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Skin So Simple: Myth Busted
Clinical research in dermatology has a reputation for being simple and easy to conduct compared to other therapeutic areas. Developing therapies for the largest organ in the human body is not an easy task. For starters, dermatological conditions represent one of the most common health problems in the United States with an estimated one third of Americans suffering from at least one skin condition. Each year nearly 85 million Americans visit a physician for at least one skin disorder, costing the U.S. healthcare system over $90 billion annually. Also, it is true that trials don’t always have the morbidity, complex study design, or rarity factors of other indications, however the myth that dermatology studies are simple isn’t exactly accurate. There are a number of specific challenges that affect dermatology alone and here we will present some reasons why there is more to these studies than meets the eye.
Roadblocks to Recruitment
One of the most unique challenges to recruitment for dermatology trials is something many of us can’t avoid, the sun. This is because many skin conditions and their treatments depend on getting just the right amount of UV exposure. Environmental restrictions are present in many other therapeutic areas, however few are quite as difficult to work around as strict limits for sun exposure and no other therapeutic area encounters such frequent environmental restrictions in study design. Recruiting patients in May for a three month trial requiring limited sun exposure anywhere south of the Mason-Dixon line can be nearly impossible.
The solution to this challenge lies in the implementation of strategic recruitment tactics and the best tactics vary from trial to trial. In south Florida, we are very familiar with the sun and the challenges it presents to clinical research. Sites can be identified and selected utilizing algorithms that account for selected variables such as ambient sunlight. Variables can further be reduced by providing sunscreen free of charge to sites in sunny places. In addition to tactful recruitment strategies, big data can be leveraged to increase the speed and accuracy of patient recruitment and cohort generation by tapping into data from historical clinical trials offering early insight and reducing failure rates.
Retention Strategies are the Key
The average patient drop-out rate in clinical trials is estimated to be around 18% with dermatology trials being higher due to a number of factors including lack of proper education, concurrent use of over the counter skin products and the presence of disproportionately large adolescent population. This is specifically seen with acne trials and many clinical trial protocols require strict adherence to rigorous regimens to prove safety and efficacy, however getting younger participants to follow complicated protocol procedures can be a daunting task.
Teenagers are not known for being compliant, especially when it comes to following directions and being punctual. This presents a problem for investigators seeking to generate quality data and bring new therapies to market. In a recent trial in jeopardy of failing due to drop outs, the study was rescued by providing gift bags and information pamphlets explaining the study. Integrated technology platforms, such as mobile apps built on an EDC system, not only provide quality education, they enable researchers to push data back to patients for ongoing feedback and communications. The introduction of mobile health tools is encouraging more patient-centric research practices—alleviating patient burden and improving compliance and retention.
A Not So Simple Solution
Skin isn’t so simple after all and dermatology trials pose some unique challenges that require the attention of an experienced study team. With so many factors affecting the success of a trial, designing and conducting dermatology trials can be tricky. Enhanced training for patients and investigators may be sufficient for some trials while others may need a complete change in study design. The integration of new data sources and innovations in mobile health are already streamlining manual, resource-intensive processes leading to accelerated timelines and achievement of key milestones.
Through effective education and optimization of data-driven insights, the barriers to recruitment and sustained enrollment in dermatological trials can be conquered. Over a decade of experience conducting dermatology clinical trials has given us insight on historical metrics by integrating new data sources, leveraging machine learning and deploying data science solutions into the clinic ultimately increasing the success rate of dermatology trials and helping to improve patients’ lives.