Metrics, metrics, come get your metrics! Best served hot and fresh…

Partnerships In Clinical Trials 2012 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to this year's event.

Metrics, metrics, come get your metrics! Best served hot and fresh…

Introduction to Metrics

Metrics. The big thing that everyone seems to want these days is metrics and usually a lot of them. They will be able to democratize clinical research and shed a light on what has been in the shadows of gathered data for too long.
Everywhere you go everyone has a bee in their bonnet about not having enough or too much to make sense of. Webster defines metrics as “Standards of measurement by which efficiency, performance, or progress can be measured”. To push this out a bit more, metrics should be easily accessible, readily audit-able and most importantly actionable. Challenges are to take these items and to be able to apply them to improve future performance and/or address past problems.

3 questions to ask on Metrics

Anyone who has spent time in the clinical research knows how much we have all come to depend on metrics. But so often is the case one can get bogged down in to much data flow and how to adequately and efficiently harness this torrent of info. We really should distill it into 3 basic questions:

1. 1. What should we measure?
2. 2. How do we capture the metrics?
3. 3. What do we do with what has been measured?

Well, we sure know what to measure and some examples out of the myriad that can be tracked are;

• - Time to initiate a site
• - Time to complete a trial
• - Time to send contracts/get them back
• - Time for IRB approval
• - Number of contract/budget revisions
• - 1572 revisions
• - Execution of clinical trial agreement
• - # of revisions
• - length of time in sites/sponsors hands
• - Time, time, time, number of, ….

But how often are we really figuring out just how the heck to capture them properly and utilize them to our full advantage? And how often do current CTMS systems measure metrics in the most critical part of the trial, the study start-up (SSU) phase? Answer for both, not often enough if at all. And even more pressing, how much transparency do all involved have during this process? Slim to none at best! In the dark groping around trying to make sense is not the position to be in. (Think of that late night drink of water at grandma’s house. You want to make sure that its the water glass and not the one with her teeth in it…) Especially when most of the time sites and sponsors/CRO need to have the ability to access these metrics in real time. Getting the key documents sent, tracked, and signed off is the heart of the SSU process. Only when all these are in place can the trial start to bring in patients.

I can hear a lot of you saying, “But we capture metrics!”, and I am sure that you do but how many of you capture these in the moment? Over 80% of the industry still uses spreadsheets to convey info to the team members. And sure the one that is entering the data feels like he/she is capturing it in real time, sorry… you’re really not. So the WHEN is already outdated once it is sent out to the team and read by them.

How should Metrics be Captured?

The HOW of metrics are captured is also a critical component in making the most of your metrics. Spreadsheets get very big and cumbersome when you are trying to convey metrics by department, organizations, regionally, by country, across multiple countries and partners. And while this potential kaleidoscope of colors may look real pretty, it takes some time to disseminate the information. How often will this be transparent to all that are on the trial? Not often, someone is always tripping/fumbling in the dark. For the team to work as a cohesive unit and for all to work together to get the trial up and running as rapidly as possible, these metrics must be able to visualized in real-time. Lets face it, while we are in this industry as a business, the goal of all that are involved is to get critical medicine to the vulnerable people that need it. Yesterday in many cases.

Making document exchange communication and management of tasks easier for all involved is the goal of a well made system. To be able to make this simple, efficient and most of transparent is the trifecta. Metrics ultimately is what we all believe will make this happen which is why we all promote them so much. And by giving the teams full transparency to how the study is progressing, where the ball may be being dropped/juggled, and how we can improve the next study will only help to make this part of the trial better and get the study to completion faster.

To learn more about what we do and how we want to help the clinical study startup please contact Leif (lerickson@gobalto.com) or Dan (dmanak@gobalto.com).

About the author

Leif Erickson is a Director of Business Development at goBalto. He has over 19 years of experience in the pharma and biotech industries, including 5 years of research at 2 La Jolla based biotech companies and helped start the Diversa Corporation.