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European Pharmaceutical Contractor

A Blemish on Good Science

In scientific research, objective data collection is critical to making conclusions that are free from bias. The importance of minimising subjectivity is particularly important in dermatology clinical trials where clinically acceptable methods of assessing disease symptoms or treatment response are largely based on a physician’s subjective assessment.

Dermatologists assess skin lesions and treatment responses using different observer-rated scales, such as the Eczema Area and Severity Index (EASI) and the Psoriasis Area and Severity Index (PASI). Both rely on visual assessments of symptoms, such as erythema (redness). This traditional approach of ‘eye-balling lesions’ results in subjective measurements prone to inter- and intra-observer variability (1). They can even vary at different times of the day.

Developing processes to objectively measure outcomes in dermatology clinical trials should be a priority for sponsors and investigators in this field. Thought leaders, including Dr James Milbauer, believe that, in the not-too-distant future, imaging technology and software will enable clinicians to scan, measure, and objectively assess patients and clinical trial participants (2). Until this technology becomes a reality, the pharmaceutical industry will continue to rely on alternative established strategies to mitigate the current lack of objectivity in measuring outcomes for dermatology trials. This article will discuss these strategies and the research that has created the first steps towards objective measurements for dermatology trials.

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Dr Elisabeth Rowold, Director of Project Management in the dermatology division (Europe), has more than 23 years of experience in the pharma industry and more than 14 years of experience in the conduct and oversight of clinical trials spanning all phases of cutaneous safety and efficacy studies. Elisabeth oversees the Novella Project Management activities in Europe and is responsible for providing strategic leadership, organisation, training, and ongoing evaluation and support to the Clinical Operations group.
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Dr Elisabeth Rowold
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