Trifecta Clinical Accelerates the Development of COVID-19 Treatments
The race to develop treatments and vaccines for COVID-19 is underway around the world, and speed is the name of the game. But ask anyone in the scientific community and they’ll tell you: Speed and clinical development don’t always go hand in hand.
On average, vaccines traditionally require development timelines of 10 to 15 years. Thousands of drug candidates never make it to clinical trials; of those that do, only 14% that begin clinical development are approved by the Food and Drug Administration.
Researchers are currently testing 54 vaccines in clinical trials on humans, and at least 87 preclinical vaccines are under active investigation in animals, according to The New York Times' Coronavirus Vaccine Tracker (as of November 2020).The urgency to contain the global pandemic has ushered in new ways of accelerating clinical development processes, and technology is playing a major role in doing just that.
Trifecta Clinical is one provider on the front lines transforming clinical trials. The company is the industry leader in process automation for clinical trial training and communication. To support the development of COVID-19 treatments and vaccines, Trifecta decided in early March to offer its services for free—and avoid delays caused by the weeks-long procurement process.
“If it was my family that was in the hospital waiting for these new therapies to come to market, I'd want them available as quickly as possible,” says Trifecta Clinical Founder and CEO Dave Young of the company’s decision.
Powering Faster Clinical Trials
Founded in 2005 and based in Los Angeles, Trifecta Clinical facilitates operations among clinical trial sponsors (e.g., pharmaceutical companies), clinical research organizations (which monitor trials on behalf of sponsors), the research sites (e.g., hospitals), and the Independent Review Board (which is responsible for protecting patient safety). This coordination ensures that the protocols of a given study are followed, and it protects patient safety.
The study sponsor must ensure research site personnel (nurses and doctors) are properly qualified to perform the procedures for a given clinical trial. Over the last 15 years, Young says, Trifecta has been enhancing and perfecting InvestigatorSpace, its clinical qualification management system (CQMS). InvestigatorSpace validates that the qualifications of all personnel are up to date for the duration of the study, and offers remote training for personnel to complete.
“An important component of what we provide is the ability to prove that a user has viewed the information,” Young says. “Trifecta’s proprietary Watch Code™ system builds a detailed audit trail of user participation without adding any additional duration to the training content.”
Trifecta’s technology also helps site personnel avoid unnecessary and redundant training, saving significant amounts of time. Over a four-year period, InvestigatorSpace has saved more than 98,000 hours of redundant training for one top-12 pharmaceutical company.
The ability to seamlessly switch from in-person to on-demand training was a major value-add in the wake of the pandemic. Trifecta was able to support development for many of the leading COVID-19 treatment programs—including vaccines, monoclonal antibodies, and immunosuppressants—run by pharma’s biggest players.
In March, Gilead Sciences used InvestigatorSpace to get its first COVID-19 trial up and running in only two weeks, even as the world adjusted to working remotely.
“Many companies did not have institutional experience using remote learning tools for clinical research,” Young says. In fact, many organizations relied exclusively on in-person meetings before the pandemic. Since then, Trifecta’s InvestigatorSpace has provided virtual training to more than 13,000 healthcare providers.
Under the Hood of Trifecta’s Fast, Reliable Software
Today, Trifecta is working with seven different pharmaceutical sponsors across 23 different studies related to COVID-19 research. The company’s ability to respond to the current crisis quickly with reliable, easy-to-use, and accessible solutions comes down to its investments in improving its software.
“Ultimately, our entire business is about presenting different views of data to different stakeholders,” Young says. The company invested in modernizing its data infrastructure to drive speed and efficiency internally—and benefit its partners by extension.
All vendors and systems used in human subject clinical research require varying levels of qualification and validation. This ensures that all systems used meet both sponsor and regulatory requirements. These processes occur before work on a clinical trial can begin. Creation of validation and sandbox environments was a painstaking process that could take weeks prior to Trifecta’s investment in a programmable data infrastructure platform.
Now, Trifecta can spin up these environments within 30 minutes. The platform easily automates data delivery across all phases of application development, testing, and release. Developers are able to securely manage and distribute policy-governed copies of production-quality datasets. The time saved by the data platform accelerates study startup, allowing research sites to begin enrolling patients sooner. This acceleration was especially critical for COVID-19 clinical research.
“These are high-visibility, incredibly important studies,” Young says. “The ability to get customers onboarded quickly and understanding how the system benefits their trials is a true game-changer.”
To date, Trifecta has supported COVID-19 trials at more than 1,100 hospitals and research sites in 24 countries. Trifecta’s investment in making data agile saved months of time getting research sites up and running—and solving one of the world’s most urgent challenges.
Digital Innovation in Clinical Trials
For 2020, Trifecta is donating 100% of its services to any COVID-19 clinical trial, says Young. By the end of the year, Trifecta will have donated nearly $7 million in services. And while the pandemic has had many negative effects, it has also ushered in an unprecedented era of cooperation, transparency, and data sharing among typically fiercely competitive companies and institutions.
Additionally, lessons learned during this crisis have led to changes that will provide lasting benefits long into the future. Trifecta will continue to be at the forefront of providing solutions to future waves of change impacting the industry.
Read more stories about data-driven innovation in the 2020 issue of Data Company Magazine.