The pharmaceutical industry faces an important inflection point in its approach to clinical trials and it’s one that COVID-19 has thrown into even sharper relief.
The last great change for studies was the advent in the early 2000s of electronic data capture (EDC). At the time there was a significant amount of resistance to EDC, but now it’s rare to hear about the collection of trial results using paper in all but the occasional single site investigator study.
Now, the major advance that’s available to pharmaceutical companies is in the amount and range of data they have access to and how it can be applied to the risk-based monitoring and remote monitoring of studies.
Joseph Goodgame, Remarque Systems’ chief technology officer and co-founder, explains what’s driving this shift: “Technology is barrelling along at a super-fast pace in all aspects of our life and patients have an expectation that technology is available to them, whether it’s by ePROs (electronic patient reported outcomes), telemedicine visits or other tech advances.”
The current situation with COVID-19 has driven a huge amount of digital transformation across healthcare, and that’s certainly proving to be true for clinical trials.
“The pandemic has escalated these changes within pharmaceutical companies, because the old model of a patient going to a site and having all of their data collected at that site, and then a clinical monitor going out and checking the data at that site has become less valuable in the current climate,” Goodgame says.
This includes telemedicine tools that support decentralised trials, remote monitoring technologies and machine learning tech that enables more timely review and analysis of large datasets leading to identification of potential issues and anomalies much earlier in the process.
But, despite the justified excitement surrounding clinical trial evolution, there are still a number of barriers preventing sponsors from fully embracing these technologies.
Remarque’s solutions service director Kristin Mauri notes, for example, that there are few incentives for the industry to change from a regulatory perspective.
“Agencies across the globe have put out a lot of regulations and recommendations around how to use technology to do things differently, but they’re not actually auditing companies against them, so there’s no consequences for sticking with the old way of doing things.
“Although everybody is aware that the regulations have changed, few people regularly follow them.”
In addition, technological capabilities have outpaced the skillsets of many of the individuals tasked with working with them, creating some important coaching needs.
“People in the industry are not always as data-literate as you might expect,” says Mauri. “We need to get over this hump and retrain the industry to work differently, to look at data differently, and to become more comfortable with taking a risk-based approach.”
Mauri says that in the past the industry has taken a ‘bottom-up’ approach to data, which makes it harder to identify issues in real-time compared to the ‘top-down’ approach needed for successful risk-based monitoring.
This data problem also points to a wider issue with drug development, Mauri says.
“People do things the way they’ve always done them because it’s proven to work and because trials are so expensive. There’s a lot of pressure on teams to just get through the process and doing anything new can be intimidating because they then feel as if they don’t have control and can’t meet deadlines.”
Finally, most current trial management platforms were not designed with these advances in mind, and the landscape has evolved so rapidly that many have struggled to keep up.
“The way clinical trials are executed is going to fundamentally change over the next few years, but legacy systems were not designed to be able to evolve with that,” says Mauri. “Companies need a foundational platform that’s able to take them into the future as we move towards things like decentralised and patient-centric trials. What’s out there today is not built to do that.”
“We’ve spent five years honing this platform to a point that it can cope with the current changes to clinical trials. It’s not a quick fix; it’s like back in 1998 when Jeff Bezos said Amazon was going to be a data company. It was a big decision we made way in advance of when the industry actually started leveraging these capabilities.
“That was a quite risky move for us as a young start-up company. We could have taken the solid, well-established approach, but we decided to do things differently.”
In practice, this means the company has had to focus on being as flexible as possible.
“What’s unusual about our platform is that you can use it as-is with traditional trial methods, or you can have a completely decentralised trial with telemedicine tech, etc,” says Michael Arlotto, president and co-founder at Remarque. “Once they upskill their data literacy and get comfortable with the system, all of the data capture methods and technologies behind it will look the same to the end-user.”
Arlotto and Goodgame founded Remarque in 2015 based on the idea, as Arlotto puts it, that “there had to be a better way to manage clinical trials”.
“We had both worked at a large global CRO in the past, and while there it felt like we were always a few steps behind the trials. We never had the ability to manage studies in real-time or near real-time as data flowed into the system. It always depended on data being transferred a month later, or even a quarter later.
Arlotto and Goodgame wanted to find a way to give clinical trial managers visibility on data in real-time.
“We wanted to see data from studies at a patient level, at a site level, and at a study level. We wanted to see all the available data – not just the data from electronic data capture systems, clinical trial management systems or laboratory systems, but all of the data in a consolidated manner. That would allow people to clearly see what was going on with that patient, that site, or that clinical trial.”
They also wanted to create a platform where trial managers could manage, monitor and mitigate risk within one system – aligning with the concept of risk-based monitoring that was just starting to take off at the time. Remarque aimed to be a provider of solutions for risk-based monitoring of all forms, including remote, central, medical and on-site, in-process analytics, and continuous development for data quality improvement.
“We wanted the system to be able to pull data from multiple sources and expose it to the end-user in a meaningful way,” says Arlotto.
“We also added in the ability to use the TransCelerate Risk Assessment Characterization Tool (RACT). Through that we can manage every possible risk, identify data points that are associated with it, and suggest mitigation strategies when a risk is detected. We wanted users to be able to act on any risks they saw in the system.”
Machine learning algorithms allow a degree of automation and can flag potential issues much earlier in the trial process – and, as pharma has often found out, knowing whether a trial needs to be stopped or altered early on can save companies enormous amounts of money by avoiding drugs that won’t ever make it through the pipeline.
Arlotto notes that there are also more nuanced situations where real-time data can save pharma time and money.
“In studies with complex protocols you can make sure you avoid redundancies. For example, if you only need to give six people the 10-milligram dose, but three sites are recruiting at the same time, you may end up with more patients than you need.
“By having the data come in quickly you can actually start to build in triggers – for example notifying the sites when you’ve dosed enough patients.”
Having a 360-degree view of data like this also means trial managers can see things they might have missed when focusing on a single site.
“Often when visiting a site, you may only look at a limited data set that looks fine – and it’s only when you see the same data from more patients and sites that you start to see a trend.
The company also added a business processing workflow system into the platform – if a user sees an issue in the system, it can be assigned to a named individual to resolve, with the entire process captured in a trial audit for regulatory purposes.
The result is what the founders describe as “the first fully integrated workflow system to design, deploy, and manage clinical trials – one, single integrated solution that connects clinical trial data together, centralising all data sources, without the complexity of using multiple separate components”.
Arlotto and Goodgame say that the advantage to the user is speed of implementation, ease of connecting data together and cost efficiency.
“We think that’s going to be important in the future as clinical trials evolve, and people start to use things like wearables or telemedicine. There needs to be a system that can still consolidate all of that information into one place, and help you act upon it.”
Since its founding, Remarque has been consistently adding new functions to its software, such as dashboarding and business intelligence – as well as the ability to generate monitoring reports directly out of the system, linking those to action item letters that go to a site, and integrating that with an electronic trial master log.
Goodgame notes that many of these innovations, such as dashboards, visualisations and machine learning, are changes that other industries had already embraced.
“We wanted to say to pharma, biotech and device companies that they didn’t have to stick with legacy platforms that were designed 20 years ago and don’t integrate or give visibility on data.”
“We make sure we develop using an agile methodology. That allows us to be very mindful of different customers as they come in. After all, every customer has different approaches, skillsets, and teams.
“We have everything from customers with absolutely no experience in managing a trial through to customers who absolutely lead the way in defining risk-based monitoring methodologies.”
As such, Goodgame says it’s been important to also apply that agile mindset to Remarque’s customer engagement team in order to optimise the customer experience. This is particularly notable with change management, an important area if data literacy upskilling and teams are to be supported to get the most out of the platform.
He says: “The customer engagement team can speak to the company to understand the situation and adapt accordingly. It’s a consultative approach to customer experience. We want to make sure these consultants are highly knowledgeable about how the drug development process works. That knowledge is really important when you’re a small group.”
The company has also added a layer of account management to govern relationships and ensure that the customer gets as much benefit out of the software as possible.
That idea of guiding pharma into the future is a key part of why Arlotto and Goodgame founded the business in the first place.
Goodgame explains: “One of the reasons I joined the life sciences industry in 2003 was that I felt the whole industry had a backwards approach to managing data. I don’t think it was necessarily intentional – but everything used to be done on paper, and when new technology came along it was just used to repeat the same manual processes on a different platform. Most other industries had moved way beyond that.”
He says that the industry is still “a long way behind” on using data.
“But this industry can leverage learnings and approaches that have been honed in other strictly regulated industries and leapfrog ahead. Change is happening a lot quicker than is normal in pharma and I anticipate that things are going to evolve quite drastically in the next couple of years.”
In the meantime, Remarque is keen to show that even a small company can bring great benefits to pharma by staying ahead of the curve in these developments, while giving the industry greater visibility of more types of data, taking an agile approach to development and facilitating risk-based monitoring.
If pharma can embrace these evolutions, then efficient, decentralised and patient-centric trials will no longer be a pipedream, but a core pillar of the industry’s work.
Based in the US, supporting the biopharmaceutical industry globally
17+ sponsors, CROs, and ACROs including large pharma, mid-size pharma and biotech organisations use our platform to support over 100+ trials to date
Real Time Monitoring, RBQM, Dashboard Metrics, Machine Learning. Study Start-Up, CTMS
To provide the industry with the first fully integrated workflow system to design, deploy, and manage clinical trials – one, single integrated solution that connects clinical trial data together, centralising all data sources, without the complexity of using multiple separate components. Remarque Systems improves operational performance of a clinical trial through the following:
Michael Arlotto is president and co-founder of Remarque Systems. Michael is an industry leader who understands the key business drivers to generate value, with more than 25 years of scientific, investment and operational experience in pharmaceutical, biotechnology, pharmaceutical service, and healthcare IT industry.
Joseph Goodgame is the co-founder and chief technology officer of Remarque Systems and has worked extensively in the data and information space for over 20 years. He has been recognised in Computer World for his cutting-edge work on building a patient analysis framework across over 60 million patients, and named on a number of patent applications for new and novel analysis methods.
Kristin Mauri is a director of solution services at Remarque Systems and brings to the role more than 25 years’ experience of clinical research and eClinical technology implementation for pharma, biotech and CRO organisations. She has also presented extensively on clinical operations topics, such as risk-based monitoring, quality management and clinical trial forecasting and budgeting.
Remarque is a clinical trial data company that enables researchers to use data from any source, on one platform. Remarque provides real-time visualizations and risk alerts to study sponsors and contract research organizations (CROs) to enable data-driven decisions.
For further information, visit remarquesystems.com