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It is our privilege to extend a warm welcome to Janet Overvelde, Senior Director, Project Management at Innovaderm Research, an esteemed industry leader. Her impressive portfolio in project management is marked by a consistent commitment to the research sector. In our discussion, we will be exploring the importance of rater training, focusing on the following points:
- The influence of rater training in dermatology
- Preserving Clinical Outcome Assessments (COA) data quality
- Optimizing COA data capture
Rater Training: Key to Dermatology Trial Success
Rater training significantly impacts study design, the measurement of endpoints, and the interpretation of data, all of which are critical for achieving the regulatory approval our sponsors aim for. The association of rater training with primary, secondary, or exploratory endpoints of a trial dictates our strategy for the setup and execution of these instruments.
COAs: Shaping Clinical Trial Efficacy
COAs, such as Clinician-Reported Outcomes (ClinRO) or Patient-Reported Outcomes (PROs), are instrumental in shaping study design. They determine the endpoints to be measured, guide data interpretation, and are crucial for obtaining regulatory approval. The association of these instruments with primary, secondary, or exploratory endpoints significantly influences our approach to their setup and implementation within the trial.
Strategies to Ensure COA Data Integrity
Ensuring quality COA data is a critical aspect, and it is essential to move beyond a “plug and play” mindset. Collaborating closely with sponsor partners to assess COA needs is key, taking into account factors like cultural relevance, geographical context, demographics of patients, caregivers, and clinicians, as well as the translation methods, and the format and delivery of training. It is imperative to safeguard and mitigate risks to maintain the data’s adequacy and appropriateness within the trial.
Optimal rater training, ideally led by a key opinion leader or the developer of the assessment tool, is crucial. Regular review of rater training, certification, and recertification frequency throughout the trial’s lifecycle ensures that the implementation and evaluation of these tools are standardized. Our team prioritizes not only the certification of raters but also that of core project team members, including Principal Investigators (PI), medical monitors, and clinical trial managers . This comprehensive certification supports the sites, PIs and overall trial conduct, ensuring everyone involved has the necessary knowledge, comfort, and expertise with these tools.
Maximizing Efficiency in COA Data Capture
At the heart of our efforts are our patients, for whom we strive to secure the best treatment options available globally. Our sites are the vanguard in this endeavor, working hand-in-hand with patients. In today’s technologically rich landscape, a plethora of technologies and vendors are at our disposal to aid in data collection. It is crucial to adopt the easiest approach for end users, keeping a frontline perspective to facilitate their role in these vital components of clinical research.
Considerations such as the user-friendliness of interfaces on tablets, phones, or web-based tools, and the clarity and simplicity of platform navigation are paramount, given the wide range of technology literacy across various ages, demographics, and geographies in research. Thoughtful consideration of these factors is essential when implementing a trial. Ultimately, we aim to harness the insights of our esteemed collaborators and partners, including PIs at our sites, to enhance this experience for everyone involved.
As we conclude another illuminating episode of Phase forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon in statistics lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease, stay at the forefront of knowledge and innovation, and follow. Phase forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.
Let’s shape the future of research and make a difference in the industry, gain Innovaderm’s support in your upcoming trial and propel your study to new heights
