Eliminating enrolment delays to bring an AI-enabled SaMD to market
Case study
Overview
A medical device developer faced clinical evaluation timeline delays due to under-enrolment. The company was seeking FDA authorisation for a blood pressure monitor device for the detection of supraventricular tachyarrhythmia, atrial fibrillation (AFib), in patients at the time of blood pressure measurement. The study required a sample size of 600 patients, half of whom had AFib and the remaining patients with no known AFib diagnosis. Each patient was required to undergo a 30 minute site visit to validate the device’s sensitivity and ability to measure blood pressure and detect AFib. This software as a medical device (SaMD) solution would use AI and machine learning to analyse the pressure pulse wave during blood pressure measurement. AFib is the leading cause of arrythmia and if untreated can lead to stroke, heart failure, myocardial infarction, kidney disease and dementia. The device was intended for home use by patients carrying out routine blood pressure tests.
Challenge
The study population of 600 patients over the age of 22 was to be composed of specific gender, ethnic and age groups. This complex cohort stratification led to delays in recruiting patients to meet the study requirements. The study timeline was aggressive and coincided with a holiday period. It was further complicated by the geographic locations of key stakeholders with the Sponsor being based in Asia Pacific and the study sites in the US.
Solution
The Sponsor partnered with Accellacare to address the patient enrolment issues. Accellacare Site Network has more than 30 years of experience and access to patients and multi-specialty physicians. Accellacare assessed the study timeline feasibility and developed a targeted enrolment strategy. This strategy identified suitable sites that could deliver the required patients in each demographic within the enrolment timeline. The team tracked the effectiveness of the targeted enrolment strategy, enabling proactive risk management and mitigation to boost enrolment where necessary.
In addition, the ICON Medical Device and Diagnostic Research (MDDR) team led the project management of the study. The team took responsibility for gathering the information and compiling the documentation required for the Sponsor’s FDA submission.
ICON value add
The collaborative partnership between the Sponsor and ICON’s MDDR team steered the study from patient enrolment to FDA submission and approval. Our SaMD clinical validation experience ensured that the study met all regulatory submission requirements within the anticipated timelines. Through our global offices, ICON bridged the geographic and time zone gaps between the Sponsor, clinical trial manager and sites. Strategically located team members delivered effective global clinical operations planning and oversight. Acellacare’s extensive experience of accelerating site startups overcame the earlier delays due to enrolment difficulties prior to ICON’s involvement.
Outcome
The study demonstrated a high rate of both sensitivity and specificity for AFib detection using AI. Based on the results, the FDA granted market clearance. Patients can now purchase the device, allowing them to detect symptoms of AFib at home while monitoring their blood pressure. Patients who detect AFib symptoms can then seek medical support and avoid the potential life limiting effects of untreated AFib.