Call for new tech-first approach to disrupt clinical trials
Among the industries hit hardest by coronavirus is the global drug trial industry, which – while currently focussed on a possible cure for coronavirus – is also relied upon to create tomorrow’s treatments for the world’s illnesses and diseases.
Christian Hebenstreit is SVP and General Manager EMEA at Medidata, a SaaS platform for the clinical trial industry. He told BusinessCloud that the industry has seen a “huge drop in enrolment numbers” in major countries that conduct thousands of clinical trials, which is pushing back timelines for future treatments of all kind.
The UK saw an 80% decrease in patients entering trials year on year in March 2020, Hebenstreit said citing the firm’s recently published ‘COVID-19 and Clinical Trials: The Medidata Perspective’ whitepaper. Similar trends are also occurring across the EU and other affected countries.
In a typical clinical trial, a patient receives a drug or treatment in very controlled environment – the type now inaccessible during an international lockdown. Participants who would normally travel or enter controlled spaces such as hospitals or other sites can’t.
“The effects of the current crisis are huge and cannot be underestimated,” he said of the shake-up. And while pharma and biotech companies, as well as the FDA, the European Medicines Agency and the UK’s Health Research Authority have recognised the issue, he said that the industry needs to come together and modernise faster.
One of the adaptations he calls for is further introduction of new technology including wearables and AI – creating a new breed of ‘virtual trial’.
“We are starting to further utilise our data assets and essentially creating an exchange between human participants and data to help reduce the number of patients needing to physically interact with a doctor in a clinical trial,” he explained.
Consumer devices can now record what time a patient got out of bed in the morning, or how many steps they are able to do per day, he said. A typically test of health – asking a patient to walk for six minutes – could be catalogued via smartwatch.
“Patients would usually attend a live session in a hospital with a doctor to conduct this test. Now wearable technologies are enabling patients to conduct these same tests in the comfort of their home, all while monitoring heart rate and blood pressure results in real time.”
The measurements can be taken 24 hours a day, 7 days a week, and consequently improve the quality of data that we see as a result.
“28% of clinical trials can be completely virtualised, and most trials can have some virtual element, so the opportunity for virtual trials is huge,” he said.
“With clinical trials, a patient can stay home during a crisis and talk to his doctor via video, while still receiving their treatment in a controlled and safe environment.”
While he said that there will always be a proportion of trials that will require wholly physical presence in hospital, the virtual trials can reduce the number of times that patients need to physically visit a doctor at a site.
But for faster adoption of these new standards, at least as a temporary stop-gap, Hebenstreit said that the industry must work as one.
“We must come together as an industry - pharma and biotech companies, contract research organisations, non-profits, academics and regulators - to find ways to continue conducting clinical trials and ensure drug development doesn’t halt.”