Rob Lenz, M.D., Ph.D.
Senior Vice President Global Development, Amgen
Industry experts are predicting major changes to the way clinical trials could be conducted in the future.
The clinical trial landscape is in the midst of a fundamental transformation.
Underpinning this change is the way data is generated for development of investigational new drugs and therapies, remote monitoring of patients, greater access to patient data and inclusion of broader populations in trials.
While COVID-19 has been a factor, Amgen’s Senior Vice President (Global Development) Dr Rob Lenz, M.D., Ph.D. believes it has been more of “a catalyst in terms of accelerating that evolution” rather than a key driver.
“We are in the midst of a fundamental shift in how we generate data to understand the efficacy and safety of potential new medicines,” continues Dr Lenz, who points to a “confluence of factors” re-shaping the design and execution of clinical trials.
Enabling factors include unprecedented access to anonymised patient data, advanced analytics and huge increases in computational power to interrogate large datasets, combined with increasing openness by global regulatory authorities to these new approaches.
Amgen – which discovers, develops and manufactures new drugs and therapies – says the access to vast amounts of real-world patient data is offering “tremendous insights” into understanding populations, treatments and disease progression.
“That is critical to understand how to design our trials in terms of what is the right population,” explains Dr Lenz.
In the extreme, he says that can obviate the need for placebos, by constructing a synthetic placebo or comparator arm, which reduces trial time, but also makes trials more attractive to patients as they have a higher likelihood of receiving a potential therapeutic.
In addition, virtual technologies have “unburdened” patients from the commitments associated with participation in trials, particularly given that many were unwilling to attend clinics to take part at the peak of the pandemic.
We are in the midst of a fundamental shift in how we generate data to understand the efficacy and safety of potential new medicines.
This, says Dr Lenz, created an “almost existential crisis” in the clinical trial landscape, causing industry and regulatory authorities to “pivot” to allow measures to support clinical trials without patients having to come to a site.
Solutions included direct shipment of study medicine to patients; passive collection of data direct from Electronic Health Records and monitoring via telemedicine and wearables.
The virtualisation of the clinical trial has also “opened the aperture” for broader populations to participate and help in the trial recruitment process. “This is the democratisation of the clinical trial,” adds Dr Lenz.