Centralized assessments are a method of testing clinical trial subjects that has significant potential advantages for rare and orphan disease trials. In a centralized assessment model, a small pool of trained and highly experienced raters conduct developmental and cognitive assessments either by traveling to the site or conducting the assessments remotely. So, what are the advantages of using centralized assessments in a rare disease trial?
Enable Remote Visits
Centralized assessments can also be used to move some or all of the study visits to at-home visits. Centralized assessors can conduct many assessments either over the phone or through a videoconference. Remote visits can reduce patient burden by limiting the number of trips to a site, allowing patients who reside far from clinic sites to participate when they might otherwise not be able, and protecting immunocompromised patients’ from potential exposure to germs present in clinics and hospitals.
Increase the Number of Available Sites
In a standard trial, each clinical site would need to have a qualified rater and usually a back-up rater, available to conduct any developmental and cognitive assessments that are part of the schedule of events for each study. Depending on the specialty of physicians that are likely to see patients of a particular rare disease, availability of qualified raters can limit the number of eligible trial sites. Centralized assessments allow for a larger pool of potential sites to be included in a trial. Additionally, in rare disease trials, it is important to go where the patients are. By creating a larger pool of eligible sites, sponsors can ensure that sites will be located near the patients.
Reduced Rater Training
Centralized assessments can reduce costs associated with rater training. Centralized assessments use experienced, highly qualified raters that do not require additional training. Additionally, it may reduce the number of people who need to attend the investigator meeting and the duration of the investigator meeting, both of which can represent cost savings.
Calibrated and Standardized Scoring
Centralized assessments can also increase the quality of trial data. Utilizing a small pool of experienced, highly qualified raters reduces variability in the data. Also, because there isn’t a 1:1 relationship between sites and raters, site variability is reduced. Centralized raters help ensure assessment scores are calibrated and standardized across the study.
Making Centralized Assessments a Success
Although there are many advantages to using centralized assessments in rare disease trials, there are some hurdles that must be overcome to make them successful. These can be mitigated by selecting a provider with proven experience with centralized assessments. If the centralized assessments will take place on site, there are administrative steps that must be taken to ensure that raters will have access to the site on the date of the assessment. It’s also important that the raters are experienced in both the assessments being conducted and in working with similar patient populations in order to see improvements in data quality.
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