Ahead of the ePRO Curve?

Applied Clinical Trials

On Monday, Quintiles and invivodata announced their enhanced relationship, that is Quintiles has chosen invivodata as its preferred ePRO provider. Coming on the heels of last month’s FDA’s final guidance on Patient Reported Outcomes (PRO), it appears that both Quintiles and invivodata may be ahead of the curve in their combined ability to offer PRO and ePRO services to clients.

Paula Brown Stafford, executive vice president, Integrated Clinical Services for Quintiles told Applied Clinical Trials that it has completed nearly 700 trials using EDC to date. And of the active trials it manages, 75% of the data is collected electronically. “It is a standard now and paper is the exception to the rule,” said Stafford.

Outside of ePRO, which encompasses invivodata’s product lines that support the electronic delivery of the Patient Reported Outcomes instrument, invivodata also brings its substantive PRO Consulting services to the table in this partnership. Doug Engfer, co-founder and CEO of invivodata elaborated and said, “The consulting side will work with Quintiles health economics and outcomes research to fit the PRO data collection within the go to market models of the sponsor and make sure that endpoints meet the market strategy of the drug.”

Stafford noted that she has seen only a slight increase in sponsors requesting PRO or ePRO in recent years. However, she said, “We think they should be collecting more data and designing more trials with PRO data. And we do see from the December release of the Final Guidance that FDA is urging more use of PRO and data from the patient perspective.” And Stafford’s plans are to be there with the tools when her clients request them, because she does believe the use of PRO and ePRO will increase.

Choosing a preferred provider in ePRO was an extension to its choice of Phase Forward for the same status as EDC provider in 2006. “While we will use whichever provider the sponsor wants to, but if we have the choice we will use the preferred provider,” explained Stafford. “We see efficiencies in using the product numerous times, in terms of working with the product as well as a better relationship with the provider.”

In choosing to bestow preferred provider status, Quintiles has to have some experience working with the company. In invivodata’s case, approximately a six-year history, with over 20 joint studies, involving over 10,000 patients. Stafford said, “With invivodata, we saw the best fit with their technology and with their representatives.”

In addition to Phase Forward and invivodata, other preferred providers for Quintiles include Cenduit, a joint venture with ThermoFisher for IVR and IR tools, where Quintiles actually owns 50% of the company; and it is in the process of choosing an imaging provider, which will be announced sometime in 2010.

Meanwhile, with FDA’s support on the side of the patient perspective in the Final Guidance and Quintiles' choice of invivodata as its ePRO Partner, invivodata is feeling both humbled and vindicated. “This partnership with Quintiles as the leading pharmaceutical services company reinforces that we are the leader in ePRO,” said Engfer. “And it validates our approach to collecting PRO data.”

The company founders—Saul Shiffman, PhD, Jean Paty, PhD and Doug Engfer—joined to form invivodata in 1999, based on academic and professional experiences of Shiffman and Paty in psychology, clinical trials, and electronic patient diaries dating back to 1987. That experience, coupled with Engfer’s software development and entrepreneurial experience, have brought the concepts of PRO collection to electronic patient diaries, and the industry at large, forward. The convergence of these talents and FDA’s acknowledgement of the patient in clinical trials, 20 years in the making, is a success story for the Pittsburgh-based company. As Engfer said, “We are excited about 2010.”

Related Blog, PRO: Power to the People