Your CRO of choice for pain studies
PRIMARY PAIN ENDPOINTS &
Most trial patients find it cumbersome to record data in paper diaries provided to them to capture patient outcome, especially when they are in pain. However, according to the FDA Guidance, efficacy endpoints in an analgesic trial should reflect a direct rating of pain intensity by the subject for all settings in which subjects can communicate in a reliable manner. Reducing the burden for patients in clinical trials is imperative for achieving good compliance, which is also the basis for high quality data. At SCOPE we use electronic clinical outcome assessments (eCOA) to facilitate data capture by patients (e. g. ePRO, eDiary) and site personnel by collecting the data through an app or via web on provisioned or personal devices such as tablets, smartphones, or PCs.
CLINICAL ENDPOINTS IN PAIN STUDIES
SCOPE works with selected providers for electronic Clinical Outcome Assessments (eCOA). Our monitors also assist study coordinators in training patients to complete self-rated pain scales, ensuring timely capture and review of responses captured through patient diary data. Our site communications continually emphasize training, assessment, and feedback with sites to provide quality and consistency across all study sites. Our trained project managers identify and mitigate study risks at the outset. In case of participation of young children or subjects who cannot provide self report, observers (e. g., parents, caregivers) can report on observable indicators of disease or health condition through measurement of an observer-reported outcome (ObsRO). ObsRO concepts include only those events, behaviours, or signs that can be detected by an observer’s senses (i. e., wincing, crying, or squirming). Similarly, a clinician reported outcome instrument to be completed by the study investigator should be limited to those concepts that are observable.
- Pain intensity
- Global single item assessment
- Opioid sparing
- Health related quality of life
- Rescue medication
CONTROLLED DRUG MANAGEMENT
SCOPE has extensive experience in the requirements for handling of controlled drugs / narcotics with a network of local offices capable of ensuring compliance with local regulation and avoiding issues with handling.