For years, variants of Risk-Based Monitoring (RBM) have been implemented within sponsor organizations to carry out their data management activities. With all the rage these days centered on how innovative technologies can disrupt study processes, questions are abound as to what impact that will have on the way companies collect patient data.

In the case of RBM in particular, with machine learning and AI coming to the fore, will the industry need a rethink on how it identifies risk in clinical trials?

In this Industry Viewpoint, CTA Editor Henry Kerali sits down with Dr Craig Elliott, who’s the Global Head of Operations at Clintec International. An expert on technological advancements, Elliott explains why the industry needs to hit the reset button on RBM and adopt what he calls a ‘data-driven’ approach.

Henry Kerali: Define the concept of Data-Driven Monitoring and why RBM should instead be classed as such?

Dr Craig Elliott: RBM can mean a lot of different things to different companies. Despite ongoing efforts for standardization, RBM can comprise of Targeted Monitoring, reduced Source Data Verification, Remote Monitoring, Centralized Monitoring, and all points in between. In practice, RBM focuses on those data points and data processes that are important to the outcome of a clinical trial. However, risk within the pharmaceutical industry can be seen negatively.

While the ICH E6 R2 revision tried to use ‘risk’ in a more positive way, in my experience at Clintec when dealing with biotech companies and smaller pharma organizations, they are not always prepared to take a risk on RBM approaches because they see this as something that may not work effectively for them. Whereas, when Clintec are working with sponsors we state, ‘we’re going to use a data-driven approach,’ and as part of that we will review the consent forms, the safety parameters and the major outcomes, they feel confident the important pieces of information are being dealt with correctly and properly. This is Clintec’s approach to monitoring.

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When writing the protocol, Clintec work closely with sponsors to define the data points to drive the monitoring. So instead of having a rigid monitoring plan, whereby a team reviews the data centrally and makes decisions, a flexible monitoring plan enables onsite monitoring to occur as and when the critical data points are achieved and reached.

HK: Is there a need for industry to recalibrate its mindset towards RBM?

CE: Yes, especially with the use of technologies that are available now, in terms of electronic data capture systems and clinical trial management systems. In order to ‘derisk’ RBM, it’s essential to take out all implications of risk. The rationale behind RBM is to identify those areas that may have the greatest impact on patient safety, the critical endpoints, and the data. None of those are ‘risk’ per se, they are aspects that can inform clinical protocols, monitoring plans and safety plans.

HK: How can a data-driven approach facilitate better patient recruitment and retention?

CE: By focusing on the important data, you actually take away a lot of the extraneous data that we collect and have always collected in clinical trials. When making a submission, a large percentage of the data is tabulated; it’s never analyzed. Very little of the data collected in the clinical trial is actually analyzed – only the data that is analyzed is important data.

By using a data-driven approach, Clintec can help sponsors write protocols that focus only on the data that is absolutely necessary and in so doing, reduce the burden placed on the sites, and most of all the patients. If you’re reducing the burden on the sites, they are more likely to prioritize your trial over other studies that may involve more work on their part. If you reduce the burden on patients, they are more likely to be retained and complete the trial with improved compliance. As a result, sponsors are more likely to have better quality data, quicker recruitment and faster study timelines.

But make no mistake, a data-driven approach will never work with a poorly written or a poorly conceived protocol. You cannot get away from the fact that you’ve got to get the fundamentals right – the endpoints have to be achievable and the patient population has to be realistic. In a data-driven environment, it’s vital to incorporate patient-centricity into the protocol.

HK: Do you feel the recent ICH E6 R2 addendum enables trial sponsors to adopt a data-driven approach?

CE: Personally, yes I do. I think the addendum is encouraging the industry to focus on important, critical data rather than on areas of little value that have historically taken up a lot of the time involved in a clinical trial.

HK: Where do you see RBM moving forward in the next decade, bearing in mind the potential impact machine learning and AI can have on the way data is generated?

CE: I started in the industry a long time ago, and if you considered then the idea of not using paper as the basis for conducting a clinical trial, you’d have been seen as mad. We have reached a point where now it’s possible to conduct a paperless clinical trial. What’s more, historically, if a pharmaceutical company had a drug that had come off its preclinical activities and into Early Phase I, the first thing they would do is map out a clinical development plan. The way technology has disrupted clinical trials means companies aren’t able to determine what it will be doing with the molecule in five years’ time.

There are medical grade technologies available that allow people to measure their heartrate, blood pressure, respiratory function – such devices can be used to generate data, and that data can be downloaded automatically, effectively taking the risk out of clinical trials entirely. In four to five years’ time, so much of the clinical data will be collected at the patient’s home without the need for them to come in and visit a physician, which is an enticing thought.

HK: How will this affect the way trial sponsors look to outsource their RBM activities?

CE: Large sponsor companies must embrace the technological advances that are occurring with wearable devices in telemedicine. How they are leveraged within a clinical trial setting will be at the forefront of clinical research. Obviously, before they can be used, the technologies must be approved by the authorities.

When that happens, sponsors will start to have their own software divisions or work closely with software developers to ensure they have validated systems in place for data collection purposes in a clinical trial. Ultimately, that will be the panacea for a data-driven clinical trial. However, small pharma or biotech companies will look to CROs such as Clintec that have embraced the use of technology and can facilitate the use of appropriate technologies within clinical trials and support sponsors to achieve the outcomes of their studies.

Consequently, sponsors will have to work with multiple vendors in clinical trials. CROs themselves will have to become technologically-driven, and work with multiple sponsors and vendors while having eClinical systems that collate data from a number of providers. The days of having in-house growth and developing your own systems will be very difficult to continue because you won’t be able to develop a single in-house system that can cope with all the disruptive technologies that are being developed.