Almost overnight, the pandemic severely affected the ability to conduct clinical trials in safe and effective ways. During the first five months of 2020, according to a recent survey from Accenture, 77% of patients had their clinical trials halted or delayed because of COVID-19. Almost every effort in healthcare and life sciences focused on COVID-19 when the pandemic hit—but at the same time, according to this survey, 82% of patients reported that they were afraid to visit a healthcare provider.

Biopharmaceutical companies needed to accommodate these patient concerns and the reality that in-person site visits would not be possible in the pandemic environment. The industry moved rapidly to decentralized clinical trial methods using remote health tracking devices, patient apps, and telemedicine practices. “These technologies weren’t mainstream,” says Henry McNamara, senior vice president and general manager of Oracle Health Sciences. “But now they are. And they’re only available through the cloud.”

Although many biopharmaceutical companies had been slow to adopt cloud solutions prior to 2020, according to a report conducted by Informa Pharma Intelligence, 76% of respondents said that the pandemic had accelerated their adoption of decentralized clinical trial methods. Cloud solutions, such as Oracle Health Sciences Clinical One Platform, are bringing the benefits of AI, machine learning, and natural language processing (NLP) to clinical research.

Accelerating clinical trials

McNamara calls it ‘enabling the speed of science.’ “We don't want to be an obstacle to the science, whether that be developing tools and solutions, providing insights with predictive analytics, or helping ensure that our applications can be deployed quickly,” he says. “That agility enables us to deliver innovation as quickly as our customers need it.”

For example, AI is used to design clinical trial protocols and swiftly adapt them as necessary during the course of a trial, and to sift through thousands of data points to determine the prevalence of adverse reactions. Machine learning is used to manage information about clinical trial participants. NLP is used in chatbots that interact with study participants to schedule site visits and remind them to take their medications.

Indeed, over the past year Oracle technologies and thousands of employees have played supporting roles in the worldwide effort to combat the COVID-19 pandemic. McNamara created a tiger team of Oracle Health Sciences employees to provide 24/7 support to COVID-19 vaccine and treatment clinical trials running on Oracle Health Sciences software. From study start-up, to conduct, and closeout, Oracle Health Sciences systems were used to run these studies. Today, 145 COVID-19 studies across 70 customers are being run on Oracle Health Sciences systems.

In addition to supporting COVID-19 clinical trials, here are some of the other ways Oracle has assisted in the pandemic response:

• A system for the National Institutes of Health to manage the hundreds of thousands of trial volunteers—The CoVPN clinical trial volunteer screening registry was created in July 2020 to speed enrollment of clinical trial participants for COVID-19 treatments and vaccines. As of January 2021, it had enrolled more than 500,000 volunteers.
• Tracking the impact of vaccinations—People who receive their COVID-19 vaccination are using the V-safe After Vaccination Health Checker to report side effects, such as pain or nausea, for the first days, weeks, and months after injection. The Centers for Disease Control (CDC) can reach out to people who have experienced an adverse reaction, and medical professionals will use this data to better understand how different patients respond to different vaccines.
• Supporting global vaccination needs—Working with the Tony Blair Institute, Oracle donated the Oracle Healthcare Management System to manage the distribution of yellow fever vaccine in Africa, as a precursor to the massive vaccination program that is expected to come into place with the COVID-19 vaccine. The system helps country leaders create cloud-based electronic health records systems to hold in check major diseases and save lives.
• Supporting COVID-19 drug research—Soon after the start of the pandemic, Oracle started providing medical researchers with the cloud credits they needed to spin-up massive research projects focused on COVID-19 treatments and vaccines, including the University of Bristol team that is developing more effective antiviral drugs for COVID-19 and the Wake Forest Institute for Regenerative Medicine which is using miniaturized organs—organoids—infected with COVID-19 to look for treatments.
• Tracking drug therapy effectiveness—Oracle donated the Therapeutic Learning System to the United States government so physicians and patients could record the effectiveness of promising COVID-19 drug therapies.

Many of the changes that have taken place over the past year are likely to be permanent, but McNamara says that the pharmaceutical industry needs to start advocating for regulatory changes to forestall a swing back to the old ways of doing things. “Pharmaceutical companies have been doing everything they can to bring vaccines to the world as fast as they can,” says McNamara. “A lot of the advances over the past year came about because people were willing to throw everything into it, but that’s not sustainable. There have to be systemic changes. Companies have adopted new cloud technologies and platforms to enable decentralized clinical trials, and they want to maintain these positive changes permanently.”

Dig deeper

Photography: Coldsnowstorm/Getty Images