More than $4bn is spent annually to treat uterine fibroids in the US, though there is little scientific evidence about which treatment options are better than others, according to PCORI.
Michelle Leavy, senior research associate at Quintiles, told Outsourcing-Pharma.com that it’s rare for a CRO to win such a grant as most of them are awarded to academic researchers. But Quintiles won the award because of its previous work in uterine fibroid treatments, including a stakeholder panel held in 2010, and its access to two databases of de-identified patient data, Leavy said.
To conduct the research, Quintiles will analyze more than 33,000 electronic medical records linked to insurance data, as well as data on more than 20,000 women in a network from various health systems. The company will analyze patient demographics, diagnoses and symptoms, treatments, and laboratory results. The research will focus on three objectives:
- Estimating how long relief from symptoms last for treatments other than a hysterectomy;
- Estimating how long treatment effects will last for all treatments including hysterectomy, as measured by the return of symptoms after the initial treatment; and
- An examination of how patient and physician stakeholders involved in the research process affects the study results and interpretation.
Leavy said the third objective is different from other comparative research the company conducted in the past because it will compare the original investigators’ analysis plan with how it was altered by stakeholders’ views.
The main outcome of the study will be length of treatment effect after various treatments for fibroids, and Leavy said the payment of the award will come as certain milestones are met.
More Opportunities for Comparative Effectiveness?
Quintiles is interested in performing more research for PCORI, Leavy said. The institute has approved 51 awards totalling $81.6M over three years for comparative effectiveness projects.
But Leavy also said that prospects for such comparative effectiveness research contracts from pharma or biotech companies seem slim because they are not required by regulators to conduct it.
Innovation Award
In addition to the PCORI award, Quintiles also recently won the 2013 Informatica Innovation Award for “Enterprise Data Integration.” The company won the award for its Infosario solution, which can integrate both clinical research and healthcare data across numerous institutions in the biopharmaceutical industry.