Skin diseases are the fourth leading cause of human health problems, affecting nearly 900 million people around the world [1-2]. Dermatology drug development projects have increased significantly in recent years. Currently, there are hundreds of clinical trials ongoing or in the

Dermatology is the fourth leading cause of human health problems, affecting nearly 900 million people around the world [1-2]. Dermatology drug development projects have increased significantly in recent years. Currently, there are hundreds of clinical trials ongoing or in the planning stage around the world for skin diseases such as atopic dermatitis , psoriasis, and melanoma [3].

In this new era of intense competition, sponsors are under greater pressure than ever to optimize clinical development strategy and planning. To help sponsors optimize clinical development strategy and planning, Premier Research's team of experts provides insights into the key considerations for conducting dermatology clinical trial study design and conduct in this new era.

Addressing unmet needs in dermatology

There are more than 3,000 common and rare skin diseases known, and for most of these diseases there is a significant need for safe and effective treatments. To date, many relevant research results have been limited to a small number of disease areas. In the highly competitive field of dermatology therapy development, sponsors must carefully evaluate study design and conduct to gain a competitive advantage and increase the probability of trial success.

Research Design Considerations

When developing a research proposal, it is important to identify all potential risk factors and develop a response plan. A strong focus on patient safety is a powerful decision-making framework when conducting study design. How to safely conduct patient recruitment, enrollment and follow-up, and how to ensure that patients feel safe enough to participate in clinical trials, are the primary issues that sponsors need to pay attention to.

Incorporating patient feedback into protocol design is important because doing so can help sponsors gain a competitive advantage, especially in indications where clinical trial activity is high or where the number of eligible patients is small.

Trial Operation Considerations

Based on rich clinical trial experience, Premier Medical’s expert team proposed key trial operation considerations that are conducive to the success of dermatology research:

1, accelerated start-up

and contract research organizations with comprehensive investigation networks (CRO) collaboration to help simplify the research start-up process. Taking Premier Pharmaceuticals as an example, it has close cooperative relationships with many research centers around the world, which may help simplify or eliminate the screening visit procedures of research centers, thus saving time for sponsors in the initial research center participation process. In addition, factors such as patient-reported outcomes questionnaire clearance and document translation can have a significant impact on the study process, and starting the relevant procedures as early as possible can help ensure that the study process is not affected.

2. Ensuring rater consistency

Ensuring rater consistency is important to the success of dermatology studies and their associated regulatory submissions. Sponsors should have processes in place to create and conduct assessor training and document assessor assessment results at each visit and this should not be overlooked.

3. Reduce the need for key data original file traceability (SDV)

Minimizing the need for key data original file traceability (SDV) helps reduce duplication of work, research center working time and research costs. The risk-based monitoring (RBM) system provided by Premier Pharmaceuticals can start analyzing data in real time immediately after the data is entered into the electronic case report form. By using this system, sponsors can ensure that all data are reviewed, ensuring data quality while reducing SDV.

Premier Pharmaceuticals’ monitoring results of the emerging field of dermatology show that as many sponsors compete to enter this track, clinical research work in related fields is facing increasing competitive pressure. By cooperating with CROs who have extensive experience in the field of dermatology research, it helps sponsors optimize clinical development strategies and plans, thereby effectively improving the speed and success rate of products obtaining regulatory approval.

About Premier Research

Premier Research currently has a full grasp of oncology and hematology, rare diseases, neuroscience , global development and registration strategies and other fields.Relying on 20 years of product development experience, the company can provide one-stop comprehensive services from initial strategy formulation, clinical development to final regulatory submission. Search "PremierResearch" on WeChat to learn more about the world's leading industry insights and real case analysis.

Reference:

[1] Seth D, Cheldize K, Brown D, Freeman EF. Global burden of skin disease: inequities and innovations. Curr Dermatol Rep. 2017;6(3):204-210.

[2] World Health Organization. Recognizing neglected skin diseases: WHO publishes pictorial training guide. Available at https://www.who.int/neglected_diseases/news/WHO-publishes-pictorial-training-guide-on-neglected-skin-disease/en/ .

[3] GlobalData, Dermatology, Relevant Clinical Trials. Accessed September 2, 2020.