Whitney Stewart, Director of Clinical Project Management, Shares Insights from Publication with DTA
February 17, 2023
- Whitney gave a brief on the partnership of Curebase with Digital Therapeutics Alliance to provide fit-for-purpose evidence standard for DTx product regulatory, reimbursement, and clinical acceptance
- Whitney also elaborated on the Fit-for-Purpose Evidentiary standards and talked about why the DTx devices do not fit in the standards for medical devices by quoting some examples
- The interview highlights Curebase’s mission to bring quality medical innovations to patients faster to improve human well-being through more efficient clinical studies
Smriti: Thanks for taking the time to talk to us. Firstly, I would like to start with understanding the deal details between Digital Therapeutics Alliance (DTA) and Curebase (financial and commercial details).
Whitney Stewart: Curebase and DTA have a partnership centered around digital therapeutics (DTx) innovation and thought leadership with a shared goal to help DTx organizations conduct effective clinical trials. The partnership is focused on education rather than commercial activities.
For example, in December, the DTA and Curebase released a publication titled, “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard,” which provides evidence-based expectations for how DTx products should be validated by stakeholders globally. The paper outlines foundational principles specific to DTx and baseline expectations for healthcare decision-makers concerning the types, quality, and timing of clinical trials necessary to evaluate and implement DTx therapies in real-world settings.
Our partnership is part of DTA’s Resource Partner Program, which the organization launched to accelerate the development and post-marketing success of clinically evaluated DTx by building a network of commercialization and product development service providers.
Smriti: Can you please elaborate in detail for our readers what is Fit-for-Purpose Evidentiary standards with some examples?
Whitney Stewart: Fit for purpose in this setting suggests an actual system or framework specific to a product type used for evaluation. That doesn’t currently exist for digital therapeutics, but there are existing, well-defined standards for pharmaceuticals and medical devices. In the U.S., the Code of Federal Regulations outlines the requirements for both product types. For example, if you develop a medicine that can treat diabetes and you desire FDA approval, the path is standardized and clearly laid out. You will perform a number of clinical trials of various phases, and the evidence will (hopefully) demonstrate your product is both safe and effective. In this case, the FDA has the framework to evaluate that evidence and confidently provide an outcome. Similarly, insurance companies generally cover approved drugs based on efficacy.
A similar framework exists for medical devices. As part of the process of seeking approval to market, you can either claim it is equivalent to a product already approved or provide safety and efficacy data in hopes of getting approval.
Digital therapeutics are neither pharmaceuticals nor medical devices, so the goal is to create standards for that product type instead of trying to interpret and overlay the framework of different product types.
Smriti: How do Curebase and DTA complement each other in setting standards for DTx?
Whitney Stewart: Curebase is very familiar with the clinical evidence-generation space. We've seen what some digital therapeutics companies have done in terms of designing their protocols and their overall strategies for evidence generation. We've also worked in other product areas: diagnostics, medical devices, pharmaceuticals, etc. Curebase’s experience is in clinical trials and understanding the process of getting drugs or devices approved. For this paper, our contribution focused on the clinical evidence quality section and some of the clinical trial design components.
The DTA and its network of members have vast experience in going through the process of getting approval and communicating directly with regulatory bodies and with payers. The standards created were designed through collaboration with many members of the DTA community.
Smriti: Can you please tell our readers why you think standards for medical devices don’t fit the DTx devices?
Whitney Stewart: When you think of a medical device – a pacemaker, a heart-rate monitor, or pregnancy test may come to mind. To get clearance or approval from the FDA, manufacturers must assess the risk of the device. This means they must either provide evidence it is similar to an already approved device – thus requiring no clinical testing – or perform clinical studies that demonstrate its safety and effectiveness. Devices typically are based on hardware and software, and the components don’t typically change much.
Now, think of some examples of digital therapeutics: a video game to treat children with ADHD, a mobile application to help with insomnia, or a virtual reality program to help with chronic lower back pain. They have a therapeutic intent and generally a lower risk profile. How do you prove those “devices” are safe and effective? In many ways, the process for generating evidence of a DTx is actually more similar to a pharmaceutical than to a medical device. For example, you aren’t proving the video game software can be used to accurately diagnose ADHD. That’s not the claim. Instead, you are trying to prove that using the software helps treat ADHD, similar to the way a drug may. The standards for medical devices just don’t apply to digital therapeutics.
Smriti: Can you please summarize “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard” for our readers?
Whitney Stewart: The guidance offered in the Curebase/DTA joint publication starts by providing sufficient background information on the types of outcomes and endpoints, types of trials, and other general information required to understand the landscape and types of evidence that may be generated for a DTx. This is an important component.
We then go into defining what level of quality should be expected and generated under each clinical outcome domain for the primary stakeholders. Finally, it outlines the phases of development, what types of studies you’ll see at those junctures, and what type of evidence typically is generated in each stage.
Our overall goal with the publication was to provide a foundational understanding of evidence pathways so healthcare decision-makers (regulatory bodies, payers, clinicians, etc.) can appropriately interpret and assess the data DTx companies are submitting and the claims they're making.
Smriti: How does this fit-for-purpose standard guidance help payors, providers, and policymakers?
Whitney Stewart: The guidance is intended for healthcare decision-makers to provide a framework in which they can assess the clinical evidence and feel confident in their ability to determine if it is safe and effective and whether it should be approved, reimbursed, or prescribed. It is challenging to understand when the evidence is sufficient if you are comparing it to the already existing frameworks of pharmaceuticals, medical devices, or even software as medical devices.
Smriti: Is this collaboration working to make DTx assessment standards global or for now U.S. only?
Whitney Stewart: Our joint white paper with DTA was intentionally made regional-agnostic and is intended to apply across the globe. There are some specific references to FDA guidelines where appropriate to provide additional context or helpful information.