Psychiatry
Our team is adept at ensuring data quality in these complex scenarios, utilizing expert psychiatric evaluators and advanced data capture technologies.
Mental health clinical trials pose challenges from multiple perspectives. A CRO must ensure that it has the requisite skills to allow recruitment of the correct population, minimize placebo effects, standardize (subjective) rating scales, and ensure patient safety.
Our expertise extends to various conditions, including:
We help design studies that consider the unique nature of psychiatric assessments, which often rely on patient-reported outcomes and observer ratings. Strategies to minimize placebo effect and neurobehavioral biases are always built into all our mental health trials.
Our team is adept at ensuring data quality in these complex scenarios, utilizing expert psychiatric evaluators and advanced data capture technologies.
Our expertise extends to various conditions, including:
We help design studies that consider the unique nature of psychiatric assessments, which often rely on patient-reported outcomes and observer ratings. Strategies to minimize placebo effect and neurobehavioral biases are always built into all our mental health trials.
Pain points associated with clinical trials in psychiatry
- Subjectivity of Assessments: Many psychiatric symptoms are self-reported, leading to potential biases and variability in data.
- Heterogeneity of Disorders: There's often a wide range of symptoms within a single diagnosis, which can make it hard to ascertain treatment effects for a broad population.
- Placebo Effect: Psychiatric trials often have a strong placebo response, making it difficult to demonstrate the efficacy of the investigational treatment.
- Recruitment Challenges: It can be challenging to recruit and retain participants for psychiatric studies due to stigma, severity of illness, or concerns about novel treatments.
- Ethical Concerns: Balancing the potential risks and benefits, especially in vulnerable populations or with novel treatments, can be challenging.
How iNGENū addresses these pain points
- Objective Biomarkers: One of our flagship initiatives involves advancing the quest for objective biomarkers. Recognizing the challenges of subjective assessments, iNGENū is collaborating with experts to develop and implement imaging techniques and blood tests that promise a more objective measure for psychiatric disorders and treatment responses.
- Stratified and Personalized Medicine: Recognizing that not all patients with the same diagnosis are alike, we aim to pinpoint patient profiles and specific subtypes of disorders, enabling the development of tailored therapeutic interventions that yield better outcomes.
- Adaptive Trial Designs: We are actively promoting and utilizing adaptive trial designs. By allowing for real-time modifications based on emerging results, these trials are not only more efficient but also have the potential to be more patient-centric, addressing the challenges of the strong placebo effects often seen in psychiatric research.
- Patient Engagement: iNGENū collaborates closely with patient groups to ensure that trials are designed with the patients' needs and concerns at the forefront, thereby enhancing recruitment and retention rates.