Expert Insights

Expert Insights

Steps to Ensure Rater Consistency in Neurology Clinical Trials

Steps to Ensure Rater Consistency in Neurology Clinical Trials
01 August 2019

Measuring clinical trial efficacy endpoint data is critical to establishing statistically significant and clinically meaningful outcomes. High quality data collection by the certified rater is mandatory to increase chances of clinical trial success. Having one rater for the same subject throughout the entire study is “a must” and should be our top priority goal in planning neurology studies that follow the progression of age and disease. However, rater consistency throughout the study can be a real challenge.

Neurodegenerative conditions such as Alzheimer’s disease (AD) or non-AD dementias, can present variable, qualitative symptoms, making consistent endpoint assessments difficult. Even subtle changes in subject  presentation over time may not be obvious to an experienced rater. Ensuring proper qualification, training, certification, and even re-certification of raters within investigative sites is essential to provide the highest quality of assessments and minimize intra- and inter-rater variability.

We sat down with Art Wamil, M.D., Ph.D., Senior Medical Director in Neuroscience at Synteract, for insights on a few ways his department helps to ensure rater consistency in these very important trials. With 15 years of experience in neurology and neurodegenerative clinical trials, Dr. Wamil offers the following tips to help to ensure consistency across raters, sites, and regions, to control for variability when efficacy endpoint is at stake. 

  1. Plan assessments (scales) related to efficacy endpoints to show what the studied drug can do
    Studies in neurology and neuropsychiatric disorders should use validated and well-known (for sites and regulatory agencies) instruments and questionnaires. Important factors to assess to select the proper scales, which a good CRO can help with, might include:
  • requirements for use
  • administration demands
  • test-retest and inter-rater reliability
  • sensitivity and specificity
  • ability to measure change over time
  • ability of numbers generated to satisfy established scientific criteria for clinically meaningful variables

If the protocol instruments appear to be incorrectly selected, a protocol amendment should be approved immediately; otherwise there may not be any efficacy data no matter how good the drug could be. Solid documentation, early review and rater supervision, training, certification, and timely communication among raters, investigators, sponsors and CRO medical personnel could be the key algorithm to success in early assessment of how the scale performs for studied indication.

  1. Ensure one trainer (or training) for the same scale for all sites; Use Experts
    Minimum variability in the application of scales must be achieved at all sites for consistency of data. We would advise training either before or during the investigators’ meeting, where an expert in these assessments would be engaged. To avoid any significant inter-rater variability (when using neuropsychological tests, scales, and questionnaires), training should aim to provide reliable baseline and further reliable assessments over time until the end of the study.
  1. Ensure validation of rating scales, tests, and questionnaires in the target study population
    If a full validation is not available due to more recent implementation of the scale, this should be properly documented. However, the tool should at least be linguistically validated in the local language according to a pre-defined and well-designed protocol. Nevertheless, regulatory agencies would have to approve such use, and a good CRO could support relevant trainings.

Contact us today for more on how we can help to safeguard rater consistency, and go/no go decisions, in your neurology/neuroscience clinical trial.

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