Key Performance Metrics Matter - How to measure success in clinical trials

July 18, 2017


 Key Performance Metrics, short KPI, are the bread and butter for every successful business and should be component of every Clinical Trial Project Plan. 


KPIs help you to understand the recruitment process better - from reaching out to potential subjects, via screening to the final visit and wrapping up the study. KPIs help you to identify strength and weaknesses of your trial, like where you should allocate your resources, both in terms of time and manpower, where you can improve a process, or where you should establish benchmarks. On top, KPIs can help you to strengthen the relationship with your sponsor and can even give you a competitive advantage. 


What KPIs should I track? 


To track operational performance, there are many different options. From CitrusLabs experience, we believe that the following for metrics are great to begin with: 


1. Time from "Open for Enrollment" until "Enrollment Quota met"


This KPI is measuring the days from Start of Recruitment until End of Recruitment, or the moment you hit your enrollment quota. 


Why should I care about this KPI? 


The shorter this KPI is, the better for your organisation AND the more happy your sponsor will be. As you know, a large amount of clinical trials are delayed because of patient recruitment. Longer cycles, or even delays in patient recruitment can indicate that you need to improve your recruitment process. 


If your site’s performance for this KPI is good, e.g. your enrollment quota is met on time, or even better, earlier, then you can leverage this in negotiations with the Sponsor. From CitrusLabs experience, Sites with a shorter timeframe from “Open to Enrollment” until “Enrollment Quota met” are more likely to get selected first for future trials with the Sponsor.



2. Cost per Enrolled Subject


Specifically sites with a tough budget will agree that Cost per Enrolled Subjects should always be a key KPI. The important thing to remember is that Cost are always linked with the Efficiency of the Recruitment method. A recruitment channel, who looks at first sight more expensive can turn out to be more efficient and therefore also more cost-effect than a “cheaper” option.


Why should I care about this KPI?


Staying in budget and choosing the most cost-efficient recruitment method is important in order to stay competitive and profitable.


For example, CRO X uses outreach via a local Newspaper Ad for $250 per week. Per month, this is $1,000. Typically response rates from Newspaper Ads are not high, and CRO X gets on average 30 potential subjects per month. This is more than $30 per referral, and these potential subjects are not pre-qualified. 70% of the people that came back to CRO X are not eligible for the trial, which reduces the number of patients to 9 and the cost to more than $100 per subject. Due to this, the trial is delayed, and plays back to the first KPI. The Sponsor is not satisfied and this specific CRO X will not be the first choice of the Sponsor for a next trial.


CRO Y decided to engage CitrusLabs for recruiting, who charged a performance-based fee per referral. This looked at first sight higher than the Newspaper Ad version, but paid off: recruitment was a lot faster. In fact, the CRO was even able to meet the enrollment quota before the official deadline. On top, through CitrusLabs’ pre-qualification process of potential subjects, the error rate in recruitment was a lot lower. As a result, the Sponsor was very satisfied and will re-engage CRO Y without hesitation again.

As you can see from these examples, Cost is strongly tied to effectiveness and also time of recruitment.



3. Time from IRB Submit to IRB Approval


The days from submitting the trial protocol, until it is approved can be a key metrics for your as well. Sometimes, IRB approval can be painfully slow and seems to delay the whole endeavour of conducting a trial.


Why you should I care about this KPI?


When your site is experiencing delays in IRB approval, it is a sign that your submissions lack information the IRB cares about. Sometimes this is a small detail, which can be corrected or added very quickly, sometimes problems are a bit more complex.


You should talk to your IRB about the delays and find solutions to approve new trials faster. As you know, IRB approval is usually one of the first milestones in the life cycle of a clinical trial. Use your good track records to your advantage and promote your Site accordingly.



4. Trial Retention


Retention refers to how many people you can actually retain over the course of the trial. This is a problem almost every trial faces. On average 30% of participants drop out over the course of a trial.


Why should I care about this KPI?


While some drop-outs are unfortunately uncontrollable, and just natural, others are 100% preventable!

85% of clinical trials fail to retain enough patients! This number is shocking! In order to “wow” the Sponsor and other Collaborators you’re working with, you absolutely want to stay in the 15% of trials who retain enough patients!


You have to start thinking like your Clinical Trial Subject! What are they fears? Did you communicate everything well? Is the location convenient? Are there financial constraints? Are there conflicts in the schedule?


Solutions like CitrusLab can help your CRO to be in the 15% of trials who retain enough patients! Through our engaging app, we gamify reminders, visit appointments and give your subjects engaging content around your trial and why they should continue with it!


CitrusLabs is a next generation clinical trial recruitment company that uses mobile data to match and pre-qualify subjects to your trial. We use a highly analytical and quantifiable approach to recruiting, and leave errors and mistakes to a minimum. At the same time, CitrusLabs puts emphasize on Retention. If our approach can assist you in increasing clinical trial participation AND subject retention, schedule a demo!


What KPIs are you setting for your trials? - Write to us.




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