Metrics and Earned Value in Clinical Research

Companies “… measure too much or too little, or the wrong things, and they don’t use their metrics effectively.”

Michael Hammer

It is tempting to measure what is easy rather than what is relevant and important, so it is essential to critically review what you are measuring and why you are measuring it. It is also important to realise that metrics can have both a positive and a negative effect on people’s behaviour, and it is a good idea to get agreement that what you are measuring is fair and reasonable.

The starting point of defining a metric is establishing what you mean by project success, e.g.

       Meeting pre-defined time, cost and quality

       Stakeholder satisfaction




       End User


       Sponsor/Supplier relationship

       Other self-defined criteria

Having defined what success looks like then you need to develop a set of metrics to measure progress and confirm acceptability.

Metrics can be ‘leading’ or ‘lagging’.

Leading metrics enable you to forecast and influence the direction of project progress e.g. current patient recruitment can be behind the plan, on the plan, or exceeding the plan, and the project manager can take the required action to eliminate the risk or exploit the opportunity. 

A metric like patient recruitment is a signpost as to what we might expect in the future, and if that signpost does not point in the right direction, it is up to the project manager to decide what action, if any, needs to be taken. The most effective leading metrics should give you early warning of deviation from your plan.

Early warning is important because interventions are more effective and less costly at the beginning of a project. It is also important to note that deviation from your plan, whether it is positive or negative, can be a threat. Lag metrics are more about analysis of the past e.g. the time it took to initiate a site will not provide you with useful information for completing this project, but it may be useful information for future projects.

A more challenging form of metric are those associated with behaviors, hopefully we can discuss these and come up with some useful examples.

Without doubt the most useful metrics for a project manager are those that will give him or her early warning of deviation from the project plan. A typical leading metric is patient recruitment, but if you want to measure progress for the project from start to finish then  Earned Value (EV), will give you that holistic capability.

The simplest way to think of EV is to equate it to what has been delivered. The methodology that will be demonstrated during the upcoming session counts these deliverables and by using weighted means calculates the percent complete for the whole project. The session will spend some time on defining deliverables, and the planned baseline so that we can measure the EV against the budget and the timeline.

EV measures progress and has four main attributes:

  1. It is a measurement of progress based on deliverables which is independent of the cost or time taken
  2.  It provides early warning of deviation from both the budget and the schedule
  3. It enables you to forecast both project end dates and final costs
  4. The data can be shown in easily understood graphics

Metric and Key Performance Indicators (KPI) are often confused. The definition of a KPI is in the name, firstly it needs to be Key i.e., linked to our measures of success, secondly it needs to be a measure of performance, and thirdly it needs to be an indicator of the future.

EV provides all of these and is the ultimate KPI.




Published on Nov 30, 2022 by Andrea James