Running clinical trials is increasingly complex and costly, but the most vexing part may be finding suitable patients when they are needed. That can be especially true in the US, for instance, where participation rates are often low and many people are already taking at least one medication. So perhaps it may not be surprising to learn that, when it comes to preparing a clinical trial, drugmakers value speeding the time spent to recruit patients over lowering costs.
A new survey finds that nearly 90 percent would prefer reaching patient recruitment goals at least 10 percent faster over cutting Phase II or Phase III trial costs by 20 percent. In fact, only 15 percent of the 72 drugmakers queried chose reduced expenses over faster patient recruitment, according to Industry Standard Research, a market research firm that conducted the survey.
The results belie a level of dissatisfaction, which may explain why half of the drugmakers reported that they prefer to do patient recruitment work themselves, even though clinical outsourcing is, overall, commonplace. But when recruitment is outsourced, the survey found that of the 12 large and mid-size multi-service CROs evaluated for patient recruitment activities, only three met or exceeded expectations greater than half of the time.
The next highest response at 25 percent was for “a specialized patient recruitment company," followed by each of the 12 CROs. The drugmakers were asked to grade CROs based on services provided during the past 18 months. Which CROs were included? They were Covance, ICON, INC Research, inVentiv, MDS, Medpace, OptumInsight, Parexel, PPD, PRA, Premier Research, Quintiles, RPS and Theorem.
The survey also found that advocacy groups are believed to be best at delivering a desirable recruitment return on investment, while investigator-related activities, such as referrals, posters in exam rooms and direct letters from doctors, have provided moderate-to-high ROI in recruitment. The tactics that were deemed less successful included traditional print, digital, and broadcast advertising.
To be more specific, 75 percent of the drugmakers surveyed reported that advocacy groups - which were also called affinity groups - have average or above average value in recruiting patients. Doctor referrals were a very close second, with 74 percent of the drugmakers viewing this activity in the same way. Meanwhile, 60 percent held this view of placing posters in exam rooms.
This also suggests a growing willingness to dabble in social media, which is gradually being pursued in different ways. Quintiles, for instance, runs a web site called ClinicalResearch.com that provides info about trials and will be increasingly used to recruit patients. Pfizer, however, recently experienced difficulty relying on social media for recruitment for a trial that will allow patients to participate from home by using computers and smartphones instead of going to a clinic or doctor’s office (back story).
Another key finding: the level of engagement of the clinical trial site staff and characteristics of the study protocol were the two most important factors that lead to successful recruitment efforts. Twenty-five percent of drugmakers cited investigator interest in the study leads to success, followed 19 percent that pointed to either inclusion and exclusion criteria or the protocol design.