Clinical trials frequently rely on clinician-rated instruments and patient-reported outcomes (PROs) as pivotal endpoints. Often these scales rely on clinical subjectivity and individual interpretation, thereby creating the potential for variability across sites – sometimes resulting in failed studies.
UBC believes that improving the competency of the data collection “vehicle” – whether patient or clinician – through customized training and validated assessment programs will reduce unnecessary data variance, thereby increasing the likelihood that a trial will be successful.
In fact, our programs target all individuals involved in data collection: patients, investigators, sub-investigators, site clinicians, study coordinators and other site personnel.
UBC’s programs can:
- Increase understanding of target disease areas
- Enhance accurate diagnosis and appropriate patient enrollment using screening instruments
- Certify raters to conduct research interviews, administer and score rating instruments and maximize concordance with standardized scoring conventions
- Strengthen regulatory submission packages through in-study ratings surveillance and reliability activities
Beyond the inherent subjectivity of both clinician-rated and patient-reported endpoints, operational complexities can insert variances that must be recognized and understood. These include:
- Multi-national programs that introduce both cultural and language differences
- Placebo response
- Large studies that may require sponsors to recruit less experienced sites
- Long programs that typically suffer from staff turnover at sites
Because we are acutely aware of these operational challenges, we develop our training and assessment programs to neutralize their potentially negative impact.
More specifically, UBC’s programs include:
- Culturally balanced curricula and translated materials
- Blended learning techniques and venues to leverage both live and self-paced training
- Segmented tracks to accommodate both the experienced and less experienced “student”