Database Studies Are a Favorite for Comparative Effectiveness Research
Comparative effectiveness research (CER) is one of the most exciting types of research for a life science company. The reason for this is CER’s high risk and high reward value proposition. Should a CER study demonstrate that the company’s product is superior to a market competitor, the company can use those data to earn favorable reimbursement and impress physicians who may waver between which product to prescribe. But, should the CER study demonstrate that the competing product is superior — well, let’s not talk about that. CER can be so risky that some companies refuse to fund investigator-initiated trials (IITs) that are comparative studies. As for company-run trials, teams may prefer to dedicate resources to database studies than spend oodles of money conducting trials that may backfire.
Cutting Edge Information’s report, Comparative Effectiveness Research, found that 80% of surveyed global teams’ comparative effectiveness data come from database studies. The percentage is even higher among surveyed country-level teams. Database studies — or retrospective studies — are where teams utilize data from completed trials, electronic health records (EHRs) or other medical records. As such, these studies are substantially less costly than prospective studies because they do not entail patient enrollment, investigator sites and company products — not to mention the staffing and planning required to conduct these studies.
Given the potential risks associated with conducting any type of comparative effectiveness research, it is unsurprising that teams may lean towards conducting less costly database studies. Similarly, many teams conduct CER alongside existing prospective studies. It seems that many companies are hesitant to gamble on prospective, dedicated CER trials.