Clinical Trials in a Pandemic: How COVID-Era Innovation is Driving Industry Change

With COVID-19 causing widespread disruption in research, companies are forced to quickly adapt to the current restrictions in order to do their work. Mitigating risks caused by the spread of the virus has caused an accelerated adoption of digital health technologies. Telehealth, wearables, and mobile tech are now being integrated into clinical research. This shift benefits the pharma companies, insurance companies since new products are being developed –  while also increasing health outcomes. Digital monitoring  increases patient compliance for taking their medications and engaging in healthy behaviors.

In June, new patient enrollment in U.S. clinical trials was down 38% compared to pre-pandemic levels.1 This was better than the figures in April, where patient enrollment was down 70%, but the lasting downtick had a significant impact on the industry. On top of travel restrictions and safety concerns for vulnerable patients, the growing politicization of the coronavirus led to hotspots across the US seeing a skyrocketing caseload, and hospitals are forced to preserve bed capacity for COVID patients, restricting visits for the patients of those clinical trials that are still done on-site.

As patient mobility and site availability decreased, many companies pivoted to a hybrid trial method: using existing testing paradigms where possible and opting for digital health technologies out of necessity, bringing clinical research into the digital realm.

Many of these new digital health technologies are wearables – sensors that gather biometrics like gait, heart rate variability, sleep cycles, glucose monitoring, measuring how a treatment affects them every day. Some of these metrics can be gathered with a simple smartphone. Janssen, the Johnson & Johnson’s pharmaceutical arm, is launching a completely virtual clinical trial, looking to enroll 1,900 adults with heart failure in a smartphone study, counting daily step counts and stairs climbed.2

Companies that require on-site testing are increasingly leveraging clinical trial support platforms. Trial operators from Signant Health have distributed equipment to protect research staff and made it easier for patients to reach trial sites by coordinating private transportation. The company offers patients private transportation to and from the location to ensure patient safety.3

For those embracing the hybrid model, trial patients are given the choice to take the medication at home and be monitored remotely. For those who choose to stay at home, trial medications are now shipped directly to these patients’ homes. These participants are monitored by wearable devices and check in on telehealth platforms. Follow-up blood tests that were previously conducted at larger research institutions are now performed in local labs and independent clinics.

As a result of so many inputs, we have seen life science organizations face challenges with consuming, cleansing, and aggregating such high volumes of disparate data. From efficiently capturing the electronic patient-reported outcomes, to aligning & automating the activity and biometric data across internal applications, companies are looking for new ways to streamline their data pipelines so that employees can focus on value-add activities. At Stratos, we’ve assisted our clients with a variety of these challenges and continue to evolve and support these growing needs – all while working remotely.

In some cases, the pandemic hasn’t been so much a swerve as an acceleration of pre-existing trends. In person examinations have been on a downtrend for a while now – physicals, for example, have been in decline for 2 decades now.4 Physicians increasingly rely on blood tests and imaging tech to catch symptoms that are missed during a regular physical. Other factors have certainly contributed to this decline as well: insurance companies have imposed time constraints on exams. Going forward, the current necessity of virtual learning has made it nearly impossible to practice the skills necessary to even perform the physical exam.5 The methods that have replaced on-site physicals, such as telehealth virtual appointments combined with labs, are all being adopted by clinical research. With COVID caseload rising steadily, it’s too early to predict if telemedicine is here to stay or if the traditional methods currently deemed “exposure risks” will make a comeback.

With all the talk of “future proofing” the industry, true progress is mostly borne out of necessity. While a COVID vaccine is still months or years away, clinical trial enrollment in European countries has come back up to normal levels, and pharmaceutical and biotech companies will already need to plan for the next wave of challenges. Device developers will need to not only embrace innovation, but plan for a future with evolving regulations about using patient data. It is likely that demand for virtual trials will continue to rise, and this is a critical time for the industry to push the boundaries on digital strategies.

Article by Veronica Shlyaptseva

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