The direct-to-subject videos facilitate consistent and high quality pulmonary testing across trial sites
Rochester, N.Y. - iCardiac Technologies, Inc., a leading centralized core laboratory specializing in respiratory and cardiac safety studies, announced today that it has launched a Direct-to-Subject Pre-Coaching video tool to help minimize the variability in respiratory test data caused by differences in subject technique and technician coaching. The training videos will be embedded in equipment iCardiac sends to all trial sites and are brief enough to be shown to subjects at the beginning of each testing visit.
The videos will not replace but rather augment the coaching efforts of the site-based pulmonary technicians. By providing guidance and a clear demonstration to each subject shortly before he or she performs a spirometry test, the videos ensure that each subject hears critical information – explained in a clear and consistent way – about how to successfully complete a test. Further, the videos serve to assist and provide a timely refresher to less experienced site technicians on how to effectively coach subjects.
This video-based training standardization platform, now available in 20 languages, has already been deployed by iCardiac on a major global study.
Spirometry measures lung function, which is the amount of air inhaled and the rate at which it is expelled from the lungs. The accuracy and consistency of spirometry test results rely heavily on the patient’s understanding of how to optimally perform the test, and the knowledge and consistency of the medical professional at the site that is coaching that subject through the test.
While performing this test, subjects often make common errors such as a poor breathing effort, incomplete exhalation, or improper use of the equipment. Consistent and effective spirometry testing are critical to the overall outcome and reliability of a clinical trial.
“From the over 250 respiratory clinical trials that we have performed, it is clear that a leading source of test data variability is the variation of coaching styles and knowledge among medical technicians at different clinical sites,” said John Sage, Senior Vice President of Respiratory & eCOA at iCardiac Technologies. “This tool directly and effectively addresses this common issue.”
“We drew upon principles from the fields of cognitive learning, technology-enhanced instruction and psychology to develop this simple but powerful solution,” said Alex Zapesochny, President & CEO of iCardiac Technologies. “And it is being embraced not only by sponsors but also by many site technicians and study subjects for simplifying and improving the overall clinical trial experience.”
About iCardiac Technologies
iCardiac Technologies, Inc. is an industry-leading centralized core laboratory for respiratory and cardiac safety testing services. It has conducted some of the industry’s largest global respiratory studies and has a history of driving innovation across cardiac safety and pulmonary testing. The company serves 8 of the top 10 global pharmaceutical companies, as well as numerous small and mid-sized pharma and biotechnology firms. For more information, please visit: www.icardiac.com.
Empowering Sites and Patients: The Impact of Personalized Support in Clinical Trials
November 26th 2024To meet the growing demands of clinical research, sponsors must prioritize comprehensive support models, such as clinical site ambassadors and patient journey coordinators, who can address operational challenges and improve site relationships, patient satisfaction, and overall trial efficiency.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
FDA Finalizes Decentralized Clinical Trial Guidance
November 25th 2024The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.