Clinical Research Unit

Hot flash patient enrolment is particularly challenging due to the scarcity of patients fitting qualifying criteria. By definition, moderate hot flashes can cause disturbance in sleeping patterns, overheating and profuse sweating. For patients experiencing severe hot flashes, episodes may even require action to cool off. A sponsor was conducting an early phase clinical trial for female patients with hot flash symptoms. Potential subjects were required to keep a diary documenting daily hot flash symptoms over a 4-week qualifying period.

Eligible women were required to document a baseline average of ≥7 and ≤20 moderate to severe hot flashes per day during the last week of screening. In addition, eligible women had to experience a change of <50% in average 24-hour hot flash frequency between the first and second week of the screening period.

As a result of such stringent eligibility requirements, the site had to recruit more than the average number of subjects in order to successfully screen patients.

Generic hot flash advertising was placed into market for 14 weeks prior to study start in order to create interest. Advertising creative included a variety of media including flyers, print ads, Facebook ads, digital copy and digital billboards which took a light-hearted approach to the serious and often frustrating side effects of menopause. This was in an effort to pique the interest of postmenopausal women to engage patients, build up the database, and simplify the recruitment process.

During the 14-week period, the hot flash study was promoted to more than 2,400 female callers. ICON’s early-phase group was successful in adding over a hundred postmenopausal females (experiencing hot flashes) to the database before the study was opened for recruitment. Adding subjects to the database enhanced patient recruitment outcomes. Furthermore, ICON’s assistance and advertising strategy aided in streamlining the early-phase study design for the sponsor.