Implementation methodology of the Risk Management in Clinical Projects requires coordination and integration of the information from several relevant sources. In the past it was believed that the ‘stratified approach’ to the categorization of the clinical trial risks is sufficient. However, the current prevailing opinion on the topic, suggests that a more ‘trial specific’ approach to the risk assessment is required [1]. Such ‘trial specific’ approach, in the trial design and planning phase is most effectively applied through the structured approach to protocol development.
If we look at the ICH E6 (R2) recommendations [2] to the risk-based approach to quality, we can identify 7 key steps to be implemented:
- Critical Process and Data Identification
- Risk Identification
- Risk Evaluation
- Risk Control
- Risk Communication
- Risk Review
- Risk Reporting
Those 7 key steps, should be implemented holistically within the Clinical Development, suggesting a structured, even perhaps hierarchical organization and management of the development risks, in order to provide taxonomy of risks as suggested by TransCelerate [3].
Risk Management in Clinical Projects and Trials Starts with Protocol Design
For those research organizations, that use a structured approach to trial planning and design, implementation of the ‘trial specific’ approach to the Risk Management comes naturally. Even more so, if they approach the clinical trial planning and design from the clinical project level (including alignment with Target Product Profile (TPP)). Such research organizations start the Risk-Based Quality Management from the protocol design phase.
With a structured clinical protocol, it becomes possible to identify, categorize and assess the risk on a clinical project level and refer to it in all clinical trials that are using these particular design elements. In this case the risk based approaches is established at the clinical project (clinical program) level and then re-used (protocol by protocol) throughout clinical development, building on the experience achieved with each study and general technical, regulatory and other advances made during the time period of the clinical project, as suggested by the EMA reflection paper [1].
Using such structured approach to risk management in clinical projects, research organizations can build their specific ‘risk libraries’ that are well defined and managed for:
- protocol complexity
- subject population
- therapeutic indication
- endpoints
- study procedures, activities and measurements
Thereby, focusing on significant emerging risks, instead of re-discussing ‘already known’ risks that have been well defined, assessed and mitigated in the previous trials.
Risk Library (Repository) for Clinical Development
Risk Library (Repository) defines and stores the risks to which Clinical Development Organization is exposed. All risks are defined within the library for the purpose of facilitating discussions on the risks and their definitions, their applicability, consistency and it promotes the culture of risk awareness and Quality by Design (QbD) principles and risk management in clinical projects.
For those research organizations that are already managing their standards and meta-data within a true ISO/IEC 11179 compliant Meta-Data Repository (MDR), the implementation of the Risk Library could simply be an extension of their existing MDR solution. This way, the utilization of the MDR solution is raised to a new level, where the MDR is not only used for storage and management of clinical data standards, but also for integrated management of clinical development risks. Using such approach it would be possible to link not only clinical data standards End-To-End but also the associated risks.
Structured Approach to
Risk Management in Clinical Projects
intilaris is helping Pharma Clients to optimize their Clinical Development through Structured Approach to:
- Target Product Profile
- Clinical Development Plan
- Clinical Study Protocols
- Risk Management in Clinical Development
- Streamlined Clinical Operations
- Standards Repository (MDR) Implementation
- End-To-End Standardization
Please reach out to us for an independent and expert consultation on those topics.
[2] ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6 (R2) Integrated Addendum, November 2016.
[3] QMS Risk Management Risk Library – Version 1 – 18JUN2018.
