Risk assessment and management in clinical trials

With the  increased in  clinical R&D and a budgetary constraints in the complexities of a clinical development,a risk management has become an essential and integral piece to a clinical trial management to ensure the good return on the investment. The core of a risk management is a identification and  assessment of a risks in the beginning and  it is also continuous basis for a risk-bearing activities in clinical trial. After issuance of a guidance on a Risk-Based Monitoring by FDA, the sponsors/CROs have demonstrated a keen interest in adopting a systematic approach to a risk assessment in clinical trials.

Risk assessment is a systematic process for identifying and evaluating events that could be affect the achievement of the clinical study objectives.These documents include FDA’s “Guidance for Industry: Oversight of a Clinical Investigations—A Risk-Based Approach is to Monitoring” and EMA’s “Reflection paper on risk based quality management in the clinical trials”. The focus of the regulators on this concept initiates a discussion of how to introduce and implement, to apply risk management principles to the clinical trials. The applicable guidances for the good clinical practice (GCP), ICH E6 and ISO14155, it state explicitly that the sponsor is responsible for quality assurance and quality control.Risk management concepts can be extracted from  ISO 14971: Risk Management for Medical Devices and ICH Q9: Quality Risk Management. The first step is to define a procedure for conducting this activity. The basic steps for risk management include:the identify and assess risks, mitigate risks, and review risks. Additional steps that are required throughout the process include a communication of risks and a documentation activities

  • 14.1 Identify and Assess Risks
  • 14.2 Mitigate Risks
  • 14.3 Communicate and Document Risks
  • 14.4 Assess the root causes risks and tolerance limits
  • 14.5 Assess the likelihood and impact of the risks

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