The coronavirus pandemic has proven to be the biggest health crisis of our generation, and has triggered an unprecedented global call to action across the pharmaceutical & lifesciences industry. It is impressive to see pharmaceutical and diagnostic companies respond with agility and pace, truly ‘upping their game’ to redesign trials and adopt digital tools which support patients and clinicians, and facilitate trial activity (e.g. through virtual patient visits and remote monitoring). Under normal circumstances, these quantum leaps would have challenged the highly regulated and traditionally cautious disposition of the industry, and change would have been slow.
It is equally remarkable to see how regulatory bodies around the world have matched the pace of the industry to ensure clinical trial continuity of both existing and new trials in the wake of this pandemic.
Despite channelling resources and efforts to support Covid-19 clinical trials, regulators have been quick to release new guidelines for sponsors that have ongoing, non-Covid trials. The overarching advice is that patient-safety is paramount when making any decisions on ongoing clinical trials, urging sponsors to weigh up the benefits of continuing the trial against the potential risk to participant safety. For instance, the European Medicines Agency (EMA) has advised that risk-based assessments be performed to understand the direct impact of Covid-19 and related government-imposed restrictions on trial participants and trial conduct. Based on the outcome of the risk assessment, sponsors have the option of conducting trials virtually, extending the trial, moving patients to non-affected risk areas, or temporarily halting the trial .
To enable trial continuity, sponsors have keenly adopted new approaches and technologies such as virtual trial management, virtual patient visits, wearables and smartphones. One example of this is Janssen Research's CHIEF-HF trial , where patients are monitored remotely via wearables. This trial will continue to run throughout the pandemic period with 1,900 patient enrolments.
Regulators have provided additional flexibility in the guidelines around usage of such technologies, depending, of course, on the risk assessment outcome and study design. For example, to enable new ways of working, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is working closely with a US-based biotech sponsor and conducted a virtual site inspection at the start of the pandemic in March 2020 . This example of collaboration and partnership between regulators and the industry is testament to the determination by both parties to do the best for patients and their families.
The unprecedented pace of change for ongoing trials has been paralleled by regulators and the industry for new Covid-19-related trials. All regulatory bodies (FDA, EMA, MHRA, PMDA) have been quick to release their own guidelines in an effort to encourage more scientific and clinical research on Covid-19 vaccines, treatments, diagnostics and medical devices. The FDA released the Coronavirus Treatment Acceleration Program (CTAP), a comprehensive program to spur Covid-19 research and patient participant recruitment into Covid-19 trials. It contains guidance around existing review pathways, accelerated procedure guidelines, and resources for patients. In parallel, the PMDA, EMA and other regulators also released their respective commitments and guidelines for Covid-19 trials.
It was under these new guidelines that Remdesivir, a treatment drug for Covid-19, was approved for accelerated conditional marketing-authorisation and compassionate use (FDA approved via CTAP as early as May 1 2020, quickly followed by Japanese PMDA, and EMA in June after a procedure that took less than one month). University of Oxford’s front-runner Covid-19 vaccine has also seen its regulatory procedures fast-tracked; UK’s Medicines and Healthcare products Regulatory Agency (MHRA) was able to assess and authorise the clinical trial in a little over one working week.
Such timelines are unprecedented. In normal circumstances, advances would have taken months and required multiple review points. Since the start of the outbreak, FDA has reviewed over 250 Covid-19 treatment trials , and more than 500 programs are currently in the planning stages. EMA is involved in nearly 200 trials for both vaccination and treatment of Covid-19 . Despite the difference in geographical jurisdiction, both regulators have been actively exchanging information on products and clinical trials. Such collaboration is evident in the Remdesivir trial, where FDA hosted a virtual meeting with EMA and other regulatory partners after authorising the antiviral treatment. Since then, these two prominent regulatory bodies have been meeting regularly to review progress and discuss insights to support regulatory decisions.
What we are observing here is how a heavily regulated industry, that was previously complex and slow to change, is moving at an unprecedented pace to find the right vaccine, treatments and diagnostics for Covid-19. Without the global call to action, this change would perhaps not have taken place. Covid-19 reminds the whole pharmaceutical & lifesciences ecosystem of the importance of agility to mobilise and move things forward, and adopt whatever tools necessary to save patients' lives.
If we extrapolate what the industry and their regulators have demonstrated in the recent months, we can hypothesize and speculate how different the end-to-end clinical trial process will look like in the future. Now we know what’s possible, some of these new ways of working will surely become the new normal.*
*For more information on this topic, please also read our article Covid-19: Has the pandemic re-imagined the future of clinical trials?
If you would like to talk to Baringa about the regulatory changes during Covid-19 and how these impact your clinical trial programmes, please contact Kate Moss and Faizal Roslan.
About the authors:
Kate Moss leads Baringa’s Pharma and Lifesciences practice. Faizal Roslan is a Senior Manager in Baringa’s Pharma and Lifesciences practice, and specialises in data management, digital R&D and regulatory compliance. We thank Auntora Sengupta, Senior Consultant in Baringa’s Pharma and Lifesciences practice, for ther contribution to this article. All three are based in our London office.
4. As of Aug 2020 – FDA website https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap
5. as of Sep 2020 -EMA website - https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines-covid-19