. The guidance specifically addresses remote data monitoring and the shipment of investigational medicinal product to trial subjects. Source: a robust scientific opinion is reached. Source:

Changing face of FDA drug approvals

A study published in JAMA Network Open on 21 April 2020 evaluates whether the number and characteristics of pivotal efficacy trials supporting the US approval of new drugs and biological products have changed over the past 3 decades. Looking at 273 new drugs and biological products approved by the FDA for 339 indications in three periods (1995–1997, 2005–2007 and 2015–2017), the study found that more recent approvals increasingly used special regulatory programmes and were based on fewer pivotal trials than older approvals. When aggregated by indication, these trials had less rigorous designs but longer durations. The US authors suggest that ongoing post-approval evaluation of therapeutic safety and efficacy is needed. Source: Communicating results of COVID-19 trials On 4 May 2020, the Editors of JAMA highlighted concerns about the reporting of results from COVID-19 clinical trials. At the time of writing, more than 600 interventional studies and randomised clinical trials relating to COVID-19 were registered on ClinicalTrials.gov, with data likely to become available in the coming weeks and months. Presenting and interpreting these results clearly – and communicating findings appropriately to clinicians, the public and policy makers – are critically important. Investigators, journals and the media have an obligation to report the results, and what they mean for individuals and population health, accurately and responsibly. Source: New FDA guidance on non-binding feedback after device inspections On 21 April 2020, the FDA issued final guidance on non-binding feedback after certain FDA inspections of device establishments. The guidance explains how a device establishment may submit a request for non-binding feedback about the corrective actions it proposes to take to address certain inspectional observations documented by the agency during an inspection. The guidance identifies a standardised communication method, and describes how the FDA

evaluates and responds to requests. Source:

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