The ability to create patient-centric, rapid-to-enroll clinical trials is more important now than ever. Biopharma teams are adopting decentralized models to meet these needs. One decentralized practice being utilized by more and more teams for its ability to improve data quality and reduce patient and site burden is Central Rating.
What is Central Rating?
Central Rating is the process whereby clinical trial outcome measures are administered by a focused, independent team of highly qualified raters via telehealth (video or phone).
In contrast to the traditional approach where raters are dispersed across many clinical research sites, in the central rating model, an entire cohort of raters can be uniformly and regularly trained and calibrated to increase reliability, standardizations, and scoring accuracy. This approach also allows sites to have rapid access to experienced professionals and allows participants to be assessed from the comfort of their home, reducing the number of site visits–supporting faster and more diverse recruitment.
Central rating can take place while participants are at home or visiting the site/clinic. Whether a clinical trial is fully decentralized with all assessments administered remotely, or in a hybrid scenario with both in-clinic and at-home activities, the central rating approach can be customized to meet the unique trial objectives and requirements of the protocol.
[CENTRAL RATING CASE STUDY]
See how Cogstate supports Central Rating services for clinical trial teams and gather some stats from a poster and case study here.
Benefits of Central Rating
Central Rating can significantly enhance data quality. One way this occurs is through reduced data variance due to having a smaller pool of highly qualified and experienced raters administer the tests. These raters undergo intensive rater training and monitoring that also bolsters the data quality. In addition, study designs can include more frequent testing to improve sensitivity, as participants will not have to travel to a site for each assessment.
Central rating can also reduce burden on patients and caregivers. Visits can be conducted from home, eliminating costly and time-consuming travel burdens for patients and caregivers. Visits can also be scheduled outside of normal business hours, promoting study flexibility and patient-centricity. Remote testing at-home can also mean breaking up the events incrementally to create more tolerable durations and reduce testing fatigues, as some cognitive batteries can be long (several hours). Furthermore, if a caregiver/family member is a respondent for clinical assessments (common in AD and Rare Disease), they may have other responsibilities that block them from coming into a site. Central Rating allows their inputs to be gathered remotely, increasing the likelihood of their participation.
Central Rating can also support site readiness and reduce site burden. Central rating provides sites with access to highly specialized centrals raters who may be challenging to recruit and retain locally, thus decreasing site/rater training burden and improving site readiness timeliness. In doing so, central rating broadens the types of sites who can participate in certain trials, which can positively impact recruitment outside of highly specialized trial centers.
Lastly, central rating can lead to optimized recruitment and retention, including more diverse and representative patient populations. In addition, a more diverse pool of raters can be available for test administration, supporting trial participation by minority groups who may seek specific considerations regarding language and culture. Fewer site visits can also mean increased participation by individuals from a larger catchment area, also accelerating recruitment and increasing retention.
Considerations When Adopting Central Rating
The first consideration is around scale adaptability and technology. Not all assessments lend themselves easily to remote administration by central raters.. For example, some assessment require specific technology needs ranging from the presentation of stimuli and data capture needs such as drawing items, to telehealth modalities such as telephone or video. Understanding the nuances of the clinical and cognitive assessments–their adaptability to remote contexts and their required technical enablement — are important for successful trial planning and delivery.
There also are participant support and coordination needs that surround central rating. Participant scheduling and preparation often requires site coordinators or virtual coordinators to ensure a smooth experience. When sites are responsible for coordinating aspects of remote testing sessions, it can be an new or expanded responsibility for them, requiring training and other considerations. In some instances—particularly when central rating assessments are separated by long periods without study activity–patients may benefit from reminders about appointments to supplement the automated system-generated prompts, Strong adherence to the schedule of assessments can be enhanced when there is active oversight by the site or virtual coordinators.
Lastly, there are several considerations regarding the patients’ telehealth experience and environment. It can be important to ensure participants are in a quiet, controlled environment within their home to reduce the possibility of distractions that may impact their testing.
There are also personal preferences and varying levels of comfort for both sites and participants regarding remote assessment. Central raters and virtual coordinators should develop the presence and skills to effectively engage and support participants in a telehealth context to help build the type of rapport, trust, and connection that in-person visits can provide.
Explore more about Cogstate’s Central Rating solutions and contact our team with any questions.