December 22, 2020
The monumental challenges brought about by the Covid-19 pandemic have forced the healthcare and life sciences industry to think creatively to develop the best, most efficient solutions, systems and processes to help clinical researchers deliver safe and effective treatments to the public faster.
As a result, many life sciences companies are now looking to build on this momentum and retool their approach. They’re eager to take advantage of all available resources, technologies and digital capabilities, to execute their clinical trials with greater speed and quality. One of the most significant initiatives accelerated by the pandemic is the drive towards decentralised trials, with protocol designs, technology and processes that support greater remote participation in research.
The need to provide regulatory support and flexibility for patients in ongoing trials (those who’re in closed locations and have limited mobility due to the pandemic), has helped to define and scale the decentralised approach. New processes may now include data collection and visits at home, as well as virtual, remote, and ‘site-less’ trial design and participation strategies. The aim is to make clinical trials easier and more accessible for patients globally by reducing the burden and cost of travel and participation.
While Covid-19 is the greatest global health challenge to emerge in a generation, and the medical research community has come together to fight it, there is an urgent need to apply some of Covid’s lessons to treatments for other diseases, currently in development, that represent urgent, unmet medical need. “By drawing on the latest technologies, and finding creative solutions to collect and analyse data from all sources, we can empower clinical researchers to focus on finding necessary cures—no matter what the virus or disease is,” says Katrina Rice, Executive Vice President, Professional Services at eClinical Solutions, a company providing essential trial software for clinical researchers and healthcare professionals.
As a show of solidarity during the pandemic, the #NoGoingBack initiative was launched by industry professionals to unite the research community to continue the momentum and collaborative work created over the past several months. It is a statement from organisations across the world to continue pushing forward and improving clinical trial conduct globally.
Using every tool
As with most industries, Covid-19 has turbo-charged the search for digital-first solutions to complex problems. The clinical trial sphere is no different. Reducing the enormous average cost of a trial is key and an area in which a careful shift to digital can help. Last year, to get a drug through registration in the US, inclusive of failures, cost $2.6bn. The process is complex, consuming a great deal of time, energy and resource, and involving significant risk.
“Will a digitally transformed clinical trial somehow emerge out of this collision of social, mobile, analytics, cloud, and the traditional and evolving clinical trial process? I think the answer to that is a significant yes,” says the Chief Information Officer from one leading mid-market company in the industry.
Discussing key innovations in clinical trials and how to stay ahead of the digital health revolution, the Chief Information Officer adds: “Define digital transformation for yourself. Be aware of the shift in the computing model and respect the fact that the model is shifting and that it will impact clinical trials in a big and material way. If we want to be out in front of that, and if we want to embrace that and we want to innovate with that, then really there is a massive opportunity for us.”
“We could take our robust clinical trial process and use digital transformation to take it forward to advance the needs of our patient populations – that’s an extraordinary and noble concept.”
Data driving digital health capabilities
Many life sciences companies are looking for ways to transform their approach to become data driven organisations with digital health initiatives and new capabilities. This makes the challenge of maximising value from data even more critical. To do so requires an organisational approach and vision around data strategy.
For one top global biopharmaceutical company, real-time access to more varied and higher volume clinical data streams was a vital initiative, and part of an overall R&D architecture design to support digital health capabilities.
The company in question adopted the elluminate clinical data platform from eClinical, using it as a central clinical data workbench that automates the data pipeline and provides one true source of data that all clinical teams can work from. By improving clinical data access and review processes, elluminate brought detailed insights to the organisation’s key stakeholders, at a speed that enables the growth of its global health initiatives.
According to the client’s clinical programming lead, and the project’s key sponsor: “With this new infrastructure, we now have a single access point for clinical trial data. This allows us to disperse, review and consume that data as we need to. What has been a key benefit to this new data management plan is that it has been seamless. The elluminate platform easily integrates into our current architecture and promotes data visibility and flow for streamlined, governed access. This ultimately leads to far deeper insights, and helps us achieve our goal of transforming lives through science.”