What is risk management in
clinical trials?
Risk
management in clinical trials is a systematic approach to ensure expected safety
and quality standards are maintained at each stage of the clinical trials
process. It means identify, assess, control, communicate and review the risks
associated with the entire lifecycle of clinical trial. This helps to achieve
more informed decision making as well as better resource utilisation. All the
stakeholders are responsible to contribute to the delivery of an effective
risk-based quality management system. The entire risk management process should
be carefully documented and integrated into the existing quality systems of the
clinical trials.
Why is risk management important in clinical
trials?
Risk management is
becoming an increasingly important topic in clinical research. Though clinical
trials are dangerous but they are very important for the development of new
drugs and treatment. As compared to traditional monitoring practices,
risk-based monitoring offers the following advantages:
·
Increased safety of
patients
·
Efficient and
effective protocol design
·
Reduced costs of
clinical trials
·
Integrity of data
There is an enhanced
pressure from regulators to adopt risk-based monitoring for effective
identification and mitigation of risks. According to the PricewaterhouseCoopers
(PwC) report on Risk-based monitoring:
Reduce clinical trial costs while protecting safety and quality, risk
management helps to reduce clinical trials costs by almost 15-20%.
What are the sources of risk
identified in clinical trials process?
Some of the sources of
risks identified in clinical trials are as follows:
·
Ill-defined study
protocol
·
Mid-study changes and
amendments
·
Lack of qualified and
experienced staff
·
Inadequately
maintained medical records of the personnel
·
Delays in personnel
recruitment
·
Informed consent
·
Confidentiality and
protection of patients
·
Protocol deviations
like inclusion/exclusion criteria, procedural deviations and enforcement of
rules
·
Site accountability
·
Proper assignment of
drug
·
Site issues like
patient attrition and data quality etc.
What are the various stages of
risk management in clinical trials?
1. Risk assessment – Gathering
knowledge of what are the key factors for establishing priorities and
identifying risks. Understanding what negative outcomes are possible and what
are their impact as well as probability of occurrence.
2. Risk control – Brainstorming
and taking decisions that help define how to mitigate risks and establish a
sound risk management plan followed by implementation of the plan.
3. Risk review: On-going
assessment of the risks in terms of new information appearing during the
clinical trials’ conduct and output of trial management activities. Impact of
the risk management plan and tolerance limit is evaluated.
4. Risk management: Using
paper-based or technological advances like e-mail, webcasts, online training
modules etc. to detect, identify, predict, track, analyse risk.
5. Risk communication: Sharing
the risk review documents with all the stakeholders and decision makers.
Accurately and timely communication of risk mitigation and acceptance measures.
Risk-based management
practices like centralized monitoring and reliance on technological advances helps
to meet statutory and regulatory requirements. As cited in the Reflection paper
on risk based quality management in clinical trials by European Medicine Agency
(EMA), by giving due regards to the risk involved in critical data elements and
processes necessary to achieve study objectives, risk-based monitoring gives
allows for better subject protection and overall study quality as compared to
the routine clinical sites visit and 100% data verification.
What are the key aspects of a
successful risk-based management?
A
successful risk-based management is based on an integrated approach to risk
assessment and monitoring throughout the lifecycle of clinical trials. Some key
aspects are:
·
Early
planning
·
Analytical
expertise’
·
Sophisticated
tools
·
Process
adaptability
·
Cross-functional
expertise
·
Collaboration
·
Communication
of risks and mitigation measures
·
Flexibility
to adopt risk-mitigation plans
Contract research organisation
(CROs) and the sponsors which possess solid core capabilities of risk-based
management plans during the lifecycle of clinical trials stand to emerge winner
in the clinical trials landscape.
