Risk Analysis in Clinical Trials-Overview
What Is Risk Analysis?
Risk Analysis is the process of
determining the significance of risks. The result of the risk evaluation
technique is an update to our risk register showing the priorities of the
risks. Using risk thresholds to determine which risks are urgent and require
treatment.
There are many ways to analyze risks.
We can simply assign a Low, Medium, or High rating for each risk. A better method is to evaluate the probability
(likelihood) and impact (consequence) of each risk, assigning a numeric rating
such as 1 to 5, 5 being the highest. When to Evaluate Risks
Should start evaluating risks early in their projects; should continue evaluating risks in an iterative until the project is completed.
Importance:
Inspection cost us money, but what are
our risks without the inspection? A few years later. Imagine the inconvenience,
the amount of time, and the cost to replace the data/things.There is always a cost of risks, now and later. We have the cost of managing risks such as the time for identifying and evaluating risks. There’s the cost for treating risks — the responses to mitigate threats and exploit opportunities. And there’s the cost of responding to issues (events that have occurred such as the termites that have destroyed your floor).
Risk Analysis involves Qualitative and
Quantitative risk analysis. Qualitative analysis involves simple methods
for quickly rating and prioritizing your risks. Quantitative analysis is
a numeric analysis that requires more time but provides more data to aid in
making decisions.
Qualitative Risk Analysis
1. KISS (Keep It Super Simple) Method,
2. Stacked Ranking Method
3. Probability/Impact Method
1. KISS (Keep It Super Simple) Method
KISS (Keep It Super Simple) Method on
small initiatives and projects and with teams that lack maturity in assessing
risks. This one-dimensional technique involves rating risks as:Very Low, Low, Medium, High, Very High
2. Stacked Ranking
Method
The Stacked Ranking Method is quick,
simple, and is a great method to use with teams. First, the team identifies and
captures the risks on Post It Notes that are placed on the wall randomly.
Second, the facilitator asks the team, “Which risk is greatest?” The
facilitator places the risk in a space on the wall by itself.
The facilitator continues, “What is
the next highest risk?” and places the selected risk under the first. The
process continues until all the risks have been placed in rank order. If you
like, you can write a number on each Post It Note to indicate the order (e.g.,
1 on the top risk, 2 on the second highest risk, etc.).
3.
Probability/Impact Method
This two-dimensional technique is used
to rate probability and impact and may be used to evaluate enterprise,
department, and project risks. Probability is the likelihood that a risk will
occur. Impact is the consequence or effect of the risk, normally associated
with impact to schedule, cost, scope, and quality. Rate probability and impact
using a scale such as 1 to 5.
Once you have rated each risk,
calculate the risk score as follows:
Probability x Impact = Risk Score
Risks for Conduction of Clinical Trials in Oncology Indication
1) Subject Enrollment- Probability is 5 and Impact would be 3
2) Subject Retention- Probability is 4 and Impact would be 5
Example:
Patient Enrollment: 5 x 3 = 15
Patient Retention: 4 x 5 = 20
Sort the risks in descending order with
the risk score as the primary sort. in this case Subject Retention would be the highest risk for this Clinical Trial.Patient Enrollment: 5 x 3 = 15
Patient Retention: 4 x 5 = 20
Quantitative Risk Analysis
High temperature describes your
temperature in qualitative terms. If it says temperature is 104 degrees
Fahrenheit, then it is quantitatively terms.
Example: There is a 30% chance that site
will be 10 days late in enrolling the subjects.”
While qualitative analysis takes less
time, it is subjective. Quantitative analysis requires more time and effort,
but it provides more detailed information.
When to Perform
Quantitative Risk Analysis
The example above illustrates a case
of when quantitative risks analysis was needed — it allowed the project sponsor
to make a more informed decision than was possible with the qualitative risk
analysis. The quantitative analysis also allowed the project manager to make
better decisions about which risks merited a response.
For large, complex projects, project
managers may create contingency and management reserves for their schedule and
their budget. The quantitative risk analysis allows the project managers to
demonstrate and justify the need for the reserves.
Analyzing the
Highest Risks with Examples
The team rated these six risks
quantitatively as follows:
Risk A. There is a 30% probability
that the training time will require an additional 10 days.
Risk B. There is a 40% probability of
adding an additional quality assurance member and decrease internal audit time
by 20 days.
Risk C. There is a 50% probability
that the Electronic Data Capture vendor will implement a required upgrade that
will require an additional 20 days.
Risk D. There is 30% probability of
the stakeholders asking for additional software features that will require an
additional 30 days.
Risk E. There is a 25% probability
that the Protocol design will be able to leverage another set of code that will
reduce the coding time by 20 days.
Risk F. There is a 70% probability the
stress testing will result in the need for an additional database work that
will require an additional 40 days.
Notice that Risks B and E are opportunities
while rest are Threats.
Expected Monetary
Value (EMV) to calculate the
contingency reserves which account for the unknown amount of rework. For those
of you who may hate math, it does not get any easier than this.
EMV = Probability
x Impact.
Should add total of 37 days of
contingency reserves to the schedule for “known-unknowns”. If desired, we may
also add management reserves intended to address “unknown-unknowns”.
Quantitative
Tools and Techniques
Quantitative risk analysis tools and
techniques include but are not limited to:
I.
EMV is a statistical concept that allows project
managers to calculate the average outcome when the future includes scenarios
that may or may not happen. (Although the EMV sounds complex, it’s not
difficult to perform.)
II.
Three-point
estimate used to determine the expected result
using three estimates: pessimistic, optimistic, and most likely. Expected value
= (Pessimistic + 4 (Most Likely) + Optimistic) / 6.
III.
Modeling and
simulation- some project managers use the Monte
Carlo technique to perform simulations of the project uncertainties.
IV.
Sensitivity
analysis-this technique helps to determine
which risks have the most potential impact on the project objectives.
V.
Decisions
tree used when choosing among different
options. Considers future events and aids in making decisions by taking into
account risks, probabilities, and impacts.
Putting the
Pieces Together
Should always use qualitative risk analysis — it’s quick and can save lots of time and
money which allows team to prioritize
their risks quickly and determine which risks merit attention.
The quantitative risk analysis is not
always required. When you need more detailed information for large complex projects,
pick and perform appropriate quantitative techniques. The quantitative analysis
will require more time than the qualitative analysis. It will help you make
more informed decisions.
"If you do not actively attack
the risks, they will actively attack you." --Tom Gib
Read here more on Identification of Risks- Clinical Trials
Read here more on Identification of Risks- Clinical Trials
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