In the January issue of The CenterWatch Monthly, I wrote about using insurance claims and electronic health records (EHR) to understand patient availability for clinical trials. Combined, these sources can tell you if enough patients meet the criteria, enabling redesign and better planning.
Once you know the patients are out there, how do you find them? Traditionally, sponsors send feasibility questionnaires to prospective investigators. Estimated patient counts are infamous for being too high. It is no wonder that Tufts data shows that only 38% of sites meet their enrollment targets. Consequently 94% of studies must increase their enrollment timeline to meet targets.
Hiring investigators who have enrolled well previously may ensure quality, but not necessarily the quantity. I recommend these two objective methods.
First, identify the geographic areas with the highest concentrations of patients who satisfy your trial protocol. Good prevalence projections use the inclusion/exclusion criteria. For example, suppose a trial needed diabetics without hypertension. The national prevalence of those who present for treatment is 2.2% of adults. This is lower than you might expect, because three-fourths of diabetics have hypertension, and we just excluded them. The city with the greatest recruitment opportunity for a trial, and perhaps a vacation, is Honolulu, with 3.8%. (Source: Optum insurance claims.)
Second, create a national investigator list, ranked by the number of patients who qualify. Insurance claims have this information as well. For the diabetics without hypertension, there are about 17,000 treating investigators in the U.S., out of about 130,000 active ones with experience. The top one is a group practice, with 254 qualifying patients in the past year.
Everyone says fish where the fish are, but do you have a fish finder? If you lack tools to find investigators with patients, it might be time to reconsider.
Written by Guest Writer Bill Gwinn. Gwinn is Vice President of Clinical Informatics Solutions at Optum, a subsidiary of UnitedHealth Group, a diversified managed health care company. Bill supports the clinical trials of new drugs with medical statistics. His expertise lies in quantitative analysis for site selection and finding patients. Prior positions include the Medstat Group at Thomson Reuters, IMS Health, Schering-Plough, and Procter & Gamble. Bill holds an MBA from the University of Chicago and a BA from Vanderbilt University. www.optum.com.
This article was reprinted from Volume 23, Issue 04, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact firstname.lastname@example.org. Subscribe >>