Dermatology clinical trials address skin diseases that may not be adequately treated with currently approved medications. These diseases include atopic dermatitis (eczema), psoriasis, acne, rosacea, nail fungus, skin cancer and many others.
How Do Dermatology Clinical Trials Differ from Other Medical Trials?
Dermatology clinical trials are very unique and can differ from other therapeutic area clinical trials. For example:
Fast Study Start-Up
Dermatology trials often do not require extensive supplies or equipment, which makes it easier for researchers to set up studies when compared with other fields. Most supplies are readily available and easy to ship enabling the clinical sites to have everything they need in order to start screening subjects.
Most dermatology trials can recruit independent clinical research sites or private practices that are able to use central IRB services. Anyone who has ever worked with academic clinical research sites can attest that utilizing a central IRB can save a significant amount of study start up time for review and approval of essential documents, thereby, enabling sites to be ready to meet their first patient screened timelines.
Subjective Primary Endpoints
Dermatology clinical trials are different from other therapeutic areas partially due to the role of the investigator in assessing the skin disease. Most dermatology protocols include a primary endpoint of investigator grading and assessment of the particular indication. This can lead to some challenges with ensuring consistent data throughout the trial.
The success of a dermatology study depends highly on minimizing variability in the data. Training is key to ensuring consistency. Experienced sites and investigators should be a priority during site feasibility. Trying to utilize less sites can also help with limiting the variability in scoring assessments. Furthermore, training investigators on the grading scales prior to study start and periodically re-training throughout the trial can help ensure consistency not only between investigators but also for each investigator alone. Sponsors should consider breakout training sessions during the investigator meetings to conduct tests on the scales and issuing training certifications to the investigators that will assess the efficacy endpoints.
Unlike other therapeutic areas, dermatology indications can tend to affect normal healthy people who may have acne or atopic dermatitis. These people may try to treat their skin disease by themselves and may not be under the care of a dermatologist. Therefore, frequently, dermatology studies rely on advertising to recruit potential study subjects.
In our experience, utilizing many different types of media for advertising a trial can prove beneficial for finding study subjects. Social media, radio, TV and even print ads reach a wide range of people that may be suffering from a certain dermatology indication. Utilizing a central website or call center to pre-screen potential subjects that answer the ad is key to minimizing screen failures and also can help limit burden on the site during the recruitment and enrollment process.
Ensuring patient retention is another area that can make dermatology studies unique. Again, since some of the study subjects may be healthy people with a mild or moderate skin disease, the incentive for them to stay in the study and return for follow up visits can be a challenge.
Devices/apps for ePRO and diaries that include reminders, study information, and updates can improve retention and encourage subjects to complete all study visits. Building a relationship between the site staff and subjects can also play a role in patient retention. Subjects may be more apt to return for follow up visits if they feel loyal to the investigator or study coordinator.
Dermatology Contract Research Organizations and Clinical Trials
Clinical trials are the only way to determine if a drug is safe and effective. They also help understand how it will be accepted by the medical community once it is commercialized. However, undertaking a dermatology trial, one must keep in mind the different designs and management needed in order to ensure the trial is a success.
A dermatology CRO like Vial not only has a clear understanding of these intricacies but also has access to appropriate dermatology patient populations through the Vial site network. The Vial model is set up for success. With highly experienced CRO staff along with the experienced dermatology sites, Vial can execute dermatology trials faster and ensure higher quality in order to meet timelines and expectations.
Vial’s mission is to run clinical trials with faster execution and higher quality in order to bring new therapies to market. Vial has over 70 employees and is based in San Francisco, California. Vial partners with Dermatologists to support their research teams and has created a network of over 35 Dermatology clinics. The Vial network has contributed to over 150 trials for many of the leading sponsors in Dermatology having run trials across common Medical Dermatology indications (Atopic Dermatitis, Psoriasis, Vitiligo, Alopecia Areata, Rosacea, Hidradenitis Suppurativa, Prurigo Nodularis among others) as well as Aesthetic Dermatology indications. The clinic network runs trials from Phase I through Phase IV.