Our client needed high enrollment within a short time period for a general-population research study to measure serum leptin concentrations in obese individuals.
The primary objective of the non-interventional study was to measure fasting leptin levels in a large population of obese individuals (defined by a high BMI of a specified range). The projected enrollment was greater than 10,000 subjects within six months. The client was also searching for retention of subjects who would be targets for enrollment to participate in an interventional phase of the study.
Life Line Screening developed and implemented an innovative approach focused on face-to-face education at local screening events.
Patients who responded to the outreach program were screened at one of 17 Life Line Screening's mobile screening clinics. After completing the ICF and meeting all inclusion/exclusion criteria, subjects with a high BMI of a specified range enrolled into the trial.
In addition to providing screenings, LLS developed and executed a sponsor-approved eConsent process for the study. Within 60 days, the study protocol was implemented at all sites so that blood samples could be collected. LLS personnel involved with the study also became IATA Certified to meet compliance requirements for shipping biomaterials with dry ice.
Life Line Screening began by leveraging our industry experience and trust built with our participant population. These valuable patient relationships ensured a consistent flow of high-quality screenings right out of the gate.
Life Line Screening's customized program and strategic efforts generated a total of 10,891 eligible participants, with 5,712 patients screened and enrolled into the study over a period of four months. By working with LLS, the trial's deadlines were met ahead of schedule.
LLS's enrollment represented 62% of the total enrollment. Without LLS's innovative approach, the client indicated it would have taken an additional two months to close enrollment, resulting in a loss of time and money to the sponsor.
Our Efforts Resulted in:
5,712 patients enrolled 4 months
62% of total enrollment 2 months saved
Built on decades of trust and loyalty, LLS commits to regularly communicate with subjects enrolled into the study to sustain their interest for a future interventional study at an investigator site.
"I had the opportunity to work with Life Line Screening (LLS) on a large clinical study. LLS leadership showed full engagement and continued their enthusiasm through to study closure. The teams did a great job and core management was extremely responsive and flexible to all study needs and requests."
"This was a great experience and I would definitely enjoy working with LLS again on future projects."
–Clinical Research Partner, 2019