Case Study on anxiety disorders
Geography: N/A
Type Service: N/A
Background/Client Requirement:
A global pharmaceutical innovation company with a strong history of successful product commercialization and alliance partnerships, outsourced Techsol Lifesciences to conduct comparative study to evaluate the Efficacy, Safety and Pharmacokinetics of two drugs for the treatment of mild to moderate anxiety disorders.
Project Objectives:
The aim was to assess the Generalized Anxiety Disorder Scale (GAD-7) scores at the end of the treatment Visit 9 (Week 11) compared to baseline for assessing mild to moderate anxiety disorders. The change in Clinical Global Impression-Improvement (CGI-I), Clinical Global Impression – Severity (CGI-S), Patient´s Health Questionnaire-9 (PHQ-9) and Pittsburgh Sleep Quality Index (PSQI) scores at end of the treatment visit 9 (Week 11) were compared to baseline.
Challenges:
- Complexity in SAP Design: Crafting the Statistical Analysis Plan (SAP) to accurately capture changes in GAD-7 scores was challenging. The SAP needed to be meticulously structured to align with the study objectives, including baseline comparisons and endpoint analyses, while accounting for diverse patient demographics and clinical variables.
- Mock Shell Accuracy and Alignment: Developing mock shells that accurately represented the expected output for scale scores data was another critical hurdle. These mock shells needed to account for the various score distributions and outcomes, ensuring consistency with the SAP requirements. Discrepancies between the SAP and the mock shells occasionally led to misalignment of the reporting structure, which necessitates additional time for revisions and validation.
- Data Variability and Interpretability: Mock shells also had to capture the range of possible data variability and ensure clarity in interpreting scores for mild to moderate anxiety over time. Given the variability in patient responses to treatment, establishing consistent reporting across study visits was essential to prevent misinterpretation or loss of crucial data trends.
Techsol Solution/Approach:
- Techsol’s collaborative approach with statisticians, clinicians, and data managers ensures that SAP effectively captures primary and secondary endpoints, while meeting both regulatory and clinical requirements.
- Creating mock shells in stages, incorporating regular feedback loops from data managers and analysts. This iterative process ensured alignment and accurately reflected the SAP specifications. Version-controlled templates allow easier tracking of changes and facilitate faster resolution of misalignments.
- A strong emphasis was placed on ensuring consistency between the SAP and mock shells throughout the project.
- Techsol developed a library of standardized mock shell templates tailored to common anxiety disorder measures, such as GAD-7. These templates include pre-set layouts for reporting scores, baseline comparisons, and patient demographics, reducing setup time and ensuring uniformity across analyses.
- Weekly review meetings were conducted to address SAP and mock shell issues promptly. This enabled the team to identify and resolve misalignments swiftly, fostering effective communication and minimizing delays.
Project Achievements:
- The study achieved significant milestones in assessing the effectiveness of the GAD-7 for tracking treatment progress in mild to moderate anxiety disorders.
- A well-structured SAP was created and implemented. The SAP incorporated methods to account for various demographic and clinical variables, improving the robustness of the analysis.
- Techsol team developed detailed mock shells that accurately reflected the SAP’s data output requirements, ensuring clarity and consistency in data reporting.
- Through the use of automated validation tools, data normalization techniques, and error-checking software, the project achieved high standards of data quality. These measures minimized variability and ensured accurate reflection of changes in anxiety symptoms, providing reliable results.
- The study provided clinicians with valuable insights into GAD-7 score changes, demonstrating the scale’s utility in assessing treatment outcomes. Data visualizations and standardized score thresholds facilitated easier interpretation, supporting clinical decision-making.
The Outcome:
This project successfully validated the primary scales as reliable tools for monitoring treatment progress in patients with mild to moderate anxiety disorders, showcasing the effectiveness of scales in monitoring symptoms changes from baseline through Visit 9 (Week 11). Specifically, the GAD-7 scale effectively captured symptoms change over time, with significant reduction in anxiety levels observed by the study’s endpoint.
A sensitivity analysis was conducted to evaluate the stability of the findings under various analytical assumptions. This analysis confirmed that the outcomes remained consistent across different scenarios.