Dermatology studies demand careful planning and precise execution to ensure the reliability and validity of research outcomes. This blog highlights five key operational considerations that can greatly enhance the success of dermatology clinical research. By addressing these factors, drug developers can streamline operational efficiency, safeguard data integrity, and achieve their study objectives more effectively.
1. Incorporate Innovative Thinking
Dermatology studies demand creative and tailored strategies to address the unique challenges and opportunities inherent in the field. By fostering a mindset of out-of-the-box thinking, researchers can develop more impactful study designs, improve patient engagement, and ultimately drive enhanced study outcomes. Designing the study with the patient in mind to reduce the patient burden will aid in patient recruitment. For example, ensuring the necessary in-clinic visits are supplemented by remote visits, or reducing the need for biopsies throughout the study.
2. Promote Rater Consistency to Ensure Reliability and Validity
Rater consistency is vital for ensuring the reliability and validity of research findings, as rater results are typically a primary endpoint. Promoting rater consistency involves:
- Deploying Rater Training Materials: Help ensure raters are well-versed in the assessment criteria with comprehensive training programs.
- Managing Vendors: Partner with reliable vendors to help provide standardized and high-quality training and support along with qualified central readers.
- Tracking Performance: Regularly monitor rater performance across visits to identify and address any inconsistencies and intra-rater variability. Vendor experience in masking and de-identifying patient images is critical.
3. Address Rate-Limiting Factors During the Proposal Process
A dermatology clinical trial can face several challenges in the study startup phase. Drug development sponsors must ensure they have a plan for:
- Creating Intuitive ePro Questionnaires: Ensure electronic patient-reported outcome (ePro) questionnaires are intuitive, patient-friendly, and comply with regulatory standards because many responses in dermatology studies are subjective, well-designed questionnaires are critical.
- Securing All Licenses: Obtain all necessary licenses and permissions for using specific validated scales and patient or investigator questionnaires. This rate-limiting step should be addressed as early as possible upon study initiation.
- Ensuring Accurate Translations: Offer linguistically accurate and culturally relevant translations of study materials to facilitate clear and effective communication with participants.
4. Optimize Your Timeline for Effective Planning and Management
Effective planning and management of the study timeline are critical to the success of dermatology studies. Key strategies include:
- Accelerating Study Start-Up: Streamline the dermatology study start-up process by utilizing a comprehensive library of site documents and contract templates— dermatology-specific where applicable—which also help boost investigator engagement.
- Leveraging an Investigator Network: Leverage an established network of dermatology investigators and study sites to minimize site qualification visits, thereby expediting the overall start-up process. Sponsors should also ensure the appropriate collaborations are in place for study needs. For example, a study of radiation dermatitis will require a dermatologist as the primary investigator and a radiation oncologist as the sub-investigator.
5. Reduce Source Data Verification to Enhance Efficiency and Cost-Effectiveness
Reducing source data verification (SDV) is vital for enhancing the efficiency and cost-effectiveness of dermatology studies. Utilizing a central monitoring process, powered by a risk-based monitoring tool, offers several advantages, such as:
- Identifying Trends and Outliers: Detect trends and outliers in data using centralized review, ensuring that specific data points, such as lab values, are not redundantly verified in electronic case report forms (eCRFs).
- Reducing Duplication of Work: Minimize the need for redundant data verification, saving time and resources.
- Lowering Costs: Reduce site and study costs by streamlining the data collection process.
Drive Your Dermatology Study with a Fit-for-Purpose Approach
Improving the effectiveness and reliability of dermatology studies requires a personalized approach that promotes innovative thinking and ensures rater consistency. Sponsors should plan ahead to address common challenges faced in study start-up, optimize their timelines, and increase efficiencies in monitoring to deliver quality data.
Set up a time to speak with one of our dermatology experts and learn about our solutions for advancing your study.