CLINICAL RESEARCH TRENDS CHANGING THE INDUSTRY IN 2020 & BEYOND

 

Trial Better host and ERT’s Director of Operational Readiness, Jason Eger, is joined by a number of ERT experts for a discussion reflecting on industry trends in 2019, and looking ahead to the clinical research trends we anticipate in 2020 and beyond. See below for episodes on Cardiac Safety, eCOA, Imaging, Respiratory & the future of Digital Patient.

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Clinical Research Cardiac Safety


The State of Cardiac Safety in Clinical Research – 2020 & Beyond


What have you seen and experienced in cardiac safety in 2019?

Cardiac safety is typically seen as a very stable area. However, in 2019, there was a lot of evolution as sponsors began to look for ways to reduce patient burden and find real-world cardiac evidence. Enter wearables: advancements in these convenient devices have made it possible to track patients’ health and the safety and efficacy of therapies at home, as in Stanford Medicine’s Apple Heart Study. This trend also reflects the shift toward home-based monitoring, which was reflected in the FDA’s new guidance on ABPM.

What do you anticipate happening in the industry in 2020 and beyond?

It’s become clear that passive health monitoring is the future of clinical trials. Technology will allow sponsors to collect data while the patient goes about their everyday lives, without requiring them to remember to wear or charge a device, even one they already use. Advancements in science and technology are making it possible to monitor patient health at home in ways that are increasingly less intrusive, deviceless, and home-based. These developments will continue beyond 2020. In the next year, we also anticipate a huge shift toward virtual trials and the evolution of wearables as they become less exploratory and instead primary and secondary endpoints in clinical trials.


THE STATE OF eCOA IN CLINICAL RESEARCH – 2020 & Beyond


What trends have you seen in eCOA in 2019?

Although BYOD isn’t a new idea, the perspectives on it are evolving industry-wide. In the case of ERT, we typically provision devices but are leading the way by providing multiple avenues to collect patient-reported outcomes, including provisioned devices, web portals, and cell phone apps on the patient’s own devices. It’s clear that this method of data collection is now acceptable in the industry. The most interesting aspect is a new trend of multi-modal data collection. This presents some new challenges, but the industry is poised to overcome them and ultimately making it easier for patients to participate in clinical trials.

What do you think the future looks like?

Although BYOD isn’t a new idea, the perspectives on it are evolving industry-wide. In the case of ERT, we typically provision devices but are leading the way by providing multiple avenues to collect patient-reported outcomes, including provisioned devices, web portals, and cell phone apps on the patient’s own devices. It’s clear that this method of data collection is now acceptable in the industry. The most interesting aspect is a new trend of multi-modal data collection. This presents some new challenges, but the industry is poised to overcome them and ultimately making it easier for patients to participate in clinical trials.


Imaging Clinical Research


The State Of imaging In Clinical Research – 2020 & Beyond


What trends have you seen in imaging in 2019?

One of the biggest trends has been an increase in demand for imaging over the last year as more and more trials have begun to require imaging as a primary endpoint. This has always been common in oncology studies in particular, but not the industry is starting to use imaging as a primary endpoint in other indications as well.

What do you think the future looks like?

In 2020 and beyond, there will be a push toward siteless trials. In imaging, we may be able to use subjects who live far from a primary site and previously would have had to travel for imaging. They’ll be able to visit a local center for imaging instead, and have those images uploaded remotely to a platform for centralized assessment. In fact, ERT’s platform allows this already: sites and local centers are able to complete uploads.

How has artificial intelligence had an impact on imaging?

We can use artificial intelligence to determine whether or not an image is appropriate. By using the information we’ve gathered over the past 15 years, we’ve trained an AI algorithm to determine the quality of an image. AI can also pre-segment images and so readers don’t define boundaries within the image themselves. This reduces variability and gives sponsors additional information that they may not have gotten from simplified criteria. Artificial intelligence can be used to improve efficiency and cost, and also maximizes the data being collected, which is particularly important when a patient is being exposed to radiation during the imaging process.

Clinical Research Respiratory


The State of Respiratory in Clinical Research – 2020 & Beyond


What trends have you seen in respiratory in 2019?

In previous years, there were a number of blockbuster drugs developed for conditions like asthma and COPD. However, these drugs are beginning to move off-patent, so the industry is beginning to see studies for generics taking place. Because these blockbuster drugs are still on the market, sponsors are instead looking for new indications to apply these treatments to, where they might achieve small benefits. In order to find these incremental effects, the size of the study must increase. However, respiratory trials are not immune from the industry-wide patient recruitment issue. Additionally, these new products are fairly niche and respond to a small subset of patients; as drug companies are testing a lot of the same mechanisms, this leads to more competition for an already small patient population. The shift in clinical research towards personalized medicine continues to exacerbate the problem. Finally, this new search for small treatment effects requires very accurate data.

What do you anticipate respiratory drug development looks like in 2020 and beyond?

The key change is going to be a stronger focus on data quality and the importance of understanding exactly how the drug works in every individual patient. In order to do this, the challenge of data variability needs to be addressed by a shift towards research-grade quality lung function testing. This will allow the data to reflect small treatment effects. The updated ATS/ERS guidance published in October 2019 recognizes the importance of reducing data variability.

How does this new guidance and focus on reducing data variability affect the industry in general?

High quality data often comes with a higher cost but the potential rewards are huge, because data variability has an impact on every phase of development and can compromise decision-making and revenue potential. We’ve learned that the results of a trial can be undermined even if only 10% of the data is corrupt.


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