Innovations in Clinical Trials and Decentralized Clinical Trials in CNS

All categories of CNS studies (psychiatry, neurology, pain) are heavily reliant on one or more of the following: electronic patient reported outcomes (ePROs), observer reported outcomes (eObsROs), performance related outcomes (ePerfOs) and/or clinician reported outcomes (eClinROs). At SPRIM Health, we have considerable success in helping our clients achieve ePRO, eObsRO, eClinRO and ePerfO based labeling claims.

Studies such as pain and migraine commonly require regular, often daily capture of ePRO assessments. Having experience with hundreds of these types of trials, SPRIM has developed multiple strategies for maximizing data quality, completeness, adherence and retention. These strategies are focused on outcomes optimization for pain and migraine eDiaries including eDiary design, content validation (concept elicitation, cognitive debriefing and usability testing), digital patient training/reduction of placebo effect, use of technology to facilitate compliance and incorporation of integrations with wearables and biosensors to remotely monitor patient symptoms. Further, use of real-time and near real time digital approaches for accurately track rescue medication intake have increased confidence in signal detection and help to avoid both false positive and negative outcomes.

In studies such as Alzheimer’s disease and seizure, it is very common to rely upon observer reported outcomes to capture events. Reliance on a observer (who is also a caregiver) adds another layer for confounding variables on efficacy and safety signals. At SPRIM Health, we understand how important it is to educate observers about their role in a study and help them shift their mindset from an emotional and labor-intensive role to being a neutral observer in a research study. Similarly, for site staff and raters one of the key elements in our digital site training offerings is also shifting their mindset and mannerisms from a therapeutic to a research alliance.

In studies for depression and anxiety, it is critical to communicate the importance of honesty and accuracy in reporting to patients, who frequently dampen responses to conform toward their perceptions of societal norms. Thus, optimizing outcomes through precision tool selection and digital patient training are key. Further, use of digital training for site raters and/or use of central raters is critical to maximize the signal to noise ratio in trials.

The use of eClinROs, rater qualification and rater training is critical in many CNS therapeutic areas. SPRIM Health has a comprehensive set of fully digital training and eClinRO solutions for many common and uncommonly used tools across, Alzheimer’s disease, Parkinson’s disease, Depression, Anxiety, Schizophrenia and rare disease in CNS. In addition, SPRIM Health has experience with rater training and eClinROs as well as ePRO for monitoring suicidal ideation and behavior optimally.