Join the Mednet team as we celebrate the 57th Anniversary of American Heart Month.
The first American Hearth Month was established in 1964 following a proclamation by Lyndon B. Johnson. In announcing the first heart month, President Johnson stated, “I urge the people of the United States to give heed to the nationwide problem of the heart and blood-vessel diseases, and to support the programs required to bring about its solution.”
More than a half a century later, heart health continues to be a top priority for researchers, public health professionals, health care providers and clinical trial volunteers. Heart disease is still the leading cause of death for both men and women in the United States. In fact, cardiovascular disease is the leading cause of death globally and is expected to rise.1
These statistics highlight the importance of research in the cardiovascular arena. A recent search on clinicaltrials.gov resulted in over 2,100 active clinical trials for cardiovascular diseases.2 However, research in this therapeutic area has its own set of challenges. Often, cardiovascular trials are event driven and this means that they can take years to enroll patients. Because of the length of the study, retention is also a challenge. Clinical researchers often must re-organize their teams to support continued engagement of trial participants over longer trial durations. Enrollment and retention require significant focus throughout the conduct of the trial.
Cardiovascular trials also typically require extensive and complex adverse event collection processes. In the world of electronic data capture, these processes require a separate event form for each type of adverse event (stroke, bleeding, myocardial infarction, etc.). A particular adverse event type will also have extensive Clinical Endpoint Committee (CEC) forms associated with it. At an operational level, the event type must trigger a specific event form that is related to the adverse event.
Within iMednet, adverse event forms can be collected with an identifiable event type, which triggers the specific event form. This automated process saves time but also reduces error rates, providing better data quality. Our flexible approach also supports the use of key words in adverse event forms as automated process triggers. Patient type reports displayed on a patient record page help to tell the story for each trial participant.
Cardiovascular study designs also often require collection of detailed information about specific blood vessels, lesions or devices, depending on the type of study. iMednet’s flexible form design enables users to create embedded logs within the CRF to capture this detailed information.
iMednet customers have used the platform to support hundreds of cardiovascular trials. These trials include all study phases for medical device, pharmaceutical and biotech research teams and their CRO partners. In fact, the cardiovascular therapeutic category is the most widely researched on the iMednet platform to date.
Many of our customers continue to research new and innovative ways to advance the care and treatment of heart and vascular diseases. They rely on innovative and flexible solutions that support complex trial designs and automate critical information collection, management, and tracking during the conduct of the trial. Essential automation improves clinical research and helps teams make decisions and conduct analyses based on higher quality data, that is more rapidly available for assessment.
As our customers continue the important work of cardiovascular research, we commend them during American Heart Month. We acknowledge their efforts toward driving innovation in cardiovascular treatments and improving the quality of care and health outcomes for people living with heart disease.
To learn more about how Mednet’s flexible platform or our experience in cardiovascular studies, contact us.
[1] https://www.heart.org/en/about-us/heart-and-stroke-association-statistics?uid=1740
[2] Clinicaltrials.gov search for active trials, cardiovascular disease, accessed February 15, 2021