Director, Scientific & Regulatory Affairs, IFPMA
The biopharmaceutical industry and regulatory authorities have been working to ensure clinical trials have been progressing in all diseases throughout the global pandemic.
When the COVID-19 pandemic began, most of our focus went to ‘how can my family and I stay safe?’ and ‘will we have medicines and vaccines that will treat or protect us?’ While this was on top of our minds, the biopharmaceutical industry, clinical trialists, regulators and others needed to think about keeping clinical research moving ahead for other diseases, while continuing to supply medicines to patients currently enrolled in clinical trials.
Novel technologies and processes
Lockdowns, stay-at-home recommendations and movement restrictions all had an impact, especially on patient enrolment in new clinical trials and access to existing research sites. Keeping participants safe while maintaining the integrity of clinical trials was a priority.
New technologies have helped improve recruitment of volunteers as well as conduct, monitoring and data capture of clinical trials. Regulators instituted ‘regulatory agilities’ (processes that could be sped up or improved) to keep clinical research going. E-signatures were allowed, provisions for ‘remote/at-home’ patient check-ins and medicine deliveries were made and scientific advice processes were expedited. If not for regulatory agilities, years worth of data might have been lost, especially for cancer and dementia trials.
What about the progress that has been made? Most regulatory agilities established have a short life span and will end with the pandemic. Is there a way to keep regulatory agilities that have proved beneficial?
If not for regulatory agilities, years worth of data might have been lost, especially for cancer and dementia trials.
Leverage learnings and opportunities
Clinical trials are designed to deliver outcomes – whether positive or negative. We should continue to modernise and look for methods that deliver results more efficiently and effectively without sacrificing quality, efficacy or safety.
Modernisations in clinical trial science will help us adapt more quickly to external events, like pandemics. It also allows us to design trials that adjust to advancements in medical science, e.g. gene-based therapies and promotes using digital tools to increasingly capture and utilise real-world evidence. More remote/real-time monitoring of trials may reduce costs, improve data quality and reduce our carbon footprint.
We must talk about what is in the best interests of patients and what makes the most sense from a scientific perspective. It won’t be easy, getting everyone to agree on a way forward never is, but best practices are best shared. We must strive to keep the learnings from this pandemic foremost in our minds and explore how they can be applied to the future for global health.