Medable is arguably the strongest company in the decentralized clinical trials space. If fundraising is any measure of success, the company has raised more than $521 million since its founding in 2012 — significantly more than its competitors, which include Curebase, Science 37 and Clara Health.
On Tuesday, Medable made its product offerings more robust by rolling out a new software solution. The software is designed to accelerate decentralized vaccine trials so pharmaceutical companies can better respond to disease outbreaks such as monkeypox, Covid-19 and flu variants. It is not the first company to launch software designed for decentralized vaccine trials — in fact, Curebase released a platform for at-home Covid-19 vaccine trials in 2020.
Medable’s “core” vaccine trial product includes a pre-configured set of modules that handle things like participants’ pre-trial screenings, electronic consent, televisits, electronic clinical outcome assessments and real-time data reporting. Pharmaceutical companies and clinical research organizations can deploy the core solution in as little as five weeks, Musaddiq Khan, Medable’s vice president and head of therapeutic area solutions, said in an interview.
The “flex” version of the vaccine trial product features all the same tools as the core solution, along with customized digital tools designed to meet a trial’s specific protocol needs. Examples of these customized tools include automated data access via sensors and wearables, more complex clinical outcome assessments, and integrations with additional electronic data capture systems and interactive response technology systems. The flex offering also lets pharmaceutical companies conduct trials in more than 60 languages.
This “off-the-shelf solution” eliminates much of the technical build burden for pharmaceutical companies and can reduce trial launch timelines from more than 12 weeks on average to as short as five weeks, Khan claimed.
“It’s important to remember that this is an efficiency solution that reduces the deployment time for technology that supports operational delivery of vaccine studies — the scientific questions that need to be asked are still going to have to be answered,” he added.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The rate of innovation in vaccine research was pretty low until the pandemic emerged, according to Khan. Now that scientific innovation is taking off in the vaccine space (think mRNA technology used in Pfizer and Moderna’s Covid-19 vaccines), it is time for operational delivery to modernize as well, he argued.
The pandemic demonstrated how quickly pharmaceutical companies can work to develop new products, and Khan believes that emphasis on speed should remain strong as they work to create novel vaccines for new variants of Covid-19 and the flu, as well as for monkeypox and any future disease outbreaks. Preconfigured decentralized trial software will be a key component to ensure that these pivotal vaccine trials are conducted as quickly and with a large number of participants, he said.
“Ironically, the lockdown kind of catalyzed people’s understanding that we can do trials remotely,” Khan said. “The industry made sure that our priorities of maintaining patient safety and data integrity were not compromised by using this novel approach.”
Research suggests that decentralized clinical trials are also financially advantageous. A study released earlier this year by the Tufts Center for the Study of Drug Development said that for decentralized Phase II studies, the one to three month reduction in deployment time yields a net financial benefit that is up to five times greater than the upfront investment required. For Phase III studies, similar deployment time savings can yield a net benefit that is up to 13 times greater than the required upfront investment.
Photo: Warchi, Getty Images
