Driving ROI Analysis

Richard Malcolm of Acurian explains how to get the best ROI in patient recruitment.

“Patient recruitment is going to stop being a black box”
-Richard Malcolm

Why is ROI such a hot topic in patient recruitment today?

Richard Malcolm. There are more and more requests from senior management at the larger pharmaceutical companies to show the value of the money that's being spent on patient recruitment and ultimately, to show the return on investment. Cost pressures have been impacting the pharmaceutical industry for several years now, and there has been continued pressure to speed up the very expensive development process to try and get drugs to market as soon as possible, to get revenues as quickly as possible, and to get as much patent-protected revenue as possible. 

Do the individuals who are randomized into a study come from the sponsor or the site's own sources, or do they come from the recruitment program?

RM. What you really want to able to do regardless of whether you're using newspaper advertising, television commercials or direct mail, is to be able to demonstrate on a regular basis – and regular basis being either weekly or biweekly – that the external recruitment program is contributing a measurable number of enrolled patients and that that contribution is additive or on top of the site's normal recruitment contribution. We've seen when we've done these programs and tracked them very closely that the external recruitment program does, in fact, enhance the number of patients that wind up being enrolled per week or enrolled per month so that you get an additive effect rather than a replacement effect.

What are some of the metrics sponsors should consider when measuring ROI?

RM. The recruitment organization should be able to provide you with a set of expectations that are driven off of a predictive model. If they've done a lot of this work, they should have a very high degree of confidence of what their recruitment curve is going to look like, how long it's going to take before randomized patients start showing up in the study from the external supplier, what the flow will be, and what the process needs to look like to hit not only the enrollment objective in terms of number of individuals, but the target date. And then on a regular basis, either a weekly or biweekly, you should look at the number of enrolled patients, and look for trends in the number of enrolled patients, including number enrolled per week and total number enrolled in the study, versus the planned enrollment or versus the predictive model that has been provided to you by the recruitment program.

What trends do you see occurring over the next decade that will impact not only ROI but patient recruitment in general?

RM. Patient recruitment is going to stop being a black box and is going to start being much more of an analytical metrics driven process, and the reason is that without those kinds of metrics it's impossible to make any kind of meaningful assessment of whether or not you got a good return on investment, of whether or not you spent the money well. It's increasingly difficult for the study team or the recruitment specialist at the pharmaceutical company to be able to go back to their management and say, "Here is what I spent, here's what I've got and here's the net financial impact for our company." 

There will be much more attention given to doing some really solid financial analysis to show the benefits of spending money on patient recruitment. People are interested in knowing and understanding and getting a stronger sense of how good of a spend this is. Also, there will be a greater likelihood that recruitment programs will need to achieve enrollment objectives within a desired timeframe, so not only will you be driven by generating the patients that a pharmaceutical company hopes that the external recruitment provider can bring in, but also within a timeframe, and this will drive the ROI analysis.

Richard Malcolm is Chief Executive Officer of Acurian. He brings over 22 years of experience in healthcare management to the company. Malcolm was previously VP, Business Development, for ICON Clinical Research, served as worldwide head for what is now Quest's central laboratory, and held senior management and consulting roles at GlaxoSmithKline and start-up pharmaceuticals.