High-Volume Low-Variability Surgical Models

High-Volume Low Variability acute pain Surgical Models

By utilizing our acute pain recruited Surgical Model, Lotus decreases enrollment time and overall project cost substantially. Instead of recruiting acute pain patients in the conventional way, waiting for patients who have the condition of interest to present themselves to the hospital for surgery, Lotus actively recruits patients using newspaper, radio and television advertisements. Our location within a large metropolitan hospital gives us the ability to apply this model to multiple surgical indications and enroll an average of 8-10 patients per week. Project costs can be reduced by 30+% over a larger multicenter trial as a result of; less time for investigator recruitment and training, CRA travel, project management, etc.

Has this been done before?

Yes; well sort of. The business methodology employed is similar to recruitment strategies historically used for bunionectomy and third molar extraction studies. The difference is that Lotus has applied those techniques to a large variety of outpatient surgical procedures. Pharmaceutical sponsors who are interested in highly standardized and regimented surgical trials no longer need to be relegated to bunionectomy and third molar extraction.

Features of the Lotus recruited Surgical Model:

The Lotus model has significant advantages over the conventional methodology for recruitment into surgical trials. The standard methodology necessitates a "watch and wait" approach; the surgical calendar is examined for pre-existing cases and subjects are queried as to their interest in participating in an investigational process. In contrast, the Lotus model utilizes an active campaign of subject recruitment. Multiple media types are utilized including web based advertising, television and newspaper. Subject accrual is rapid and reliable. Lotus performs the operation and the subsequent surgical stay within its own research facility allowing for a high degree of standardization and control.

Conventional Surgery Model Lotus Recruited Surgical Model
Surgical Model Hysterectomy, knee replacement, hip replacement, abdominal surgeries, etc. Bunionectomy, hernia repair, laparoscopic cholecystectomy, hemorrhoidectomy, arthroscopic knee surgery, arthroscopic shoulder surgery, tummy tuck
Recruitment Strategy Accrual from existing practice and surgery calendar…"watch and wait" for patients Active recruitment using television, radio, newspaper advertisements, as well as surgery calendar
Ethics Review Local IRB (4 – 8 weeks) Central IRB (2-4 weeks)
Standardization Hindered by large healthcare team involved in hospital-based patient care Optimized secondary to research team providing all care. Surgeon, anesthesiologist and nurses are all part of the study team
Cost Increased secondary to need for multiple centers and high degree of coordination on behalf of the CRO Decreased secondary to high-volume patient throughput. Project costs can be reduced by 30+% over a larger multicenter trial as a result of; less time for investigator recruitment and training, CRA travel, project management, etc.