May 2020 • PharmaTimes Magazine • 42
// COMMENT //
Stuart Henderson considers the need to transform clinical trials during COVID-19
We all know that most life sciences companies are working and collaborating tirelessly to develop tests and treatments for COVID-19. The importance and scope of that work cannot be overstated – it must take precedence as this crisis unfolds.
At the same time, though, life sciences companies must also advance the treatments in their pipelines that are essential for so many other human health issues. This is critical to navigate the immediate crisis and emerge stronger in a new normal. Continuing to progress treatments across clinical phases, while taking care of patients who are currently in clinical trials and depend on the therapy, is vital to world health and scientific progress.
Now more than ever, the industry needs to leverage the power of data, analytics and remote engagement at scale to improve how the clinical trials are run. Life sciences companies must engage, empower and enable patient access to clinical trials. That means leverage call centres and virtual methods to empower patients and provide information or access to clinical trials, care and investigational therapies.
Life sciences companies should also assess other areas that are experiencing disruption including getting the necessary clinical supplies to patients and alternative ways to deliver treatments that don’t require in-person meetings. Obviously, it is imperative to balance compassionate use for non-trial eligible patients and those who have stopped a trial with safety considerations.
It is also important to apply Health Authority guidance to maintain consistency in running clinical trials to assure safety, good clinical practice (GCP) compliance and trial integrity.
In the near term, it is essential to rationalise clinical trial priorities and ‘lean on’ virtual. This means redefining clinical trial prioritisation based on unmet patient need, study progress, supplies availability, and business objectives. Life sciences executives should rationalise priorities and reallocate resources, respecting the balance of trial sites’ bandwidth against portfolio demands. It’s equally important to assess the protocols for remote-patient monitoring, making sure they are both useful and feasible.
The next, longer-term step is for life sciences companies to rethink the clinical trial experience. The aim should be to humanise this experience and then build it across multiple trial sites. To do this, they need to reimagine the clinical trial experience by proactively co-creating the trial design with patients and taking a 360-degree view of the dimensions of their lives…as people.
Must-haves for life sciences companies include digital capabilities for remote-enabled trials to build resiliency into operations and care continuity. They should also prioritise creating full-scale digital capabilities that can speed time-to-insights for decision-making and drastically reduce onsite burden. Finally, they should re-examine where to hold clinical trials and the selection of alliance sites and service providers.
COVID-19 has shed light on the need to ensure that clinical trials continue, no matter what the circumstances. Continuing to progress treatments across clinical phases is a need that can be met with careful planning and the courage to embrace a new, more digital, more human way of serving patients in clinical trials.