COVID-19: A New Era Transforming the Clinical Trial Landscape
This blog was authored by Fiona Maini, Global Compliance and Strategy Principal at Medidata. Fiona focuses on the evaluation of relevant regulatory changes coupled with the regulatory aspects of technological advancements and geo-political dynamics impacting the life science and healthcare industries. In this role, Fiona regularly interacts with authorities and industry bodies on modern tech strategies such as emerging patient-centric and clinical platform technologies.
COVID-19 continues to disrupt each of our daily lives, as well as touching every industry across the world—and healthcare is far from any exception. We are identifying and having to address new challenges that are appearing in today’s healthcare industry as a result of the global health pandemic.
[Read Medidata’s latest report on the global impact of COVID-19 on patient study enrollment and the response by world regulatory bodies.]
Early in 2020, we saw uncertainty in the clinical trials space as a result of COVID-19, with the industry experiencing a 75% decrease in new patients entering trials globally year-on-year in the first half of April. During the same period, the UK experienced a 98% decrease. In order for drug development and R&D to continue, this space has had to adapt, innovate and explore virtual options while the world has been paralysed under lockdown—and it’s had to do so quickly.
A regulatory landscape changing at unprecedented speed
In many regions, trials have been postponed and halted, and a clear concern amid the COVID-19 pandemic remains the safety of patients and staff involved with conducting clinical trials. Pharmaceutical companies and clinical trial organizations are making decisions regarding the safety and sustainability of current trials during the COVID-19 outbreak—which is not an easy task. The type of trial, trial design and safety of the patient is at the heart of this decision-making process. This also means that we are now situated in a rapidly evolving regulatory environment that is impacting the clinical trials ecosystem as we know it.
Given the unprecedented and humanitarian nature of the crisis, regulators have developed and published urgent guidance on the management of clinical trials during this COVID-19 pandemic, with guidance on the continuation of current clinical trials (either via postponement or cancellation), the initiation of new trials, and the acceleration of COVID-19 trials for vaccine development. Alongside victims of COVID-19, adults and children with cancer, rare diseases and other life-threatening conditions still need life-saving therapies and cures. Research into these diseases areas must therefore be continued, but need to have the right regulations in place to do so safely.
The sector rarely sees such an accelerated action to the development of new regulatory guidance on such a global collaborative scale. In the past few months, we’ve seen significant changes, including the World Health Organization (WHO) declaring a public emergency in January and simultaneously triggering global health threat plans.
Regulatory collaboration and alignment on a global scale
Once declared a pandemic by WHO in March, regulators and health organisations convened virtually, holding global regulatory workshops and meetings to discuss the pandemic. Subsequently, a swath of guidances for sponsors and stakeholders running clinical trials was released by regulatory authorities
Around the global, regional and national regulators have submitted guidance, and while there is a degree of alignment, there are nuances between guidelines and must be considered independently. There are several common themes, most notably patient safety. In addition to trial participants, safety and the safety of site staff and those conducting clinical trials is paramount. Organizations must maintain compliance with good clinical practice while minimizing risks to trial integrity. Another key area is COVID-19 risk assessments, with risks varying per trial, site, location and the disease state being studied. Across trials, COVID-19 risks are being explicitly addressed in independent risk assessments, and these risk profiles are helping to inform decisions on whether certain trials can be continued or halted.
A significant change brought by regulators also comes in the form of new protocol amendments, as patients in many instances are advised to stay away from hospitals due to existing health problems. With the circumstances brought by COVID-19, we are expecting to see a continued increase in protocol deviations—regulators are requesting that these deviations are well-documented to enable appropriate evaluation of the trial.
Patient safety is of utmost importance, and sponsors need to determine whether it is safer for patients to participate in assessments via phone, virtual visits, or an alternative location. With many onsite monitoring visits no longer possible, there is a rise in the use of centralized and remote monitoring programs.
We’re clearly seeing a shift to a different mode of operation with more virtual visits and interactions, remote and centralized monitoring, and investigational medicinal products being shipped direct to trial participants. While these concepts are not new and the technologies already exist to support these scenarios, the adoption has been massively accelerated during the pandemic and is likely to have positive long-term implications.
Support through this challenge-ridden COVID era
It’s important to track and respond to regulatory and law changes pertaining to clinical trials, and be a part of this conversation as an industry. Under normal circumstances, similar changes often take a long time to evolve and to be implemented, but given the speed and urgency of this pandemic, change is happening as we speak. Through data collection and analytics software, we’re able to see trends in enrollment, data entry, trial volume, consideration into alternate countries and sites to ramp up query response rates, and additional metrics to help diagnose risk areas. These insights can help companies make critical decisions about their ongoing clinical trials, and also allows regulators to try to mitigate some of these issues to ensure clinical research continues.
Many aspects across the clinical trial lifecycle can be executed virtually, supported by patient-centric technologies and unified software platforms enabling remote interactions and secure collection of real-time data and analytical capabilities. Regulatory guidance encourages and supports exploring alternative options like these.
Many companies in the industry are adapting and releasing tailored COVID-19 technologies at an unprecedented rate. For example, at Medidata we accelerated the launch of the myMedidata platform in response to COVID-19, with the first release of the platform enabling research organizations to follow COVID-19 symptoms for their ongoing and future clinical trials, and advance their scientific understanding of the virus—all done remotely. Given the social distancing restrictions in place, myMedidata is designed to keep patients involved and supported in all aspects of site and remote based clinical research, regardless of their location.
It has never been more important for the life sciences industry to continue with research across all areas, from COVID-19 to all other diseases and indications. With the aid of technology, virtual trials are now being realized and hold the key to powering smarter treatments and healthier people. COVID-19 has forced us to modernize the clinical trial ecosystem and become even more patient centric. Let’s hope this becomes the new normal in the post pandemic future.
To learn more about the changing regulatory landscape in light of COVID-19, please see a recent webinar we hosted as well as a list of other recent and upcoming webinars.