April 17, 2018 | Norman Goldfarb is Editor of the Journal of Clinical Research Best Practices and Chairman of MAGI. His passion is advancing the practice of clinical research by standardizing best practices in incremental steps, so every day is better than the last. He joins Clinical Informatics News with a monthly column highlighting new ideas for advancing clinical research. This month he speaks with Anita Bowler, Finance Operations Manager at the University of Utah
Huntsman Cancer Institute.

Anita, what do you think it’s about time for the clinical research enterprise to start doing?

It’s about time we recognize the time principal investigators (PIs) spend overseeing clinical studies.

That’s not done already?

Well, sort of. Study budgets typically include line items for informed consent and medical procedures performed by the PI. However, most of the time a PI spends on a study is either considered a “cost of doing business” or implicitly covered in other line items. “Costs of doing business” are presumably covered by the institution’s overhead rate.

What’s wrong with this system?

There are three main problems. The first is that study budgets often ignore or understate the time PIs spend on a study. Second, they do not explicitly recognize the PI’s contributions. Third, they to not correctly map to the way PIs spend time on a study.

Academic institutions like Huntsman Cancer Institute track each physician’s earned hours of work “effort” for government grants, performance assessment, work assignments, and compensation. PIs find it frustrating and demotivating when the effort they make on a clinical study is understated or misunderstood.

Can you give us an example?

Certainly. Study oversight is not just based on the number of study visits and the activities during those study visits. It is also based on the passage of time. Long studies simply consume more oversight time than short studies. If you don’t believe me, look at any CRO contract with a study sponsor.

That’s why we at Huntsman Cancer Institute try to negotiate clinical study budgets that incorporate a quarterly PI oversight fee. The point of this fee is not to increase the study budget, but to structure it correctly for our effort reporting system and to motivate physicians to conduct clinical research and properly oversee their studies. 

Are the sponsors buying it?

Yes, in 60% of our studies now, and steadily increasing.

Are the oversight fees really not increasing your budgets?

In some cases, we are seeing increases, but only in budgets that severely underrecognize the PI’s contributions. In most cases, the PI’s efforts are still not fully recognized, but they like the new approach and it works better with our internal systems.

Well, Anita, that makes sense to me. If the sponsors are going along with it, it must make sense to them too.

Norman M. Goldfarb is Managing Director of First Clinical Research LLC, a provider of clinical research best practices information services. Contact him at 1.650.465.0119 or ngoldfarb@firstclinical.com.