Identification of Risk - Clinical Trials

Potential Risks is an essential part because Clinical Trials projects tend to be time constrained, post huge technical challenges and suffer from adequate resources. Not all the risks are equally important, should focus on risks that can materially affect project objectives or uncertainty that matters. There are numbers of factors can be internal, such as available resources, skills level of human resources, funding availability, management approach, time constraints etc.

Risks also vary depending on the stakeholder: subjects, study team, sponsor, competent authorities, target population and that is why stakeholders education, awareness, engagement and support are critical success factors for project risk management. Organizational and stakeholder risk attitudes and risk tolerances must be explicitly identified and managed before and during the project.

Clinical Trials process may be divided into three main steps, each of these steps can be associated with number of more or less significant risks.

1.Pre Trial: Study concept, Protocol Design, Site selection, clinical trial Agreement signing procedure. From application to competent authorities to first subject enrollment.

2.Conduct Trial: From first subject enrollment to Data base lock, presents risks related to recruitment, non compliance with regulatory aspects, data quality.

3. Post Trial: statistical methodology, impact on target population or public health in general.

Risk Management Process includes Identify Risks, Qualitative risk analysis, Quantitative risk analysis, Risk Monitoring and control.

Identify Risk: Identify all knowable risks to project objectives, including both Threats and Opportunities.Post Project reviews and lesson learned, Assumption and constraints analysis, Checklist analysis, Prompt lists, Root cause analysis, Brainstorming, Delphi Techniques, Force field analysis, Questionnaires.

Qualitative Risk Analysis: Assessing probability (likelihood) and impact if it does occur. Define Priority and Impact. Derive High Prioritized Risks(Priority *Impact)

Quantitative Risk Analysis: Quantifies the possible outcome for the project. Determine which risk events warrants response and overall project risk. Using Monte Carlo Simulation or Latin Hypercube.

Plan Risk Responses: For Positive Risks- Enhance, Exploit, Share and Accept. for Negative Risks- Mitigate, Avoid, Transfer and Accept.

Risk Monitoring and Control: Risk Reassessment-Monitoring risks often results in new Risks. Risk Audit- Effectiveness of risk responses in dealing with their root causes and risk management process.

It is unlikely that you will have all of this information initially. Therefore, the risk identification process is iterative. Each project is different and requires the project manager to determine the appropriate inputs and frequency.

Who identifies the risks? Project managers, team members, internal and external stakeholders, sponsor, to name a few. Notice that the project manager does NOT identify risks by themselves, since they have a limited view of the total project.

Project managers seek to increase the level of project detail through progressive elaboration. The aim is to reduce uncertainty — to uncover what is not known, to clarify assumptions, and to make decisions that propel the project forward. As these activities occur, the understanding of future events and conditions change. Consequently, project managers must update their risk registers.

Pre-mortem. This method can be used before the project begins. The project manager tells a story to the project team, as though the upcoming project has been completed. The story includes details of what transpired with elements of success and challenge, but the project is described ultimately as a failure. The project team is asked to identify risks and how the risks could have been handled to drive success.

Post-mortem. The project manager can facilitate a post review of a project that has truly failed, to identify lessons learned.

Nominal group technique. The project manager identifies a category of risk such as external risks. The team is asked to write down risks for the category. The project manager asks each team member to identify a risk and continues the process until all risks are captured, typically on a white board or cling sheets. Members are asked to rank the risks. The project manager captures the rankings of each member and shares the results. The project manager moves to the next risk category and continues the process. This method minimizes groupthink.

Facilitated workshops. A facilitator, often the project manager, facilitates a structured workshop aimed at identifying risks.

Scenario analysis. Different combinations of significant risks are described. Team members are asked to analyze the dependencies and impact to the project. It is possible to quantify the risks and illustrate which risk categories have the greatest risk exposure.(What if)

Brainstorming. Meeting where team members identify risks. Participants  (including CRAs, MWs, CDMs) are asked to refrain from criticizing ideas.

Interviews. The project manager interviews internal and external stakeholders to identify risks. This method takes a lot of time.

Cause and effect diagrams (i.e., Ishikawa Diagrams or Fishbone Diagrams). This tool can be used to identify the factors that contribute to an effect. For example, the project manager may ask what may be contributing to delays in the schedule. Team members may identify factors such as human resource issues, poor testing, and lack of training.

SWOT analysis. SWOT is an acronym for strengths, weaknesses, opportunities, and threats. The SWOT method is often used for strategic planning, but it may be used for risk identification too. For example, a project manager may facilitate a SWOT session on a business process or system.

HAZOD. HAZOD stands for hazard and operability study, which is a comprehensive analysis of a process or system. The project manager or business analyst facilitates a workshop by first dividing the project or system design into components. The team reviews each component to identify risks, causes of risks, impacts, and responses to risks. (e.g. Investigational Products)

Delphi technique. Involves submitting, at least, two rounds of queries through surveys or questionnaires to selected stakeholders. For example, the first query could involve asking participants to identify risks. The second query could involve having the participants rank the identified risks. This method minimizes groupthink.

Affinity diagrams. This method can help groups to identify the categories of risks. Start by brainstorming risks. Then ask the team to organize the risks into groups such as requirements, design, development, and testing.

Prompt list. Use a generic list of risks to “prompt” team members to identify risks. For example, a project manager may ask team members to identify requirement risks and then design risks.

A prompt list is list of common risk categories that can be used to
framework for additional risk identification techniques. Prompt lists stimulate creative thinking and an excellent tool to use with brainstorming.

Prompt lists are the highest level of risk breakdown structure example
PESTLE (Political, Economic, Social, Technological, Legal, Environmental)
TECOP ( Technical, Environmental, Commercial, Operational, Political),
SPECTRUM (Socio-Cultural, Political, Economic, Competitive, Technology, Regulatory/Legal, Uncertainty, Market).

Example: Economic: Interest rates, currency, financial markets, cash flow. Social: Ethical failures, loss of people, fraud, strikes. Technological: Technology change, Technical processes, system integrity, system availability. Operational: Fire, Natural hazards, patient injury, Investigational Product contamination, Investigational Product recall. Commercial: Internal procurement, suppliers and vendors, customer stability, contractual terms and conditions.

Checklist analysis. The project team uses a list of common risks — developed from previous similar projects — to help identify potential risks for a project. Beware — checklists are not comprehensive. Ask what else may help or hinder your projects.

Failure modes and analysis. This tool helps to identify failure modes, effects of each failure, and ways to reduce the probability and impact of the each failure.

Documentation analysis. The project manager may work with team members to perform a formal review of project documents such as requirement documents, project planning documents, contracts, historical documents, and reports from external entities.

Assumption analysis. The project team digs a little deeper to determine whether assumptions are valid.

Identification of risks is best done part of overall project planning, listing risks as you proceed. Risk management process provide a way to learn whether your project is feasible-whether you should believe it is possible. A feeling of confidence, based on credible information, is a powerful determinant of success and risk information is key source of data.

Thanks
Smit Shah PMP, PMI-RMP