By Allison Proffitt 

 

November 22, 2013 | Of the pain points in clinical operations, Infinata believes site surveys are one of the worst: a crucial step to study start up that is often painful and slow. The company invited representatives from the sponsor, CRO, and site communities to Boston last month to discuss needs, ideas, and solutions to the challenge. The company plans to use the results of the discussion to fine tune their forthcoming site survey product that they expect to launch in February. 

 

Dan Diaz, VP of Global Business Development for SPRI Clinical Trials- Global, was part of the conversation. Diaz has been in the CRO industry for 19 years, and before that worked in pharma. During his stint with Marion Merrell Dow (now part of Sanofi), Diaz was involved in grassroots efforts to get patients involved in clinical trials.  

 

The ideas he used then are now back in play, Diaz says. 

 

“Only 1% of patients with cancer in the United States are enrolling in clinical trials,” he says, quoting Tufts University research. “That is very disturbing. It’s not that the industry is saying that it’s cheaper and it’s for cost, only, that we go outside of the United States. It’s really because we’ve had a hard time getting patients with cancers involved in these new treatments.” 

 

It’s time for a change in the industry, Diaz believes. Site selection and patient recruitment must improve. He quotes his mantra: “You can’t do things they way your mother did them.”

 

At SPRI Clinical Trials, Diaz has been using BioPharm Clinical, an Infinata offering, and feasibility tools for about five years, and has been pleased. Tools like Infinata’s help us identify where these patients are, where these interested physicians are, and where the successfully-enrolled studies have been conducted, he said. Diaz says he’s seen evidence time and again that analytics tools out-perform more traditional methods of site survey. 

 

But there is always room for improvement, and Infinata encouraged the roundtable members to give granular feedback. 

 

One of Diaz’s major concerns is that even the best tools for feasibility and site survey aren’t really incorporated into workflows and used. “Many times as a company we have access to these tools but our clinical teams have been hesitant to use them,” Diaz said. “They’re not used to them; it’s not the way their mother did it.” 

 

Diaz said that tools must be designed to be implemented in both top-down and bottom-up ways: “such that the CRAs at the site level can utilize this to validate and to verify the information that they’re getting from their study coordinators at the site. The management teams within these CROs and pharma companies are supporting the utilization and purchasing of these tools even though it may not be a revenue generator.”

 

Diaz also stressed that tools need to be offered as corporate licenses, not charged on a study-by-study basis. “If you’re going to spend $30,000, $50,000, $100,000 on a tool, no project manager can spend that kind of money. Directors don’t usually have the ability to spend that kind of money. It’s got to come down from the top.” But the users are at the study team level: the study managers, the project managers. “You almost have to force people who do startup to use this as part of every project,” Diaz said, so that tools are fully integrated and capabilities are fully exploited. 

 

Other attendees called for a product that “can help with integration issues currently in the marketplace for the site survey process.” And another pointed out: “People do not like having to answer the same questions over and over again. We need a survey tool that pre-populates answers.”

The conversation was an opportunity for Diaz to give feedback, but also for him to get insights and work with others at the table. “I’m always looking at what we can do differently from the site level,” Diaz said.

 

“From a global CRO level, how is Quintiles adjusting and utilizing these tools?... A mid-sized pharma company like Shire… how are they able to bring these new tools to the study level?” 

 

Diaz said the experience was a chance to share experiences with colleagues and learn much. 

 

From Infinata’s perspective, the conversation was equally as rich. 

 

Right now, Infinata clients use BioPharm Clinical to access lists of potential investigators and sites. When it’s time to send out feasibility questionnaires, though, CROs and biopharmas have to transfer their findings to a third party system and start with blank feasibility surveys. Amanda Murphy, head of product development for BioPharm, said the company is hoping to change that. 

 

“We’ve been toying with the idea of a new product, and there are three different industries that are directly impacted by this issue: CROs, biopharmas, and actual sites,” Murphy said. “We had this roundtable to get the three different perspectives into one room and see what everyone’s pay points were, learn more about their workflows, and see how that could be incorporated into a solution.”

 

The roundtable approach is a new one for Infinata, who in the past has beta tested products with clients, but Murphy said that gathering of varied stakeholders was very valuable. 

 

“At Infinata we really learned a lot and gained a lot of insight into this problem that everyone is experiencing,” she said.