Case Study Oncology (Breast Cancer)
Geography: N/A
Type Service: N/A
Background/Client Requirement:
A leading global pharma healthcare provider, driven by the purpose of delivering care and nurturance to patients, empowered by innovation and science has collaborated with Techsol Lifesciences to execute Technical & Data management activities for clinical evaluations of new oncology therapeutic drug. This Phase III study focuses on previously untreated patients with Human Epidermal Growth Factor Receptor 2 (HER2) positive metastatic breast cancer (MBC), ensuring compliance with regulatory authorities.
Project Objectives:
The aim for this clinical study was to develop and uphold essential procedures including Case Report Form (CRF) designing, CRF annotation, database design, data entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality data at regular intervals during a trial.
The primary objective is to generate high-quality, reliable, and statistically sound data from clinical trials. This involves the delivery of clean quality clinical trial databases, with CDISC complaint, along with datasets and reports for easy review of clinical data for Clinical Data Management team.
Challenges:
- Design challenges: Sponsors clinical team has challenges in designing the Case Report Forms for Oncology studies due to its complexity of the study requirements and the treatment involved in the study.
- Data Validation challenges: Preparation of Data Validation Plan (Edit checks) was a great challenge due to its complexity of the study requirements and the treatment involved in the study. Due to the EDC system limitation and also due to complexity of the data points collected in the case report forms validating site collected data using system programs were not possible.
- Data review challenges: Multiple local labs with wide variety of lab test ranges across sites made the data review process more complex. and frequent changes in lab ranges by sponsor was a big challenge on reviewed data in identifying relevant insights in short time. AE relevant medication review process was tedious due to high volume of medication involved in treatment of adverse events.
- Data Quality challenges: Ensuring the quality and reliability of the study data was crucial as it was very difficult with high volume of data, and frequent updates on data by site persons in Electronic Data Capture Application (EDC) on Data Manager reviewed data.
Techsol Solution/Approach:
- With extensive experience in conduction clinical trials, our CDM team and Medical Experts at Techsol have created a global library of Case Reports Forms (CRFs) for all major therapeutic areas. This library helped us to develop a CRF that meets sponsor study requirements and also captures critical and non-critical data points.
- Our Clinical data managers has developed a comprehensive data validation plan to validate all the critical and non-critical data points. This includes the implementation of both programmed and manual edit checks to address complex study data validation scenarios.
- Our study programmers have developed out of box solution using SAS programming to validate data for all the manual edit checks
- Techsol has developed standard data review guidelines for this complex study to review all the lab data that is collect across the sites with multiple lab ranges. The CDM team is well-trained on this review guidelines.
- Our Safety and Monitoring Review Board conducts weekly meetings with key stakeholders to review SAE and AE-related data. They also assist the CDM team in reconciling safety data across systems.
- Techsol has implemented a comprehensive clinical data review process by establishing a QC review board, comprised of medical experts, lead data managers and quality control team and also created a quality review process, ensuring comprehensive and accurate clinical data review.
Project Achievements:
- Clinical Trial Success: The study successfully demonstrated the efficacy and safety of a new treatment, marking a significant achievement.
- End-to-end Clinical Data Review: The team conducted a comprehensive review of all clinical data, coordinating with the sponsor and the Clinical Operations team to ensure data reliability, accuracy, and statistical soundness. This meticulous review enabled precise analysis and reporting.
- On-time delivery of documents and clinical data: Timely delivery of documents and clinical data to Sponsor met all sponsor requirements and achieved critical milestones, ensuring project efficiency.
- Improved Data Quality and Integrity: Rigorous quality control measures, including automated data validation checks and real-time data monitoring, have improved the quality and integrity of clinical trial data. These efforts ensured that collected data were accurate, consistent, and reliable enhancing the credibility of research findings.
- Compliance with Regulatory Standards: Robust clinical data management practices ensure compliance with regulatory standards and guidelines. This helps maintain data integrity, patient confidentiality, and upheld ethical conduct throughout the clinical trial process.
The Outcome:
- Techsol Lifesciences’s highly experienced and qualified team successfully completed the clinical study. Sponsor expressed high satisfaction with our services and best practices.
- Established mechanisms for continuous process improvement in clinical data management practices, including feedback mechanisms, training programs, and lessons learned from trial conduct, to enhance efficiency and effectiveness in future studies.
- This achievement was attributed to the collaboration between experienced resources and the client’s Clinical Operations team. Alliance of Techsol Lifesciences team and Standard Operating Procedures and good clinical practices made this great achievement.
- The clinical trial was conducted in full compliance with regulatory authority requirements, ensuring ethical and data integrity standards were upheld.
- The success of the study generated positive investor sentiment and reinforced confidence in the sponsor’s pipeline and research capabilities, potentially leading to increased investment and support for future projects.