Risk management in Clinical Trials

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.

Ensure International Quality Standard Clinical Trial With Global Good Clinical Practice Guidelines

Good Clinical Practices (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

These practices aim to ensure the public that the conducted studies are authentic and the clinical properties of the investigatory product are properly documented, and the rights and safety of the trial subjects are protected. This will also assure the international credibility of the trials and its data. Stricter good clinical practice guidelines make sure that higher standard are followed in terms of comprehensive documentation for the clinical rules, record keeping, auditing, training, facilities and other similar aspects.

In fact, these guidelines are there to ensure unification of standards on how clinical trials should be conducted, how and what roles and responsibilities of the clinical trial sponsors are, and similar other facets, for global/international recognition. Further, these guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds in the laboratory.

So, a better understanding of good clinical practice and its guidelines is required by all individuals involved in clinical trials and research. Various training courses are also offered by institutes, all across the world. The only need is to get started with them! The worst to happen in any trial is to discover any non-conformity during regulatory authority submission. All the past efforts will be render wasted. Take no risk and make sure that the trial is following to Good Clinical Practices.

Thus, start conducting your search today and find the best training firm today to ensure your trial credibility!