WEBINAR: Decentralized clinical trials: The post-pandemic blueprint

Dec 8, 2020 - Dec 8, 2020,

Learn how to overcome challenges in remote data collection and stakeholder alignment to improve the patient experience and trial outcomes

COVID-19: A data challenge and a catalyst for new insights

The healthcare ecosystem has demonstrated its ability to share data to uncover new insights this year but there is more to be done, says Nigel Hughes, scientific director at Epidemiology, Janssen R&D



 
One of the key issues that arose during the pandemic, and arguably a factor that has led to more deaths, has been one of healthcare systems, public health and governments having insufficient or no relevant data on which to base critical decisions. The right data are not in the right place to answer the right questions at the right time.
 
Yet, in the midst of this we have also seen remarkable collaboration on the scientific response to the pandemic, from diagnostics to therapeutic and vaccine research and development. We have learned a lot about the virus since its genome was shared by Chinese researchers in January. 
 
Evidence at scale and at speed
A very significant learning has been the need for real world, observational data, in the right hands, to research applicable insights from the past, contemporary insights from today, and implications for the future management of pandemics. 
 
Studies of existing knowledge, such as the Observational Health Data Sciences and Informatics (OHDSI) study-a-thon held in March and characterising the adverse event profile of hydroxychloroquine in rheumatoid patients, as well as international observational and randomised trials of its lack of efficacy in COVID-19 treatment. 
 
The study-a-thon is ongoing, transitioning into the SCYLLA and CHARYBDIS studies. They have produced manuscripts published or in preprint on hydroxychloroquine, but also on the role of antihypertensives in COVID-19 patients, on characterising COVID-19 patients, and predicting critical care need versus historical seasonal influenza patients. 
 
Being able to conduct rapid observational research with commensurate quality, addressing the need today for a quicker time to an answer, pre, during and post pandemic is a real challenge for healthcare, and the industry. The approach taken by OHDSI is an indication of what can be achieved in generating evidence at scale, but also at speed.
 
However, problems remain due to the inadequacies of source record and data systems with poor interoperability and this has impacted on the ability to conduct adequate research. 
 
A model for future responses
Even worse, since real world observational research is poorly understood by the wider establishment, journals were unable to ensure the rapid publication and review warranted by a pandemic. It has been noteworthy that preprint articles and crowdsourced review became a norm during the first wave of the initial pandemic. 
 
Responding to the precariousness of real world data, the Innovative Medicines Initiative (IMI) European Health Data & Evidence Network (EHDEN) project, which was initiated in November 2018, was a partner of the OHDSI study-a-thon, but also initiated a rapid COVID-19 collaboration call in May, resulting in 25 selected data partners from eleven countries with relevant clinical data being harmonised to a common data model. 
 
The project is also collaborating with the European Medicines Agency on convergent areas of interest, but also in this time of pandemic, with regards to pharmacovigilance and pharmacoepidemiologic studies. Over the remainder of 2020 and into 2021, the project will be developing a COVID-19 sub-network and data partners will be able to collaborate within the OHDSI international network for ongoing research.
 
Other IMI projects, such as HARMONY, are working on COVID-19 calls, but also in terms of responding to the impact on routine care, such projects as Trials@Home are responding to the need for moving from how we have instituted clinical trials in the old paradigm to how we ought to be doing so in the 21st century, especially now in the light of COVID-19. 
 
These projects and initiatives developed as public/private partnerships and consortia, and pre-competitive collaboration by industry, with academia and others, can serve as a model for future responses to pivotal needs in society, not least among them pandemics. Indeed, multiple networks, collaborations and initiatives have expanded internationally over the year of the pandemic.
 
And of course, the pandemic is a reminder of how there are very few challenges in healthcare, if any, that can be addressed unilaterally.
 
Remote possibilities
The pandemic has acted as a catalyst for numerous developments in the clinical care setting, responding to the need to provide care remotely, and with an international phenomenon of patients avoiding and shunning hospital-based care out of fear of exposure to SARS-COV-2. 
 
Telemedicine has been growing in use over time, but it perhaps has not reached an optimal threshold for widespread, routine use in synchronous, asynchronous and/or remote patient monitoring. Lockdown and resource restrictions by stretched healthcare systems meant an opportunity for expanded adoption, though it remains to be seen what will happen post pandemic. 
 
Use of ubiquitous or ambient computing, through smart speakers and devices for example, has also seen a boost in adoption. The collaboration of Amazon’s Alexa and the NHS in England is a good example of new possibilities to support patients with information and advice outside of historical routes. Indeed, a COVID-19 risk calculator has been demonstrated as an Alexa skill at the OHDSI symposium in October 2020.
 
It has become clear in 2020 that many of our systems to deliver care in the health and social care settings suffered significantly due to pre-existing issues, insufficient resources, and funding gaps. Certainly, our information systems to ensure timely insight generation to support decision-making are not fit for purpose. Other channels, utilising dynamic media with real-time review and debate, on the other hand, served as critical factors in promulgating science.
 
As an industry, we will be heavily involved in supporting society in addressing post-pandemic health, economic and scientific challenges. Our output in terms of potential vaccines, as well as therapeutic interventions for the most critically ill will have a lasting legacy. For those working with real world data, and also in innovation, this crisis affords us an opportunity to move our healthcare paradigm forward and so accelerate better outcomes for patients.
 
Our thoughts must be with those infected and affected, those bereaved, and those exhausted in caring. Meanwhile, we have an opportunity to learn and to improve the world to reflect the needs of our 21st century global village, should we choose to. 
 
 

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WEBINAR: Decentralized clinical trials: The post-pandemic blueprint

Dec 8, 2020 - Dec 8, 2020,

Learn how to overcome challenges in remote data collection and stakeholder alignment to improve the patient experience and trial outcomes