Your CRO of choice for PAIN studies
Our pain management study teams here at SCOPE International have experience in conducting a wide variety of clinical studies including mild, severe, acute, chronic and breakthrough pain indications. With a full range of services and profound experience, we are able to define a strong development plan for your drug, device, or combination product and oversee the study from concept to delivery.
SCOPE International has successfully conducted more than 54 pain studies involving more than 1,600 clinical sites and 12,000 patients in both adult and pediatric pain indications. We have established networks of investigators across a variety of pain indications; by maintaining close relationships with neurologists, pain clinics, palliative specialists, surgeons, anesthesiologists, general practitioners, and key opinion leaders (KOL), we are able to provide rapid and accurate feasibility estimates at outset. We build upon our well-established relationships with experienced, qualified and motivated sites to ensure the success of your trial.
Your program will be monitored by experienced clinical research associates, project managers, and medical monitors who are familiar with the specific nuances of these types of studies. Moreover, because pain is a subjective experience, the choice of an adequate instrument to measure the primary endpoint is essential to demonstrating the efficacy of an analgesic. Our staff can advise on selection of appropriate, well-defined and guideline-conforming tools including those suitable for use in the setting of a clinical trial to measure change over time. These include all the commonly utilized tools such as:
•_Brief Pain Inventory
•_MPI, Mood and Symptom Questionnaire
•_West Haven Yale Multidimensional Pain Inventory
•_Neurological Impairment Set
•_Numeric Rating Scales
•_Visual Analog Scales
EXPERIENCE IN PAIN
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. Communication with the site emphasizes training and assessments, and provides feedback to help ensure 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 conditions through measurement of an observer-reported outcome (ObsRO). ObsRO concepts include only those events, behaviors, 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 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.