When French pharmaceutical company Sanofi-Aventis (SA) recently gathered representatives from several investigator sites to ask them for feedback, the drug maker got a shock. An SA executive began to talk about an electronic collaboration portal, one where sites could interact with the sponsor, and he got cut off by what amounted to boos and hisses.
“Turned out, they don't want any more passwords. They don't want any portals,” said Richard Robinson, the company's assistant director of internal medicine, metabolism and diabetes group in the U.S. “They said instead that they wanted paper, binders—something tangible they could put on their bookshelf and say, 'That's my Sanofi-Aventis study.”
The firm was taken aback. “We were shocked,” says Gretchen Goller, head of patient recruitment for SA as well as the company's compliance strategist for operations. So SA decided to probe further, quickly discovering that many sites get overwhelmed with the myriad systems and portals used by its various sponsors, even if the technology is tip top. Instead, a lot of sites would rather have something they can hold in their hands for each trial. They'd rather have a CD-ROM to pluck off the shelf if they need more info about a study's protocol or standard operating procedures (SOPs).
So SA—as part of its investigator relationship management (IRM) program—decided to abandon its plan to become ever more electronic like everyone else in the industry. Instead, it tailored communications to suit each site. Through its monitors, the company now asks each site how it wants to communicate—and uses that channel. “Some want email, some don't,” says Robinson. “Some want portals, some don't. We find out.”
That was part of SA's so-called Partners program, which stands for Productivity And Results Through Knowledge Exchange and Relationships. (The words/letters don't exactly create the label, but no matter.) When last we checked in with SA about its investigator relationship efforts more than two years ago, the program was called Cupid: Commitment by the U.S. CRU [clinical research unit] to Partner with Investigators Daily. (The article we wrote then is here).
That all changed in early 2008, when corporate leaders decided Cupid didn't sound serious enough, Goller says. Thus far, the program applies only to SA's 4,000 or so sites in the U.S. But talk of international expansion is afoot.
As part of the program, SA surveys its U.S. sites about every two years, asking a series of questions designed to learn what the sites would like to change about their relationship with the sponsor. The survey has been evolving. For instance, for the most recent one, SA targeted only sites that currently had an ongoing SA study. The company got a 22 percent return rate from those 3,000 sites. Also, SA scaled back the number of questions it asks from 49 to 20, hoping to avoid survey fatigue and thus nonresponse.
Face to Face
And more recently SA has been gathering representatives from about 20 of its sites for a day-long feedback session. When told about the meeting and asked to attend, most sites are stunned. They've never been asked for that type of feedback from a sponsor before. Some feel anxious about sharing at first, but quickly open up. Typically what comes out of the meetings and the surveys are a mix of complaints about matters that SA can and can't change.
In the can't category, for instance: the amount of time it takes a protocol to come out of SA's headquarters in France, says Goller.
In the can category:
• Payment: Goller says sites weren't complaining about the amount of payment, but rather that they weren't paid with sufficient frequency or punctuality. To remedy that, in 2009 SA committed to paying sites every two months instead of every quarter, and making sure that all payments are on time.
• Compound training: “When they have someone come to their site from our company, sites didn't feel like the person knew as much about the compound as they would have liked them to,” says Goller. SA's response was to move toward a model where monitors are no longer assigned to trials based on geographic location, but rather therapeutic area.
The shift—currently underway—is for each monitor to have expertise in two areas, one primary and one secondary. When more training is needed, SA now provides it. “It's rolling training now instead of the one session we were offering monitors before. If you don't feel completely comfortable in your therapeutic area, tell us and we can have you in in-house training or live modules right away; it's always available now,” Goller says.
She adds that it was a good time to implement the new monitor plan, as SA has recently had its share of restructuring and much of the contract staff was let go.
• Start-up chaos: Previously, when SA would initiate a study with a site, there were no set employees who handled specific parts of the start-up process; it was piecemeal. That left sites frustrated, and unclear about who to call for help. So SA amassed a group of employees that focuses specifically on study start-up. Employees are assigned to specific parts of the process—negotiating budgets, collecting contracts—so that everything moves efficiently. Now sites know exactly who to talk to about what during what tends to be a frenzied time. Everyone's happier, says Goller. And when the study starts, a study team takes over and the site's main contact is the clinical research assistant.
• The electronic case report form (eCRF) system: A year and a half ago, the powers that be at SA decided it was going with a system from Oracle, and that fell into the things-that-could-not-be-changed category. But sites were frustrated about various parts of the system. Within the Partners program SA created a way for sites to be able to get their feedback to the tech team. This was far better than sites just complaining to monitors or random people who picked up the phone at the third-party help line. “There were lots of obstacles and barriers to getting the message to the people who could do something about it,” says Robinson. But no more.
Sites subsequently let SA know directly that the system was too slow. SA added another server to speed things up, says Robinson. Sites reported that training for the system was far too cumbersome and time-consuming, involving information not actually needed by the sites. SA then streamlined the required training.
Two years ago, SA's Cupid program had begun an initiative called “Toolbox” that the Partners program has continued. The toolbox is an old-fashioned briefcase filled with visually pleasing items designed to help each site with study start up. Contents can include: a laminated flowchart explaining how to submit a serious adverse event; an informed consent flip chart; small cards on which inclusion and exclusion criteria are listed—each with the study's logo on it. But now, instead of giving all items to each site, the sites are asked what they need, what would help them. Some bite, some don't. Says Goller, “Some sites are so organized, they say, 'I don't need your tools.' Others say, 'God, I want everything.'” It's a tailored approach.
Another key part of the program has been the study scorecard. Says Goller, sites told SA they wanted to know how they were doing on each study compared to their peers, so the company began generating a scorecard at the end of each study letting them know how they scored on various metrics. Then sites began asking to get their scores mid-study, so they could see where they needed to improve. The sponsor obliged.
Now the company also takes special care to send these comparative metrics to sites that are not enrolling at all, so that they might be awakened. Often, it works. “Right after they get their score, many start getting patients into the trial. It's a motivator,” says Goller.
Goller says SA prefers the idea of improving relationships in these ways with each of its sites—not selecting just certain sites to focus on, as many sponsors and CROs are now doing through preferred sites programs. “That just seems exclusionary,” says Goller. “We want to include everyone and get them what they need.”
—by Suz Redfearnd9A2t49mkex