Clinical Trial shift in response to COVID-19
The COVID-19 pandemic has devastated the world and has left significant lasting consequences on many sectors, particularly the clinical research and clinical trials industry. Clinical trials are an essential component of the drug approval process and provide vital information about a drug's safety and efficacy profile. As such, the disruption of clinical trials causes significant delays to a company's product portfolio and increases financial costs for clinical studies. The pandemic resulted in about 80% of non COVID-19 clinical trials having to press pause or shut down causing major disruptions to the industry. Furthermore, more than 2,000 trials have been stopped since the pandemic began, highlighting the consequential effect of the COVID-19 pandemic.
Many key stakeholders in the clinical trial sphere were affected by the pandemic. Government restrictions on travel, worldwide lockdowns, self isolation and social distancing requirements and the constant threat of infection to trial staff/participants were all major challenges faced by key stakeholders.
A qualitative study conducted by the Tufts Center for the Study of Drug Development studied the impact of COVID-19 on clinical trial execution by collecting information from clinical operations professionals at pharmaceutical companies in the United States. 23 out of the 25 organisations involved reported some level of impact on ongoing trials due to COVID-19. 11 organisations stopped ongoing trials and enrollment for a month, particularly in trials that were considered high-risk for COVID infection such as pulmonology, immunology and cardiology.
Patient enrollment and recruitment was greatly affected by the pandemic due to patient safety concerns and government imposed travel restrictions and lockdowns. Results from a retrospective cohort study examining more than 62,000 clinical trial activations during the pandemic found the number of studies initiated in the United States from February to May 2020 was only 57% of what is normally expected. Additionally, the requirement for social distancing and self isolation negatively impacted trials leading to staff/participant shortages.
These challenges forced clinical trial sponsors to employ other trial models such as decentralised clinical trials (DCT) and adopt digital health technologies such as telehealth visits and remote patient monitoring. Organisations such as the FDA implemented guidelines on how to continue trials during the pandemic, allowing investigators to use these digital health technologies and deliver drugs to participants' homes, or use online platforms to consent to taking part in trials.
Digital health technologies
The use of digital health technologies can alleviate many of the disruptions caused by the COVID-19 pandemic. Self isolation and social distancing requirements can be mitigated through the use of telehealth visits and remote patient monitoring. Digital health technologies such as wearables and sensors allow clinical trial investigators to collect information on a patient's heart rate variability, sleep, blood pressure and glucose monitoring to demonstrate how a treatment may be affecting them daily. The use of wearable devices and sensors makes it easier for individuals to participate in trials and gives investigators access to diverse patient populations. Additionally, using these digital technologies ensures patients and investigators remain connected at all times. According to Kaiser Associates and Intel, 70% of clinical trials will utilize some form of wearable sensors by 2025, highlighting the importance of this technology in future clinical trials.
Examples of the use of wearables in clinical research can be seen in a study published in Nature Medicine, highlighting the use of wearables to detect positive cases of COVID-19 by monitoring changes in heart rate, sleep and activity levels. Likewise, a partnership between Sonica Health and BARDA developed a wearable patch that sits at the base of the throat recording data on cough frequency/intensity, breathing effort as well as temperature and cardiac information. This allows them to detect and monitor COVID-19 infections. Therefore the acceleration of these technologies within the clinical trial sector proves valuable.
Decentralised Clinical Trials (DCT)
The popularity of decentralised and hybrid trial solutions exploded during the pandemic, particularly when the FDA promoted the use of virtual visits and remote patient monitoring. A report on DCTs during the pandemic, demonstrated a 76% increase in the use of DCTs during this period. While DCTs have many benefits for sponsors such as improved patient recruitment and retention and patient diversity, they also have many additional benefits obtained through the continuous collection of real-world data. The collection of data directly from the patient decreases the likelihood of missing data reducing variability and the collection of real-world data allows investigators and sponsors to predict adverse events and identify data anomalies in real time reducing errors. Similarly for patients, DCTs make it easier for them to participate in trials and reduce any burden associated with repeated site visits. As DCTs are a relatively new framework that may not be suitable for all trials, ICON, a clinical research organisation offers a range of services to assist and develop a solution that works specifically for your study.
With these new modern approaches come many data considerations for trial sponsors before adoption of these methods. Data surveillance, integration and interoperability of the digital health technologies is crucial, as integration of data collected from different devices can prove challenging. Furthermore, accessing data from electronic health records and other databases can have security and privacy concerns as can be seen in the recent hack of the Health Service Executive (HSE) records in Ireland. Lastly, more clarity is required from regulators on how data generated remotely through digital technologies can be used as regulatory requirements differ between countries.
Although all these factors need to be considered in the modernization of clinical trials, the shift in focus to decentralized approaches and digital technologies proves exciting in the very tightly regulated field of clinical research and trials