Advisor 469

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

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u participants are kept informed of changes to the study and monitoring plans that could impact them”. The CTTI survey highlights the importance of communicating effectively with trial participants and acknowledges that patient organisations can assist in reviewing modifications, broader outreach and guidance. It is important to consider how participants view “safety” and their ability to participate in a trial in the context of the pandemic, as well as their concerns about a trial being paused or stopped. Participants’ needs change over time so these issues should be reassessed regularly. Ongoing risk–benefit assessment Participant and research personnel safety takes priority over data integrity concerns, so the aim should be to maintain safety while minimising the risks to trial integrity. The CTTI recommends a risk–benefit assessment for all studies. It outlines a three-tier system for making decisions on how to conduct ongoing and new research and directs readers to Question 1 in the Appendix of the ‘FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency’ (“What are some of the key factors that a sponsor should consider when deciding whether to suspend or continue an ongoing study or to initiate a new study during the COVID-19 public health emergency?”). Remote study visits Useful guidance is provided on how and when remote site visits may be performed, and the steps both participants and site personnel need to take to ensure that such visits are effective and compliant. The document also describes alternatives for planned safety assessments and the collection of endpoint data, when they cannot be conducted via telephone or video calls. Communication Institutional review boards (IRBs) can help sponsors and sites to ensure that their research remains ethical, valid and compliant, but the document notes that IRBs are currently receiving an unprecedented volume of changes to ongoing research. The document outlines which study changes require IRB

review and which do not, and notes that the US regulations allow immediate changes to be made in certain situations. Recommendations on informed consent are also provided. Adjust study starts and enrolment The document acknowledges that the impact of the pandemic on new and ongoing clinical trials has been highly variable and will continue to be so. The CTTI document recommends keeping participants informed about the risks of site visits and the precautions being taken to reduce these. A list of common precautionary measures that should be implemented is provided, most of which will already be familiar to study staff and participants. Remote monitoring Existing drivers for the move towards risk-based and remote monitoring have undoubtedly been reinforced by the pandemic. The FDA has issued guidance to help expand the availability and capability of non- invasive remote monitoring devices to facilitate patient monitoring during COVID-19, and the CTTI document makes several recommendations on the implementation of remote risk-based monitoring. Critically, in all cases, any change to an existing monitoring plan must be documented. Flexibility New levels of flexibility are needed to accommodate workforce issues, remote working, changes to study monitoring, different systems and platforms, different ways of performing study assessments, remote participant screening and changes to the informed consent process. The clinical trial environment, which has historically changed rather slowly, has seen unprecedented changes since March, highlighting the importance of flexibility. COVID-19 tags All changes implemented in response to the COVID-19 pandemic should be identified and documented. The CTTI document recommends the use of a “COVID-19 tag”– a standard template for recording items such as missed assessments – and clear procedures for documenting and communicating changes.

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Issue 469, 2020

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