The speed, flexibility and strong risk-benefit ratio of virtual clinical trials could all be highlighted in the assessment of potential Covid-19 treatments, according to industry bosses.
Dr Calvin H Knowlton, chairman and CEO of US healthtech firm TRHC (Tabula Rasa HealthCare), believes the use of new technologies such as AI in predicting medication safety could provide “a win for everyone” by keeping patients healthier and safer — even after the pandemic has subsided.
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TRHC recently announced a partnership with Washington-based health plan provider Regence to virtually trial several different Covid-19 drug candidates, and assess the risk of adverse drug events (ADEs) in each.
Matt Hafermann, a clinical pharmacist in case management at Regence, said: “As Covid-19 has shown us, when novel viruses or diseases are discovered, having another method to pair with conventional clinical trials will help accelerate the scientific knowledge for treatment and prevention of diseases.
“Due to the global impact of Covid-19, collaboration between all sectors of healthcare is essential in identifying, assessing and developing therapies to minimise the virus’ impact.
“Through this partnership, we can help contribute to a long-term recovery plan that prioritises health and safety, while sharing results that aid other researchers working on strategies to combat Covid-19.”
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TRHC-Regence partnership
TRHC announced earlier this month it would be using its MedWise technology, which predicts health outcomes by providing patients with a “risk score”, in collaboration with Regence.
The latter is offering de-identified medical information from about 500,000 of its members to TRHC, which will then use its risk-scoring analysis to simulate what is likely to happen if a particular medication is added to a patient’s existing drug regimen.
This will allow TRHC to assess the “safety profile” of potential Covid-19 treatments — as well as the likelihood that they will cause ADEs — across large, diverse populations.
Dr Knowlton also hopes this collaborative effort will demonstrate the value of TRHC’s MedWise technology in predicting medical expenditures associated with ADEs.
“By ‘virtually’ adding each repurposed Covid-19 drug, and combinations thereof, to a de-identified Regence member’s medication regimen, we can identify which coronavirus therapies will be least unsafe for subsets of members — without exposing anyone to these drugs or to actual harm,” he added.
“In addition to the clinical data about these off-label Covid-19 therapies, Regence will receive actionable insights on its members’ MedWise risk scores, which can be used to prevent harm to these members.”
Dr Jacques Turgeon, chief scientific officer at TRHC, said the company’s virtual clinical trials alongside Regence will focus on malaria medications hydroxychloroquine and chloroquine, separate combinations of both hydroxychloroquine and chloroquine with the antibiotic drug azithromycin, and Kaletra (lopinavir/ritonavir), which is traditionally used to treat HIV/AIDS.
All of these potential treatment options for Covid-19 are re-purposed, existing drug therapies.
“This type of information will help inform both pharma industries, and regulatory agencies, about the safety of new and repurposed drugs in different populations of patients with various drug regimens,” Turgeon added.
“Importantly, repurposed drugs, even though they have been on the market for a while, may not have been used in patients with chronic diseases and polypharmacy.”
TRHC also previously said the results of these trials should be ready for publication within 60 days of originally announcing the partnership on 9 June.
Benefits of virtual clinical trials
One of the key advantages trialling drug candidates virtually holds over more traditional testing methods is flexibility, according to Turgeon, which will allow TRHC to add new Covid-19 treatments into its study as and when they become available for use.
“Virtual clinical trials are going to be crucial for understanding drug impact and more broadly medication safety as we navigate the pandemic and Covid-19,” Turgeon added.
“A major advantage of virtual clinical trials is the speed at which data can be generated in a safe manner.
“In the current situation, the risk-benefit ratio of proposed repurposed or new therapies is difficult to determine, as there is not nearly enough evidence on the efficacy of the proposed treatments nor on their safety. Our virtual approach rapidly provides information on the safety of each therapy.
“By understanding how safe the treatment is for an individual, we can help to determine whether the benefit associated with the use of a certain drug in conditions such as Covid-19 is worth the risk.”
