Heart-Valve-Surgery.com, a leading patient advocacy group for patients with heart valve disease, has launched the first phase of an end-to-end digital platform for patient awareness, patient education and patient enrollment specific to clinical trials.
The new platform – which leverages novel algorithms and technologies – was developed to resolve several of the long-established obstacles that plague patient recruitment for heart valve clinical trials.
“During the past 20 years, therapeutic innovations evaluated through clinical trials have transformed the patient experience with less-invasive procedures and shorter recovery cycles,” said Adam Pick, patient advocate and founder of Heart-Valve-Surgery.com. “However, the expense and the time required to enroll patients in a clinical trial can be prohibitive.”
- The median cost to conduct a clinical trial that leads to an approval of a medical device is $94 million on average, according to the Food and Drug Administration.
- Patient awareness to and participation in clinical trials is dismal. A recent survey of 1,157 patients conducted by Heart-Valve-Surgery.com revealed that 73% of heart valve patients are “not very aware” of clinical trials.
- The survey also found that – while only 4% of patients have participated in a heart valve clinical trial – 59% of heart valve patients would consider enrolling in a clinical trial.
“Throughout our focus groups, industry participants referred to patient recruitment for clinical trials as a ‘a nightmare’, ‘miserable’, ‘slow’ and ‘expensive’,” said Pick. “We believe our new platform will address these concerns to help doctors, research centers, medical device companies and, most importantly, patients.”
As a part of Heart-Valve-Surgery.com’s new “Clinical Trials Education Platform,” Abbott, a leading healthcare company and manufacturer of minimally invasive and surgical heart valve repair and replacement devices, has utilized the new platform to help increase patient awareness around several of its research studies including the REPAIR MR and SUMMIT clinical trials. These two trials are evaluating the safety and effectiveness of Abbott’s MitraClip™ Transcatheter Mitral Valve Repair System in moderate surgical risk patients with mitral regurgitation and Abbott’s Tendyne™ Mitral Valve Implantation System for patients needing minimally invasive mitral valve replacement.
“Educating and empowering patients about clinical trials is key in helping them make connections to innovations that could bring them the best care pathways,” said Barathi Sethuraman, divisional vice president of clinical affairs for Abbott’s structural heart business.
The new, patient-centric offering on Heart-Valve-Surgery.com’s website includes educational and interactive resources such as videos featuring the national principal investigators of each research study, downloadable patient brochures, and more.