Many factors can affect the cost and rate of enrollment of a dermatology clinical study. Partnering with a specialty dermatology CRO to offer insights on historical metrics, or create new configurations, can help keep studies on-time and on-budget. In this post I highlight two unexpected challenges that could cause fluctuations in both costs and timelines of a dermatologic clinical trial.
Consider the season
Sponsors often begin planning with a predetermined time table for study completion based on the success of a previous phase or similar study. It is important to note, however, that dependent upon the indication involved in the study, the time of year may influence the enrollment timeline.
How warm weather can affect enrollment
Seasonality may have an impact on timelines and costs associated with trials evaluating conditions such as psoriasis and atopic dermatitis. In the warmer summer months, depending upon the indication’s severity, flare ups may tend to be less prevalent, which can reduce the recruitment pool. In one example, Novella Clinical was selected to enroll 700 psoriasis patients from May to August, with two sets of inclusion/exclusion criteria. Using our predictive enrollment model, we recommended a strategic recruitment plan that not only front-loaded the enrollment to get in as many patients as possible early in the season — ensuring adequate enrollment — but also overlapped the recruitment to attract the harder-to-find patients first, while still enrolling the more prevalent criteria.
In a second example, a Phase II, multi-center atopic dermatitis study was falling behind in enrollment, prolonging the enrollment period into what looked to be the summer months. Our patient recruitment team created an intervention plan that concentrated efforts in regaining the sluggish enrollment in autumn, when the condition tends to worsen. Our team was able to complete enrollment two weeks early, exceeding the study timeline.
Competition in the OTC market
Another challenge for many dermatology studies is the availability of over-the-counter (OTC) offerings to treat the same condition. In the case of acne vulgaris, there are a large number of OTC offerings readily available for people suffering from this condition. This may make it less likely that subjects would be willing to participate in a clinical study for a potential new solution. A novel approach to targeted advertising, based on the demographic need for the study population, can often prove effective in reaching the right audience to successfully fulfill the enrollment requirements of the study.
These are just two examples of a number of challenges that could arise when planning a clinical trial.
Do you need dermatology patient recruitment management support? Our patient recruitment team would be happy to share our experience and help you uncover potential obstacles and provide custom recommendations to help ensure the success of your dermatology clinical trial. Contact us.