Advisor 465

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

u page 6 statements – one for healthcare professionals and one for the general public – to give assurance that the regulatory processes for the authorisation and safety monitoring of vaccines are robust, independent and focus firmly on public health. In recent years, vaccination coverage has dropped to sometimes dangerously low levels in some countries, which increases the risk of the disease spreading and afecting the unvaccinated. The ICMRA statements reiterate that it is everyone’s responsibility to get vaccinated in order to protect not only themselves but also their friends, communities, vulnerable populations who cannot get immunised and generations to come. The statement aimed at the general public highlights the value of vaccines in the context of the current pandemic and addresses a range of topics,

including the following: • vaccines save lives • getting vaccinated is an act of responsibility • vaccines undergo rigorous scientific evaluation by regulatory authorities • vaccines have continuously proven pharmaceutical quality • assuring vaccine safety is an extremely important part of their regulation • each vaccine lot is individually tested by the national control laboratory • regulators and health authorities continue to rigorously monitor the safety, efectiveness and quality of vaccines that have been approved and released for use. Source: , ,

FDA provides guidance on statistical considerations for COVID-19 trial modifications As part of its ongoing efforts to limit the impact of the COVID-19 pandemic on clinical trial conduct, the FDA has issued new guidance entitled ‘Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency’.

The short guidance document (issued on 16 June 2020) acknowledges the significant impact of the COVID-19 pandemic on the way in which trials have been performed. The need for social distancing, travel restrictions and site closures, etc, have meant that some studies have been halted or discontinued, while others have been able to continue after implementing modifications made possible by recent regulatory changes. The FDA is conscious that there will be an inevitable delay in certain potential new medications reaching the market. The new guidance therefore outlines considerations for the statistical analysis of primary and key secondary endpoints in a trial afected by COVID-19, to help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty.

The policy is only intended to remain in efect for the duration of the COVID-19 public health emergency. Trial integrity To ensure trial integrity, the guidance outlines three requirements when considering trial modifications in response to COVID-19. • Plan for participant safety . Sponsors should proactively plan to address the impact of COVID-19 on the ability to meet the trial objectives. Modifications to the primary or key secondary endpoints would usually require a protocol amendment, and any changes should be reflected in an updated statistical analysis plan before the database is locked and before any modifications to unblinded interim analyses. page 9 u

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Issue 465, 2020

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