The ongoing pandemic is affecting how clinical trials are managed, not just in terms of patient recruitment and immediate patient care but also in terms of data collection, analysis and safety reporting.
Health agencies around the world are assessing the impact of the pandemic and issuing new guidance on the management of clinical trials by sponsors and pharmacovigilance systems by MAHs at this time. This rapidly changing situation has meant that sponsors need to be more vigilant and proactive in determining the effects of the pandemic and changes in authority expectations in order to minimise the impact on safety reporting and to maintain patient safety. It is now more important than ever to request revised instructions and adopt regulatory changes swiftly to minimise disruptions to clinical trials. To effectively deal with this unprecedented situation, it is important to have an established and robust safety reporting solution.
Key health authorities, including the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and the UK Medicines and Health Regulatory Authority (MHRA) have released guidance for stakeholders, providing information and guidance on the conduct of clinical trials and post-marketing surveillance during the COVID-19 pandemic. Although these agencies acknowledge the challenges involved, it is expected that safety reporting activities should continue as usual because patient safety is the priority. However, some traditional methods of safety reporting may be more challenging during the pandemic.
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Challenges for safety reporting activities due to the COVID-19 pandemic
There is vast diversity in safety reporting requirements across the globe. Although many countries have adopted electronic reporting, such as the E2B gateway, portal entry and email, many agencies still use traditional methods of courier or hand delivery for paper reporting or electronic reporting by compact disc. Electronic reporting and email submissions are not currently directly impacted due to COVID-19. However, all methods demand efficient co-ordination amongst pharmacovigilance teams, local legal representatives, courier support and teams distributed across different geographical locations, for example with portal entry in the local language.
As discussed, a large portion of safety reports are still mandated to be submitted using courier or hand delivery to national Competent Authorities (CAs) and Ethics Committees (ECs) or Institutional Review Boards (IRBs). These reports include expedited (SADR, SUSAR and SAE) and periodic (PUSR, DSUR and line listing) reports. In the early stage of the COVID-19 pandemic, it was critical to pre-empt disruption to courier and hand delivery services from the sender or receiver due to government measures such as travel restrictions. Courier companies are at risk of delayed or failed deliveries due to the reduction in cargo flights, government restrictions in certain countries and the closure of recipient offices. In addition, authorities that normally expect a sponsor representative to hand deliver safety reports face challenges to work normally at this time.
The key to achieving safety reporting compliance
The COVID-19 pandemic has highlighted the importance of having a robust business continuity plan (BCP), ensuring a global footprint in drug safety specialists, efficient technology solutions and a strong and proactive intelligence management process.
The current challenges posed by the COVID-19 pandemic have also prompted regulatory agencies to reconsider their requirements and have emphasised the importance of electronic reporting to ensure data exchange for patient safety. Having a dedicated safety intelligence team enables an established communication channel with authorities and the support of local teams enables prompt and proactive communication with established contacts at regulatory agencies to arrange alternative measures in a short time frame, which is of the utmost importance during this period.
COVID-19 clinical operations
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Adapting operations to changing conditions
ICON has adapted its services to support sponsors during this time; offering remote monitoring where on-site visits were not permitted, providing additional support to get IMP to patients and pre-recording investigator meetings because of travel restrictions.
Lessons learnt from the COVID-19 pandemic to build a strong Drug Safety Reporting system
- The importance of electronic reporting:
This pandemic underlines how electronic or paperless reporting is the most effective reporting method.
- The importance of a robust and responsive intelligence process:
Access to up-to-date regulatory intelligence is key for a sponsor or MAH to avoid disruption to clinical trial or project activities, including fulfilling legal responsibilities for patient safety. A strong process for regulatory intelligence maintenance, a rapid change-implementation process and robust system to enter rule-based decisions can contribute to ensure compliance and quality.
- Established communication channel with agencies:
Beyond continuous monitoring of regulatory notifications, proactive communication with agencies helps agencies, sponsors and CROs to understand one another’s requirements and the challenges presented.
- Centralised system for submission oversight:
A system that performs automated reporting assessment, supports with generating and prioritising tasks, prepares submission packages, is capable of sending communications to various teams including for translation, courier, agency portal submission or for legal representative signature is key. Automation dramatically reduces risk of human error during challenging work situations such as at the time of a pandemic.