Advisor 462

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

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Table 1 . Findings by inspection type (1 April 2018 – 31 March 2019).

Number of inspection findings a

Number of inspections

Critical

Major

Minor

Total

Inspection type

Routine initial inspection Routine re-inspection Previous critical finding

9 7 2

0 3 1

41 31 6

23 12 3

64 46 10

Total (average/inspection)

18

4 (0.22)

78 (4.33)

38 (2.11)

120 (6.67)

a Numbers estimated from bar charts in the report. period, while the average number of major findings per inspection has increased from a low of two in the reporting period January 2009 – March 2010 to just over four in the most recent period. The average number of minor findings reported per inspection

has also fluctuated over time. However, there has been an overall decrease from approximately 3.8 in the 12-month period to December 2006 to 2.1 in the most recent period. Source:

EC issues guidance to mitigate EU clinical trial disruption during the pandemic

The European Commission (EC) has published Version 3 of its guidance on managing clinical trials during the COVID-19 pandemic.

The aim of the guidance (released on 28 April 2020) is to mitigate the disruption of clinical research in Europe and avoid further negative effects of the pandemic, without compromising on quality and safety. The recommendations are an important part of the overall strategy for finding treatments and a vaccine to protect citizens against coronavirus. The original guidance was published on 20 March 2020 by the Clinical Trials Expert Group, supported by the European Medicines Agency (EMA), the Clinical Trials Facilitation and Coordination Group of the Heads of Medicines Agencies, and the EMA’s GCP Inspectors’ Working Group. Version 2 followed on 27 March 2020. With more than 200 coronavirus clinical trials now registered on the EU’s EudraCT database, the guidance offers recommendations for simple and flexible measures to respond to the current situation, and to ensure that patients participating in clinical trials across the EU can continue to receive their medicines.

Commissioner Stella Kyriakides said, “We are in the midst of the worst pandemic in recent memory and it is absolutely crucial that we show flexibility in our rules to maintain research on critical treatments, including chronic and rare diseases, through clinical trials. Developing and deploying effective diagnostics, treatments and a vaccine will also undoubtedly be the most important breakthrough to stop the coronavirus. On 4 May, our international pledging conference will kick-start global cooperation and support for this work, with the aim to raise €7.5 billion in funding to the benefit of the global community. Together in solidarity, we will prevail.” Key recommendations in the 21-page guidance document include the following. • Distribution of medicines to patients in clinical trials: the purpose is to protect the safety and well-being of trial participants and the integrity of clinical trials. The recommendation takes into account social distancing measures

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