REACTING TO A PANDEMIC


What did you have to consider when managing your trial around lockdowns? • How the COVID-19 infection would directly affect patients in trial, study staff, monitors, the trial management team and vendors.


• If my clinical trial would be temporarily, or even permanently, stopped.


• Whether remote monitoring and remote study management would be sufficient to secure patient safety, protocol compliance and study integrity.


• Whether the safety of patients who were in study progress at the time would be challenged by them not coming for regular study visits or receiving regular therapy.


• Whether my study supplies and investigational medicinal product would reach clinical sites/patients within the required time and in good condition.


• How my internal and external teams, partners and vendors would be able to continue their delivery in a virtual setting.


• How to recruit new patients to the study if they were prevented from arriving for elective procedures and regular exams.


• The number of protocol deviations to be faced and how to deal with them.


• If public pandemic preventative measures and local regulations would allow the proper management and continuation of my trials.


• How much my clinical trial costs would increase as a consequence of managing the trials around lockdowns.


What challenges did you encounter throughout the pandemic and how did you overcome them? There were various challenges that were faced during the pandemic. Some of them would have been anticipated, but others were unexpected


“COVID-19 has opened a door for the faster entry of methods supporting decentralised patient-centric trials. New technology, tools and services had been finding their way into trials but the whole process was stimulated and accelereated”


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because at that time it was difficult to predict the proportion and duration of the pandemic within the business continuity plans. Some of the main challenges observed included interruption of clinical trial supply chains, study management/monitoring, and staffing. • Interruption of the clinical trial supply chain caused by decreased manufacturing capabilities of vendors, but also problems in transport and deliveries of raw supplies to manufacturing/assembly plants, and transport of final products to clinical sites. Making orders well in advance and anticipating supplies and needs far more in advance than they would normally be planned and ordered, should be implemented in order to overcome clinical trial supply disruptions. Engaging and having a backup of several vendors/providers for the same items, and expanding a database of preferred or potential providers.


• Full study monitoring and management had to be moved to a fully virtual setting, ideally including access to full electronic medical records (EMRs) if available at sites. Access to sites’ EMRs was administratively demanding and time-consuming, therefore it is recommended that this be established at the start of each trial, automatically, if possible. Alternatively, full redacted source documents (SD) should be sent for verification by email to monitors where applicable, which requires additional time and resource of site staff.


• General shortage of staff and limited presence at sites during the pandemic made the overall monitoring and study management process more challenging, therefore alternative supportive site staff needed to be engaged.


Do you predict virtual trials will be a mainstay for oncology-based study or will they revert to traditional methods? With a direct pandemic experience, some of the virtual trial elements had to be introduced for the first time, or at least at the largest scales in running studies in order to mitigate the impact or to save studies. Some of these elements, which were proven as efficient in real world experience, will continue to find their area of use. This might include electronic Patient Reported Outcomes (ePRO), biometrics, telemedicine and e-Consent.


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