Cardiovascular Clinical Trials

Solving the complex challenges of cardiology clinical trials: partnership paves the way

Cardiovascular clinical trials are complex and costly – but combining CRO + DCT expertise unlocks improved patient experience, participant retention, and timelines for sponsors.

Claire Marsden is a Vice President of DCT Solutions, CV/MET at Medable.

MaryAnne Rizk is a Chief Strategy Officer at Medable.

Maria is an Executive Vice President, Decentralized Solutions at Syneos Health.

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Conducting successful studies today is a highly complex and arduous process, requiring deep knowledge and coordination of multiple moving parts. That’s why partnerships are so vital to designing integrated solutions that enable sponsors to optimize their trials.

As the biopharmaceutical industry transitions to decentralized clinical trials (DCTs), the need for coordinated, integrated solutions have never been greater. While sponsors and CROs alike are eager to put the latest technologies to use in improving patient identification, retention, and experience, neither may have the resources to track, implement, and maintain those technologies alone. 

The need for innovative clinical trial solutions is particularly apparent in the cardiovascular (CV) space. With composite score endpoints requiring multiple measurements – including lab and heart function tests, physiological assessments, and time-sensitive data collection – delays are common and patient retention challenging, making CV trials often large and costly. 

By merging CRO infrastructure and clinical trial management know-how with a flexible, innovative DCT platform and expertise, the Medable Partner Network (MPN) enables sponsors to streamline the entire end-to-end CV clinical trial delivery process. For example, Medable’s partnership with Syneos Health®, the only fully integrated biopharmaceutical solutions organization, draws on both companies’ strengths to improve clinical trial efficiency, accuracy, and speed. While Syneos Health® focuses on what they do best—implementing clinical trials—Medable owns the technology side of the equation to solve common problems. These include:

  • Accessing representative populations and reducing screen failure rates: Medable’s data platform offers screening functionality that broadens accessibility and boosts enrollment of more participants that are representative of the target population. Moreover, patients can be screened through local pharmacies, which opens the floodgates of accessibility to trials in both urban and rural settings. 
  • Increasing participant retention rates: As an integrated ecosystem that delivers a connected care experience, the Medable Partner Network enables trial participants to be screened, assessed and receive treatment in their homes through partnerships with home-health nurse services, such as Syneos Health® Illingsworth division, and to receive needed medications or devices via direct-to-patient product shipment and logistics partners.

Both actions save participants from traveling long distances to trial sites, making the prospect of participating and remaining in a study much more appealing. At the same time, CROs benefit from receiving data faster, speeding the entire process. 

In an effort to expand DCT in-home services, researchers are seeking more ways to monitor patients remotely with connected wearable sensors. In CV trials, that means measuring weight (as an indicator of increased fluid retention), blood oxygen levels, and abnormal heart function such as heart rate and atrial fibrillation (AFib). Clinicians receiving these measurements can respond in a timely manner without waiting for a patient to step inside a clinic.

When CROs and Medable partners create a healthcare solution package, many sponsors’ problems are solved. DCT technology and CRO operations excellence can increase patient-to-site ratios, reduce patient screen failure and dropout rates and accelerate drug development cycle times. 

The Medable/Syneos Health®, partnership benefits patients, sponsors, and partners alike by creating a symbiotic relationship that enables the design of innovative DCTs. It’s clear both companies accomplish much more together, pooling their unique expertise to accelerate research into vital new therapies for patients around the world.