Real-world evidence group NESTcc is at “a pivot point,” says Sandra Siami, who began heading the center this month.
While the moniker real-world evidence (RWE) is relatively recent, she said, the industry has for decades considered the category, defined by FDA as clinical evidence derived from a variety of real-world data sources about use and potential benefits and risks of a medical product.
For Siami, the move to the National Evaluation System for health Technology Coordinating Center is the latest step in a career building research expertise on medical devices. She most recently oversaw Anthem subsidiary Healthcore's clinical research business unit, whose work includes planning and executing a variety of clinical trials, postapproval studies and registries.
FDA supported establishment of NESTcc by the Medical Device Innovation Consortium to build a dedicated hub in the medical device and health tech industries that generates RWE across medical devices' total product lifecycle for purposes of regulatory and clinical decision-making.
The center has been running so-called test cases with a mix of public and private backing as a proof of concept for NEST's value to the industry. Its sales pitch as it grows is its ability to generate evidence pre- and post-market, including to support marketing submissions or labeling expansions. It's also aiming to soon offer active surveillance services.
Prior to Siami's joining the center, much of NESTcc's focus was on building its infrastructure and network. But in the coming months, NESTcc expects to share updates on its test cases, financial sustainability efforts, active surveillance work, and expanding its global reach.
This interview has been edited for clarity and brevity.
During your time in the industry, how has perception of real-world evidence evolved?
At first, real-world evidence was ‘let’s do registries,’ and that was what we considered real-world evidence. And then we had claims data and that became real-world evidence. And now our possibilities are so immense of what kind of real-world data is out there to be able to then generate the evidence that we need for clinical decision-making, regulatory decision-making, and even reimbursement decision-making.
How has COVID-19 affected the space?
Certainly with COVID, that’s kind of upended clinical research. We've had to find different ways of continuing to get the data that we need for these studies and relied more on real-world data.
If there's any sort of silver lining to be had with this, it’s that real-world data and real-world evidence generation has now come into the limelight. And we are seeing more and more adoption and acceleration of the adoption ... The interest is there in doing more real-world studies.
What barriers still exist with getting everyone on board with this type of research?
There might be some companies who are risk averse or may not want to be the first ones out of the gate to test something.
I think once we are able to release our results of completed cases, then that is the litmus test of success, if we're successfully able to complete those. And so you'll be seeing over the next few months our release of completed cases.
What do you mean when you say NEST is at ‘a pivot point’?
First and foremost, we're at a pivot point in being able to demonstrate success. Having successfully [implemented and completed] test cases, we are now at a point to share those results and show our success in utilizing various types of real-world data that are being provided by various types of network collaborators for the medical device lifecycle.
The other pivot points are around our capabilities and initiatives that we are continuing to build out. So for example: active surveillance. We are working on our active surveillance activities which ... is very similar to the FDA Sentinel initiative for drugs. So our active surveillance is for devices and we recently put out a call for working group members for that, for experts for that methodology.
We also have to think about our infrastructure, how are we going to use data. What's the cloud infrastructure going to look like? What are those controls going to look like?
To be recognized as an FDA collaborative community is another pivot point because this is going to be, if I can use the word again, a community where stakeholders are going to be able to have discussions about what's of interest to them to help move things forward ... we have so many possibilities with the data that we have access to and how it can be used.
How does the business acumen you've built in past roles play into financial sustainability goals at NESTcc?
Sustainability is all about making sure we have, for lack of a better word, a product that is of interest to industry and of value to our stakeholders.
Whether it's industry, meaning medical device firms or health technology firms, or even having potential clients be payers, both public and private, or even patient-level advocacy groups that might want to use that real-world evidence. Societies and clinicians are using the data for clinical decision-making. It's all about catalyzing the use of real-world evidence and improving on patient outcomes. As long as we continue to meet those needs, we're going to continue to be successful in that model.
Where do you hope NESTcc will be a year from now?
I think we're going to have higher visibility within industry; and by industry, I'm not limiting that to medical device and health technology companies, I'm considering industry to be our entire stakeholder spectrum.
Folks will know NEST, it will roll more off the tongue because we will have been able to release results and be a proven entity and initiative.
Certainly active surveillance has a lot of interest already from our stakeholders and from our community. The collaborative community is of interest for researchers, for those folks who want to talk through more what is of interest to them, which may or may not lead to a particular study; but it is a forum for having those conversations.
Just to put it into perspective, part of our growth plan and our business plan is we are looking to double our size within the next six months, and beyond that we're looking to continue to increase our size — we're looking to grow substantially, and so with that comes more visibility.