Title : Development and Evaluation of Structured Strategic Approach for successful accomplishment of Risk-Based Monitoring model from clinical trial inception to completion at clinical trial organization.
Abstract:
International Conference on Harmonization guideline E6 requires clinical trial sponsors to conduct monitoring oversight to ensure the protection of rights, safety and welfare of the clinical trial subjects. In 1988, the FDA released a guideline for Monitoring Clinical Investigations. This guideline states that ‘The most effective way to assure the accuracy of the data submitted to the FDA is to review individual subject records and other supporting documents and compare those records with the reports prepared by the investigator for submission to the sponsor. The 1988 guidelines led to a common consent that most of the industry that SDV of up to 100% of all entered data was required to comply with the FDA requirements for data quality and integrity. The guidelines advise the sponsors to generate an adequate level of monitoring, which is inclusive of alternative monitoring methods other than SDV, combined with risk identification and risk mitigation process for the entire duration of the trial. SDV method proves to be costly and accounts for an average of 25% of the entire clinical trial budget. In the past two decades, the industry has seen a tremendous increase in number of global clinical trials and their complexity. These changes create new challenges with respect to clinical trial oversight, differences in clinical investigator experience, site infrastructure, treatment patterns, the standard of healthcare and geographic variance. Additionally, increased use of electronic systems, and improvements in statistical assessments create a pathway for alternative monitoring approaches that can improve the quality and efficient of sponsor oversight. The previously available literature suggests that though we have guidance available from the regulatory agencies the sponsors and CRO are still trying to trace a pathway for successful implementation. This study tries to understand challenges in implementation and possible solutions to these challenges, developing correct and selecting right systems that is compliant to regulatory requirements and is easily adoptable by users. Additionally, the study tries to understand if the adoption of RBM model can be cost-effective compared to traditional monitoring methods and ultimately leads to a reduction of time. 54.6% (279 participants) of respondents believe that RBM model helps reduce the time taken to review the EDC. 45.6% (233 participants) strongly agrees that mindset change is the first step toward RBM implementation. 42.9% (219 participants) agree that new mobile technologies like smartphone and fit bits to collect patient data can become new operational excellence in RBM closely followed by 42.5% (217) participants who strongly agree to this ideology. 51.1% (261 participants) agree that RBM is all about targeted, efficient and intelligent monitoring and e-consenting is an example of intelligent monitoring. 39.1% (200 participants) are of opinion that a mixed SDV strategy helps in the reduction of overall cost and time. 40.9% (209 participants) opine that incorporating RBM in protocol and study design is important for implementing RBM. Implementation of RBM system needs data analytics hence having expertise in IT and clinical operations is paramount. Using a risk-based monitoring technique as an alternative monitoring method reduces the overall cost of the trial. However, risk-based monitoring will not reduce the importance of sponsor representatives visiting the site.
