MedAvante: Solutions

By: Medavante  06-Dec-2011
Keywords: Cns Clinical Trials, Patient Enrollment,

MedAvante: Solutions

MedAvante is dedicated to bringing certainty to the mental-health evaluations and assessments performed during CNS clinical trials. Our methodology provides advanced signal-detection solutions for diagnostic, screening, and symptom-severity assessments. By applying this methodology, MedAvante overcomes the major threat to achieving signal detection: Issues with the trial assessments’ validity and reliability caused by biases and interviewer variability. Our solution provides:

  • Appropriate patient enrollment according to protocol
  • No baseline score inflation for reduced placebo response
  • Highest inter-rater reliability due to continuous calibration

Traditional CNS trials suffer high rates of failure, increasing rates of placebo response and inappropriate patient populations. Until recently, these problems were addressed  through rater training at the outset of a trial. Periodic retraining during the study to minimize rater drift could further reduce the problem. However, up until now, this has not been operationally feasible as it does not address ‘noise’ introduced by bias and even the best trainers can each vary in their interpretation of the scales’ conventions and scoring criteria.   

An entire cohort of study raters comprised of high quality interviewers can still result in poor reliability for the study as a whole, with an attendant negative effect on study power.  That is because each site is managed independently and the sites do not continuously calibrate with each other on what are fundamentally subjective measurements.  In addition, over the past ten years the number of investigative sites, with their attendant raters, has significantly increased to meet the patient needs of many studies contributing to study variability and signal noise.

Most importantly, the highest risk factors for a successful trial are posed by biases, specifically enrollment bias and the related baseline score inflation at study outset that can nullify the beneficial impact of even the highest quality interviewing. 

Keywords: Cns Clinical Trials, Patient Enrollment,

Contact Medavante

Email - none provided

Print this page

Other products and services from Medavante

06-Dec-2011

MedAvante Products & Services

Sponsors of CNS clinical trials can select precisely the level of service needed to achieve their goals for signal detection, study power, and inter-rater reliability. Toward that end, MedAvante offers four levels of service, each based on our highly precise methodology for increasing objectivity in CNS studies. MedAvante is dedicated to bringing certainty to the mental-health evaluations and assessments performed during CNS clinical trials.


06-Dec-2011

Remote Centralized Ratings

MedAvante’s Remote Centralized Ratings service addresses issues of baseline score inflation and expectancy bias by providing the services of expert, clinical raters working remotely from a central location. The result for sponsors is the highest level of certainty in maximizing the value proposition for their CNS products and delivering effective therapies for treating debilitating CNS diseases.


06-Dec-2011

Continuous Quality Control Monitoring Service

Provides own score of interview scale: automated workflow program will not provide site's scores until MedAvante expert trainer enters their assessment scores. MedAvante expert trainers are calibrated to provide consistent feedback to all site raters to minimize rater variability. Site-based raters digitally record all their subject interviews through provided laptop. Calibrate the site raters to the central MedAvante expert trainer cohort.


06-Dec-2011

MedAvante Patient Ascertainment

MedAvante can dramatically improve the accuracy of patient ascertainment by employing a bank of centralized calibrated expert raters to qualify patient enrollment during the initial screening process. By enrolling the right subject and accurately assessing their baseline symptom severity, MedAvante Patient Ascertainment service increases objectivity in CNS clinical trials.


06-Dec-2011

MedAvante Rater ReadinessTraining

To provide the highest levels of rater training, MedAvante offers enriched Rater Readiness training, a superior approach that puts extraordinary emphasis on the rater's applied interviewing skills which is representative of real world trial conditions. The result can be greater certainty in maximizing the value proposition for CNS products and delivering effective therapies for treating debilitating CNS diseases.