Swing Therapeutics helps people affected by chronic pain live their best lives through the power of evidence-backed, mobile app-based treatments. The firm’s first prescription digital therapy for the treatment of fibromyalgia symptoms, Stanza, provides Acceptance and Commitment Therapy in a 12-week, self-guided program, with therapies for other conditions set to follow. Stanza is currently offered as a component of care in Swing Care, a telehealth platform providing access to comprehensive, personalized fibromyalgia treatment.
Recently, the company obtained De Novo marketing authorization for Stanza from the U.S. Food and Drug Administration (FDA). This development brings new hope to approximately 10 million U.S. adults who are grappling with the debilitating symptoms of fibromyalgia.
As we reflect on this achievement, it’s essential to recognize the role that Medrio’s CDMS/EDC, eCOA/ePRO, and eConsent solutions played in:
- Facilitating a decentralized approach
- Alleviating pressure on sites
- Championing high-quality and complete data capture
- Successfully demonstrating safety and efficacy to regulators
Making Completely Virtual Participation Possible
In 2021, Swing Therapeutics completed a randomized, controlled pilot trial of Stanza involving 67 participants. The pilot utilized Medrio CDMS/EDC and eCOA/ePRO solutions. This combination allowed for timely data collection and analysis while facilitating an overall positive experience for the site. Due to the ePRO ease of use, SMS notifications, and the bring-your-own-device (BYOD) model, the pilot study achieved 98 percent patient compliance.
Swing Therapeutics needed to remove as many barriers to participation as possible for its subsequent pivotal randomized, controlled trial to replicate this success of the pilot with the demand of an increased scale to support timely regulatory approval.
This challenge meant making completely virtual participation possible, as Swing Therapeutics’ Sr. Clinical Project Manager, Nicolette Vega, reflects,
“Whereas most sites operated a hybrid approach, embracing some decentralized elements alongside traditional in-person visits, the trial’s highest enrolling site was completely remote. With Medrio and its eConsent option, we recruited a significant number of participants, which greatly facilitated the speedy completion of the pivotal trial.
Alongside extending our reach, we also wanted to take the hassle out of participation. Medrio provided a convenient and smooth trial experience for the participants by enabling them to complete weekly PROs from home on their own devices.”
Freeing Up Site Resources, Reducing Human Error
The capability of remote PRO collection demanded significantly fewer resources from the study sites. This increased efficiency was compounded by Medrio’s range of automation features, including SMS notifications and dashboard reports incorporating a traffic light system to flag open queries and support sites to track and manage participant compliance.
An additional benefit was that participants could enter and verify their PRO responses before submitting them, reducing the potential for data transcription errors.
Nicolette explains, “Utilizing direct data entry saved countless hours the study staff would have spent on administering questionnaires and transcribing responses, which eased a big operations burden a traditional site would have. Likewise, because remote PROs were self-reported, monitoring hours were reduced considerably for Swing staff. This feature also removes the chances for human error, promoting the integrity of study data.”
Introducing new technology isn’t always a straightforward process. Technology uptake and impact depend on multiple factors, including participant demographics and site buy-in. Medrio’s user-friendly design helped participants access, understand, and complete PROs independently, while sites derived immediate benefits with minimal training.
The EDC’s test environment was also a useful tool. Nicolette comments, “The ability to do something in real-time is very helpful, and the test environment provided a great platform to train sites to use the EDC through each phase of the participant journey – from [the] screening visit to randomization, through to the last study visit.”
The test environment delivered further value when implementing mid-study changes and assisting sites with queries without compromising blinding protocols.
Promoting high-quality and complete data capture
Being quick to learn and straightforward to use, Medrio ensured Swing Therapeutics could hit the ground running with high-quality and complete data capture. At the same time, Medrio’s automation features boosted real-time visibility and compliance.
Data quality and integrity were vital in supporting FDA approval. Nicolette elaborates, “All study endpoints were generated from remote PRO results, so strict compliance was critical to obtaining complete and accurate data for our FDA submission. Medrio empowered us to take a multi-layered approach to manage this, with email alerts to notify participants when PRO windows opened and daily SMS prompts sent until PROs were completed.”
Medrio’s automated reporting capability, customer support, and overall responsiveness further streamlined processes. Nicolette explains, “We built a custom PRO report that updated daily, providing real-time visibility over open PRO windows opened and closed so that participants could be contacted before they expired. By automating reminders and with the ability to identify and remedy potential issues early with minimal effort, we achieved an impressive 92.6 percent compliance rate, which played an instrumental role in securing Stanza’s FDA approval.”
Nicolette continues: “We’re a small team and needed support along the way. The Medrio team was great to work with and quick to respond, which mitigated delays and contributed to positive site relationships and participant experience.”
When asked what advice she would offer sponsors looking to leverage technology, Nicolette said, “Our compliance rate wasn’t accidental. It was achieved because we decided to embrace automation. Medrio’s built-in automation features empowered us to live and breathe that ethos.
With Medrio, we could sit back and let the tech do its job. That would be my advice to other organizations: take advantage of all the automation options, alleviate the pressure on CRAs – work smarter, not harder.”
