Project management is a continuous loop of planning what to do, checking on progress, comparing progress to plan, taking corrective action if needed, and re-planning. The fundamental items to plan, monitor, and control are time, cost, and performance so that the project stays on schedule, does not exceed its budget, and meets its specifications. Of course all of these activities are based on having an agreed upon Work Breakdown Structure (tasks/activities) on which to base the schedule and cost estimates. During the planning phase of a project, the project manager with the assistance of the project team needs to define the process and procedures that will be used during the implementation phase to monitor and control the project’s performance.
Productivity in the pharmaceutical/biotech/medical device industry is going down. Some compounds have reached the billions expenditures cost without any guarantee that it will ever be approved or reach the market. So how can we evaluate the performance of some of these clinical trials?
I will not go into details in the degree of project management activities managed and performed by a data manager since this can vary widely per company. A good clinical data manager or manager of data management should be able to implement basic PM principles that will improve quality and timeliness of a clinical trial, regardless if the trial is fully outsourced (e.g. CRO performed most of the work).
You can find my article about the Role of Project Management in Clinical Data Management (2012) here for further reading.
So what is Estimate at Completion or EAC? or What is the project likely to cost?
There are several methods we could use to calculate EAC.
Let’s look at one formula. EAC = AC (Actual Cost) + ETC (Estimate to Complete) so what happens when you don’t know the ETC?
We could use the following formula to derive that value: ETC = (BAC – EV) / CPI =>>>>??? So what? More formulas? How do I get BAC or EV or CPI?
Let’s look at those in more details.
| BAC =>>>Budget at Completion (how much did you
budget for the total project?)
|CPI =>>> Cost Performance Index (CPI): BCWP/ACWP|
EV = Earned Value
Earned Value Analysis example for a phase 1 trial (*figures in the thousands / millions = fictitious numbers)
The final clinical trial results includes 100 subjects. The estimated cost is $20 per subject. That results in an estimated budget of $2000 (100 x 20). During the planning, the CRO indicated that would be able to enroll 5 subjects per week. Therefore the estimated duration of the trial is 20 weeks (100 / 5)
EV blocks: From the project plan
Estimated Budget: $2000
Estimated Schedule: 20 weeks
Planned Value (PV): at the end of the trial is $2000
Variance between planned and actual at the end of the first week:
Based on the estimated scheduled, I should have 25 subjects enrolled. At $20 per subject, the planned value at the end of the week is $500 (25 x 20)
PV = $500
At the end of the first week, the CRO reports that he has enrolled 20 subjects and the actual cost of that study is $450. With this information we can look at schedule and cost variance.
SV = EV – PV
SV = $400 – $500 = – 100 ($100 work of subject recruitment is behind schedule).
CV = EV – AC
CV = $400 – $450 = -50 ($50 work of the project is over budget)
*negative figures means bad.
Using early results to predict later results:
Schedule Performance Index (SPI)
SPI = EV/PV
SPI = 400/500 = .80
Cost Performance Index (CPI)
CPI = EV/AC
CPI = 400/450 = .89 –> over budget or expending more
These rations can be used to estimate performance of the project to completion based on the early actual experience.
Estimate to Completion (ETC)
ETC= (PV at completion) – EV)/CPI
ETC= (2000 – 400)/CPI
ETC = (1600/.89) =$ 1798 from end of week one (after 5 days) and it will take additional $1798 to complete the study
Estimate at Completion (EAC)
EAC = AC + ETC
EAC = 450 + 1798 = $2248
If nothing changes, based on the actual results at the end of the first week, the study is estimated to cost $2248 (rather than the planned cost of $2000) and will take 20 percent longer.
The formulas assumes that the accumulative performance reflected in the CPI is likely to continue for the duration of the project.
You do not need to memorize all of these formulas. There are plenty of tools in the industry that does the computation for you. But if you do not have it available, you can use Excel, set-up your template and plug in the numbers.
As per PMI – PMBOK definition, Cost management “…includes the processes involved in estimating, budgeting, and controlling costs so that the project can be completed within the approved budget.” A Guide to the Project Management Body of Knowledge (PMBOK® Guide).
We have shown you, that PM tools such as Earned Value Analysis, can be applied to clinical trials or specific work break down (WBS) activities within the data management team.
Based on the above outcome of the project performance related to the schedule, the data manager should be able to determine if she should modify the current plan or revise the original plan.
It is a perfect tool for data managers and managers of data managers and could be part of your risk based processes.
If bringing efficiency, improving data quality and significantly reducing programming time after implementing CDISC standards is on your radar screen, I’d love to chat when it’s convenient. All the best.
Anayansi Van Der Berg has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical. SAS, CDASH/SDTM (CDISC standards implementation and mapping), SAS QC checks and clinical data reporting.
A Guide to the Project Management Body of Knowledge (PMBOK® Guide).
Notes from my PM class at Keller 2007-2009
Images – Google images
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