Expanding Innovative and Inclusive Medicine Through Clinical Trials

Aida Causevic-Mendelson
August 3, 2023

Over the past three years, the clinical trial team at Carbon Health has made significant contributions to vaccine, drug, diagnostic, and medical device innovation. Thanks to Carbon Health’s Connective Care model (an omnichannel approach), trials can reach patients across 120+ in-person clinics, as well as home-based and virtual care. This range of access points provides trials with a large, diverse patient pool and geographic reach that can reflect the general population’s rapidly evolving healthcare needs. 

Bringing together tech, operations, and care delivery 

Because Carbon Health is a full-stack healthcare service, our technology and provider care work together to find the most relevant patients for studies. This means faster and more diverse recruitment, all enabled through vertical integration. As a result, we have broadened trial access to an additional one million patients across the country, including many who have never participated in a clinical study before. 

A pandemic launching pad

Our clinical trial program has humble beginnings. During the pandemic in late 2020, we partnered with a COVID-focused startup to recruit patients for their study using our homegrown EHR, an experienced clinical trial leadership team, and tightly integrated operations. We hypothesized patients would be more willing to participate in a trial conducted by their trusted provider in a familiar care setting. 

The result? We recruited 100 patients within a month — which is a staggering amount considering clinical trials can often struggle with recruitment, sometimes failing to bring on even a single patient. Because of our reach as a community provider, we can market studies broadly to patients and activate them through both digital channels and across locations.  

COVID-19 was a watershed event requiring surer and faster results to impact the lives of millions of people. It proved that clinical trials can move expeditiously to get important therapies to market sooner. For Carbon Health, it was a catalyst toward a new service line where patients and providers could have a broader impact, as more providers could now have the chance to work on trials. We have also witnessed trial expansion into a range of acute and longitudinal general medicine conditions.

Rapid patient recruitment through data and technology 

We typically recruit the first patient within a week of outreach. Our team reaches out to relevant patients based on EHR data that shows they fit inclusion/exclusion criteria. We’re continuing to innovate here — making the process of identifying eligible patients easier for our providers with built-in flags in the EHR. Following the patient/provider conversation, patients are more likely to engage in follow-up conversations about trials (compared to randomly getting an e-mail about participating in an irrelevant study). In fact, our email campaigns consistently achieve 65% plus open rates.   

As a result, we have never failed to recruit patients for a trial, and we outperform our patient recruitment targets in a majority of our studies.

Making research more representative and impactful

Clinical trials were traditionally conducted at academic medical centers, or by well-known principal investigators in standalone research centers, working within a known patient population. These institutions are not always accessible to the general population. This is changing. A wider variety of organizations are participating in study conduct, from decentralized clinical trial companies (DCTs) to retail pharmacy chains, and now Carbon Health.

With its mission to provide accessible healthcare, Carbon Health’s clinical trial enrollment reflects the diverse communities we serve. 39% of trial participants at Carbon Health to date come from underrepresented backgrounds, considerably higher than the average reported by the FDA in 2022. We’re continuing work to increase this number.

1 - Cumulative data on trials conducted to date, including active studies with closed enrollment. Includes randomized and enrolled (screened) but not randomized participants

Every provider can be a clinical researcher 

Clinical research can often feel like an area where a provider has to be born with experience. At Carbon Health, we’re changing that by embedding research into routine clinical care settings.

While we bring clinical trials to the “bedside” for more access for providers, we also ensure safety, regulatory, and quality requirements are met. Our program is orchestrated by an experienced Central Research team who have conducted hundreds of research studies in a variety of therapeutic areas (TAs).  

This Central Research team has several functions. First, it serves as a single point of contact for sponsors and CROs, and due to their extensive experience can ensure a < 1-month typical study start-up including a single streamlined contract, budgeting, and onboarding process regardless of the number of regions we bring online for a trial. It also plays a pivotal role in the initial pre-screening and patient recruitment. 

Second, they’re responsible for research-specific tasks, in close collaboration with the local site PI, coordinators, and staff, such as data collection, QA/QC, and sponsor communication. In our completed trials we have had fewer than 0.3 important protocol deviations per subject. We have a 90% under 14-day form completion rate and an 80% 5-day query answer rate.

Third, the team trains site clinicians and staff to allow local staff to conduct the patient visits within a trial with careful oversight and support from the research team. This model allows us to scale the program across our locations in a lightweight fashion and gives our staff exceptional professional development opportunities. Providing novel care options to patients is gratifying for our frontline clinicians and one of the reasons many of them became clinicians in the first place.

The future of clinical research at Carbon Health

By sharing our model and an effective and safe framework, we hope to encourage other community-based care providers to participate in clinical research.

In the last few years, our focus has been on standing up a high-quality program that generates value for patients, sponsors, and staff. We’ve gained the trust of the industry by excelling in trials across varied disease states and therapeutic modalities. 

We aspire to partner with sponsors in multiple geographies while providing the participant and geographic diversity required to successfully bring a drug to market.

We’re on the lookout for equally ambitious and innovative industry partners and would love to hear from you. To learn more, reach out to us at clinicalresearch@carbonhealth.com.

Aida Causevic-Mendelson

Aida Causevic-Mendelson has led strategic growth, partnerships and business development in healthcare and technology organizations for over 20 years. At Carbon Health, she oversees the incubation and growth of new service lines, spanning clinical research, enterprise services and public health.