Three Questions: Thaddeus Wolfram, Ernst & Young
CWWeekly today is launching a new occasional Q&A feature, Three Questions, interviewing executives in the clinical trials space. Staff Writer Ronald Rosenberg sat down with Thaddeus Wolfram, senior manager in Ernst & Young’s Life Science Advisory Practice.
Q: You have written that wearables offer an opportunity to flip clinical trial design and protocols on their heads, leading to a complete rethinking about what clinical trials look like. Please explain some of those promising changes.
A: First, different aspects of clinical trials will be changed through wearables. There will be more access to the right patients. The site is no longer a physical site but, rather, a virtual or remote one. The new opportunity is to reach out to geographies further away from traditional clinical sites.
You’ll also be able to look at a greater range of differences. When you look at comparative therapies, you can look across a broader swath of available information around these patients through wearables, allowing a greater range of insights around the differences in responses in safety and efficacy compared to current therapies.
The flipping part, when you think about today, is the clinical trial design and specifying that 80% to 100% of the data collected from the trial will be relevant. What will happen with the breadth of information available through wearables is that you may be specifying only 20% of the data you need to reach your endpoints. But in reality, you are going to reach into that world of data now available through wearables and what comes out represents the last 80% of the data required.
You really have to rethink the way you design trials with regard to how you will capture and analyze data and apply them to your endpoints, while also maintaining consistency—all within the study timelines.
Q: You have stated that regulatory clarity on the use of wearables in clinical trials may take many years to evolve. What are the key issues that must be addressed?
A: One of the biggest challenges to moving wearables forward is consistency. It is getting clarity within a trial, to ask: What level of variability might be acceptable? How do we control or mitigate for too much variability in the data? How do we validate what we are going to use or need to throw out and how do you get agreement from regulators? The consistency of the information coming in is one of the major hurdles.
Often, when new technologies and new approaches come up, the FDA and regulators elsewhere work through various draft guidances on how things will be managed. It tends to take quite a bit of trial and error and additional knowledge capture before things are solidified. Based on historical data, my assumption is that these changes will take several years to evolve. However, the pieces that need to fall into place to get more comfortable with wearables in clinical trials start with general agreements across industry and with regulators around what data will be acceptable as primary and secondary endpoints. It is getting back to the consistency and what the data look like. What parameters around a device make it acceptable to collect patient data? What validation will be required for a wearable device to take part in a clinical trial?
You definitely can leverage what exists today with regard to monitoring and testing devices in clinical trials. But now you have to ask, what is the level of validation on these wearable devices? What data are going to be acceptable for endpoints, and how do we agree on the levels of consistency and variability? What limitations are allowed so regulators will accept the information to move forward beyond the trial?
To reduce ambiguities, it’s an agreement on what data are acceptable as primary and secondary endpoints, along with the acceptable parameters of the devices. What validation is needed on the wearables so they become acceptable data collection devices?
Q: While today’s devices essentially are consumer ideas for mobile health, what is needed for a new generation of wearables to address the needs of clinical trials and help streamline the process?
A: Since there is significant ambiguity, and greater regulatory guidance obviously is going to help move things along, there is a need to move away from the consumer focus of mobile health and put a real focus on collecting relevant clinical trial information. This means technology development to collect the right data along with some very forward-thinking capabilities, such as monitoring of microbes in the blood stream in real time. It’s about determining the right data to be collected and how technology can be developed to do that.
The technology needs to limit or reduce the number of deviations from the standard protocol. This gets back to the consistency issue. How do you limit deviations from the trial protocol and/or how do you try and enable the device to alert the investigators when a deviation has occurred?
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This article was reprinted from Volume 19, Issue 20, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »