DTx company leverages Castor’s Real-World Evidence platform in Registry study

Introduction

It’s well established that when patients go looking for support, not everyone wants to go down the medications route. This can be due to potential adverse side effects or simply personal preference. Enter a digital therapeutic company at the forefront of innovative behavioral disorder research. The company is committed to challenging the status quo and believes in the importance of alternatives to medicinal treatment. 

In order to assess real-world clinical outcomes of patients using their digital products, the company ran a registry study, using Castor’s eClinical technology. The objective of the prospective product registry study was to better understand the clinical and demographic characteristics, treatment patterns, clinical and quality of life outcomes, and healthcare utilization in users in real-world settings. All study activities were conducted fully online and were sent to participants in a direct-to-participant model.

The Challenges of Conducting a Direct-to-Participant Registry Study with a Small Clinical Team

In fitting with the digital nature of their products, the team sought to operationalize the study efficiently, cost-effectively, and fully remotely. However, conducting a siteless study with a direct-to-participant approach brings certain challenges:

1. Participants from all 50 states could partake in this study, thus leading to a need for easy-to-use, remote technologies that allowed for a diverse population set to access and use them in adherence to study protocol.
2. As a longer-term registry study, they needed a platform that could securely handle large amounts of data.
3. With a small clinical team, they needed a tool that would cut out manual work and save time, for example, by scheduling surveys, and by not having to switch between multiple systems.
   

As with all groundbreaking healthcare-focused technologies, challenges also exist in communicating the solution in a meaningful and patient-centric way to the target audience. The benefit to the company of running a registry study like this, with Castor, is that it provides the hard data to make proven claims about the product’s effectiveness. A successful study can provide social proof to help promote the product.

With these challenges and goals in mind, this digital therapeutics company chose Castor as their first-choice solution.

• Industry

  Digital Health/Therapeutics

• Challenge

  In conducting a fully remote, direct-to-participant registry study, the DTx company’s challenges included managing participation from a diverse demographic across all 50 states, securely handling large volumes of data, and minimizing manual tasks for a small clinical team.

• Solution

  Utilize Castor’s secure platform for real-world evidence, integrating eConsent, electronic data capture (EDC), and electronic patient-patient reported outcomes (ePRO) in one system to reduce their manual work, ensure data integrity and enhance the participant experience.

• Result

  The Castor solution was effective with the registry study providing concrete real-world evidence, enabling the company to validate treatment effects and support potential regulatory submissions. The data from the study also bolstered marketing strategies by demonstrating benefits to participants with certified claims.

The goal for the study included measuring treatment outcomes in order to get a bigger picture around the different ways that their product could be helping patients. To do so, the team incorporated a variety of assessments into the registry, including behavioral disorder-specific assessments, quality of life assessments, and a healthcare utilization survey. Due to having a small clinical team, they needed a tool to cut out manual work while withstanding the vast amounts of data being collected. Castor ePRO was able to fill that need by delivering multiple assessments and questionnaires to study participants through a single survey link that could be easily accessed.

Thanks to the smooth transition from eConsent to data capture, plus the ability to schedule surveys and reminders, the company’s Clinical Research Manager was able to save time in their busy schedule: “From a research manager or a coordinator’s perspective, Castor’s platform saves a lot of time, approx. 1-2 hours a day, which is a huge benefit when you’re a part of a small research team.”

Castor features the client loved:

• ePRO Compliance Dashboard for maintaining compliance & data integrity
• User roles/permissions for team visibility
• EDC Study Progress Dashboard for real-time insights
• Signed consent forms download with attached participant screening IDs for ensuring files are correctly labeled and kept

For building out the study, the team used a combination of Castor’s self-service technology and Castor Professional Services offerings. The study recruitment and landing page, CDMS, and integrations were built out by Castor’s experts in just 6 weeks. The team did a self-build for eConsent, which they found a simple process with all the configuration fields available for them, allowing for the clinical operations team to build out eConsent in only a day or two. With the help of Castor’s support and customer success teams, plus the free Castor Academy training materials, any questions about the build were quickly addressed and answered.

Result: Real-World Evidence for Combating the Effects of a Behavioral Disorder

Here’s how the real-world evidence gathered with the help of Castor is supporting the company’s study goals:

Traditional clinical trials can prove very expensive and non-reflective of real-world patient populations. This registry study provides the company with concrete real-world evidence to further study and conclude treatment effects. They also can potentially use this data for regulatory approval submissions.

The study provides Castor’s client with supplemental data for marketing efforts. Based on such data, they may be able to promote, for example, that X percentage of participants using their product in the real world saw Y particular benefits and improvements. Additionally, they can use this registry as a motivator for the current participants as well as prospective users:

• It encourages current participants by providing them scientific information on what they contribute to, which in turn gives them a cause – helping others with behavioral disorders in the future.
• It influences prospective users’ decisions of whether or not to try the product. As a registry study with participant payments involved, some may be financially motivated, some encouraged by being able to contribute to science, and others by curiosity and to better their conditions.

Finally, the study benefits the participants themselves – they are curious about how they’re doing, and want a way to measure their progress with the treatment. And so, being able to generate the data to give back to participants is a goal now being fulfilled. The registry provided the company with real-world data to start investigating some of the questions that the product users and their healthcare providers have had about the treatments, such as long-term effects, and whether users should be on or off of medication at the same time of treatment.

Conclusion

Castor’s client needed an efficient, easy-to-use, multi-functional tool to run their registry study for their treatment of patients with a behavioral disorder. Castor’s eClinical system, including eConsent, EDC, and ePRO, helped the team to collect Real-World Evidence (RWE) to support product research and claims. This collaboration contributed to the success of the study and provided evidence that may ultimately support a higher quality of life for those all over the world with this behavioral disorder.