BOSTON & GENEVA--(BUSINESS WIRE)--PHT Corporation is the first and only electronic clinical outcome assessment (eCOA) provider approved to train raters on the electronic Mini International Neuropsychiatric Interview (M.I.N.I.) for clinical trials. PHT is the leading provider of technologies used to collect patient-driven eData for clinical research.
The M.I.N.I. is a short, structured diagnostic interview developed for DSM-IV, DSM-V and ICD-10 psychiatric disorders. PHT is the first to implement the electronic M.I.N.I. in a web browser based environment, the PHT NetPRO™ System, for use in global clinical trials. When using the NetPRO version of the M.I.N.I. interviewers provide data responses electronically via the web. This provides cleaner data and streamlines patient interviews and scoring as compared with the paper version.
Clinical rater variability can be significant within clinical trials, and directly impact the quality of clinician reported outcome assessments. PHT has developed a customized dual training approach for improving data quality and optimizing the uniformity of clinician-reported data capture across clinical studies that is approved by the developer of the M.I.N.I., Dr. David Sheehan. Rater training for the M.I.N.I. features programming elements combined with training specific to the electronic implementation, and provides training evidence required by FDA CFR Part 11 §10(i). Curriculum development is based on the industry standard for instructional design practices, and includes online modularity for rapid review and refresher training.
Rater training for clinician reported outcomes (ClinROs) improves data accuracy by reducing leniency, severity, halo, first impression, and friendship bias. It clarifies the instrument’s performance dimensions used in the evaluation system and advances the detection, perception, and recall of actual performance.
Dr. Susan Dallabrida, PHT Vice President of Clinical Science and Consulting, explains rater training and its critical importance to quality ClinRos in this brief video: http://bit.ly/1zfFXOu.
Dr. Dallabrida explains, “Studies show that clinical experience does not substitute for rater training, which has been proven to reduce instrument scoring deviation and variability among raters. Rater training standardizes and unifies the process, improving clinical trial data quality. Adding M.I.N.I. rater training to the portfolio of Clinical Science and Education Services available to sponsors and CROs enables determinations on drug efficacy and/or safety to be made faster and more accurately, for the ultimate goal of improving clinical outcomes and patient health.”
Dr. Dallabrida added, “Industry research confirms that clinical interview quality is a key determinant of whether a drug candidate attains efficacy and/or safety endpoints in trials.”
Download more information on PHT Rater Training: http://bit.ly/ratertraining.
Read the news story in Clinical Informatics News: http://bit.ly/CINRaterTraining.
About PHT Corporation
PHT Corporation is the eClinical innovator leading the adoption of patient-driven mobile apps for better clinical research. The PHT electronic clinical outcome assessment (eCOA) system collects and reports secure real-time patient data from the latest mobile devices. PHT scientific, regulatory and technological expertise combined with quality outcomes data enable clients to make research decisions with confidence. Sponsors and CROs have leveraged the PHT Patient Suite in 675+ trials resulting in 21+ regulatory approvals. Visit phtcorp.com for more information on PHT. Follow PHT on LinkedIn, Facebook, Twitter, Google+ and YouTube.