The COVID-19 pandemic has forced the clinical trials industry to accept and accelerate the use of digital health technologies to alleviate disruptions and mitigate risks caused by the spread of the virus. Today, monitoring steps or sleep activity levels is almost as commonplace as checking the news. Smartphone tracking is gaining popularity as a contact tracing tool for COVID-19. And, video conferencing is increasingly replacing in-person meetings and physician visits.
Since the onset of the pandemic, social distancing measures and restricted travel decreased patient mobility and investigator and site availability - disrupting clinical trials and drug programmes. In fact, a survey showed that more than 75 pharma and biotech companies are facing significant disruption in their clinical trials. Further, approximately 67 percent of disrupted clinical trials were due to the suspension of enrollment, followed by the delayed start of planned trials at 18.4 percent and slow enrollment at 14.4 percent, according to an analysis conducted by GlobalData over the past four months. Within the 14.4 percent of trials affected by slow enrollment, more than 20 percent of these were due to the lack of availability of sites and investigators.
It is true that some clinical trials harnessed digital health technologies - such as wearables, sensors and apps - before the emergence of the pandemic. However, because of these disruptions, sponsors, clinicians and regulators are embracing its full potential, and using digital strategies to keep clinical trials moving forward.
Acceleration of digital health technologies
During this time where patients may not be able to visit sites for assessments, due to compromised immune systems or travel restrictions, digital health technologies can provide remote patient monitoring to collect vital data. Wearables and sensors can gather data on patients' biometrics and functionality, including gait, heart rate variability, sleep, glucose monitoring and sweat analysis, effectively capturing how a treatment or disease affects them everyday.
In addition, digital health technologies are being used for preventive monitoring. As wearables can detect changes in heart rate, sleep patterns and other variables, they may have the potential to detect whether an individual may be infected with the virus. By providing an early warning, wearables may be able to help prevent or halt transmission.
For example, a clinical-grade wearable developed by Sonica Health and Biomedical Advanced Research and Development Authority, called ADAM, can detect and monitor COVID-19 infections. This band-aid-sized wireless patch sits at the base of the throat, capturing data such as breathing effort, cough frequency and intensity, as well as duration, alongside cardiac information and temperature readings.
In another example, health officials in Brazil have ordered mass monitoring of blood oxygen levels among coronavirus patients, as patients may experience a shortage of blood oxygen, but not necessarily a shortness of breath, resulting in seeking medical help only when they’ve reached a critical point. Implementing the use of pulse oximeters - a device that measures oxygen saturation - patients can monitor their own blood oxygen levels, either continuously or several times per day, and share this information with their provider, ultimately preventing avoidable deaths.
Continued adoption of virtual trials and digital endpoints
The spread of COVID-19 challenged traditional clinical trial models, shifting to more patient-centered clinical trial designs, and rewriting protocols to allow for remote patient monitoring and in-home delivery, in addition to implementing other digital capabilities, such as telemedicine, to keep clinical research viable. Among major pharma companies, 60 percent are already using telemedicine for trial visits in response to the COVID-19 crisis, and more will follow.
The increased usage of smartphones and sensors in a real-world setting provided a gateway to the creation of digital endpoints. As more digital technologies enter the market and become increasingly integrated into clinical research, we will begin to witness a shift from digital endpoints used as supplementary to primary endpoints.
As patients are able to have home care options and remote monitoring, visits to sites and clinics will be reduced, further accelerating the adoption of the virtual trial model. Virtual trials also optimise the allocation of resources in hospitals and clinics to better manage patients infected with COVID-19 and other essential medical services.
Regulatory bodies around the world have been developing new rules that have allowed trials to continue, with home drug delivery, remote monitoring and the use of telemedicine. For example, the U.S. Food and Drug Administration released new guidelines for drug developers, which outlines critical features for conducting clinical trials and good clinical practice for investigational drugs. Additionally, recent federal regulation on interoperability for health data will strengthen efforts to integrate real-world data into drug development and regulatory decision-making.
COVID-19 clinical operations
Keeping your clinical trial on track in an evolving environment.
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.
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Increased pace of innovation
We are witnessing the beginnings of a restructuring of the clinical trials landscape. As countries reopen, there will be no returning to traditional models. In-home clinical services and other virtual trial elements will become a requirement in protocols to keep patients in trials.
Now, as clinical trials proceed, sponsors will be under immense pressure to determine the best way to quickly move forward with previously delayed trials. Additionally, pharmaceutical and biotech companies will need to plan for the next wave of challenges, as some trials resume or restart, while, at the same time, identifying and deciding how to address those trials for which data may already be compromised.
Moreover, in the absence of a coronavirus vaccine or treatment, global trials may continue to see disruptions amid regional virus resurgences, as some countries recover and others remain on lockdown. So, how can clinical trials be reimagined to better prepare for future disruption?
Drug and device developers will need to embrace innovation and plan for a future with evolving regulations, new digital technologies and transformed clinical trial designs. We will witness the industry pushing the boundaries on digital, data and analytics strategies, as sponsors continue to deploy remote assessment of vitals and use digital endpoints, increasing virtualization of trials. Combined, these factors can shorten timelines and decrease the costs needed to generate the essential safety and efficacy data needed for new therapy and device approval.
Moving forward, sponsors will need to consider the digital patient journey, as the demand for virtual trials continues to rise. As future crises emerge, or even the next pandemic, succeeding clinical trials will have to build in more flexibility for virtual and digital elements to mitigate risks and to prepare for uncertainty.
Starting new trials and sites in this environment can be challenging. Having a strategic partner can help. For more information on incorporating digital health technologies and digital endpoints in clinical research, read our latest white paper.Read the whitepaper
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