Goal: Improve Investigator Ties
November 02, 2007
There’s no doubt about it. Site relationship management (SRM) has taken big pharma—and big biotech, for that matter—by storm in the last year. Where there are large, bureaucratic companies developing drugs, there are new SRM initiatives. And conferences on it now abound.
But just what is SRM? Each sponsor and consultant define it differently. Some have a slightly different term: investigator relationship management (IRM). But the principles are the same: it’s a concerted effort to improve business practices and interaction with clinical sites in order to 1) help the sites function better, 2) make investigators happy and keep them coming back (as opposed to migrating to other sponsors), and 3) make sure clinical trials are moving at a fast and efficient clip.
Wyeth is among many big pharma companies launching SRM initiatives this year. Theirs is called “Site Management Breakthrough.”
Wyeth’s Michael Smith says it all began in January, 2007, when the company decided to take a hard look at how it interacted with clinical sites. “It was a deep dive into our roles, our internal processes, our weaknesses,” said Smith, vice president of Wyeth’s Americas Research Organization, the clinical data arm of the company, and the division that’s closely involved in SRM efforts.
From that deep dive, Madison, N.J.-based Wyeth learned that sites were overwhelmed with all the Wyeth employees they had to talk to during the course of a study. (Other sites no doubt feel the same way about practically every company in the industry.) Wyeth also learned that much of the study data was being submitted manually and was redundant, and that confidentiality agreements were slow to go back and forth, delaying start-up times. And payment triggers were not consistent among sites.
As a result, through “Site Management Breakthrough,” Wyeth—which at any given time is enrolling patients for about 50 trials—is now implementing changes that it hopes will help realign interactions with sites. For starters, said Smith, sites will now talk to only one or two people from Wyeth. The site’s primary contact will be with a clinical research associate (CRA), who will take on the role of site manager. In addition, Wyeth has created the new position of regional study manager, who will be the back-up contact for sites.
Call the Concierge
Beth Harper, long-time site management consultant and president of Dallas-based Clinical Performance Partners, explains that this is called the concierge approach. It’s a very popular SRM initiative in big pharma these days.
“The sponsor contact becomes the one-stop shop, triaging all the site’s calls so the site doesn’t have to remember 18 different people’s phone numbers as well as 17 different passwords, which has been overwhelming for sites.”
Back To The Future
Also, Harper—formerly a CRA—said that transforming the role of CRAs from compliance and data manager to that of site manager is common now, and, interestingly, it represents a return to the “old days.”
“In the 1980s, we used to take sites to lunch, have a conversation, get to know them, and help them, even before the study started,” Harper recalls. “Then e-technologies came in and the number of encounters was reduced. CRAs could just check the data online, and visit the site every three months instead of every month. The sites were then out of sight, out of mind. Now we’re seeing sponsors return to the old way, with more contact with just a few key people, which is what the sites need and want.”
While Wyeth is trying to step up the human contact, it’s also stepping up the technology. The company plans to establish a Web portal through which sites can submit data in a “more streamlined fashion.” (The company declined to say what sort of information will be available in the portal, or what sorts of regulated or non-regulated systems will populate it with data.) Previously, said Mark Ridge, Wyeth’s director of global enrollment planning and performance, it was “all paper” with lots of redundancy.
And, said Ridge, using the portal should “cut two months off start-up times for sites” that are new to Wyeth trials, and even more time for those who are not. Signing confidentiality agreements will be reduced to a mere click, instead of taking four to eight weeks sending paper back and forth, which is typical now, said Ridge.
In addition to getting studies started faster, this new form of study-data entry will allow Wyeth to hold overly enthusiastic investigators to their enrollment promises. “That’s probably the No. 1 problem we have,” said Ridge. “Some will say, ‘I’m sure I can get you 10 patients for this study,’ but the average is actually 4.5, and 39 percent enroll zero to one patient. That’s an incredible cost to us. We’re looking for predictable enrollment.”
And investigators will be able to check the new Web portal to see how they are doing, as it will include site performance data. The portal will roll out in phases starting in early 2008.
Another common IRM initiative Wyeth is undertaking is asking investigators to get involved with protocol design. In a recent oncology study, investigator feedback from Europe, Asia Pacific and the Americas shaped the redesign of the protocol prior to the study start, according to Ridge. “This enabled us to revise the protocol and eliminate the delays of a protocol amendment,” he said.
Payment problems, too, have been a big complaint among investigators industry-wide, often listed as a reason compelling them to completely give up working on clinical trials. So naturally, changes to payment systems are part of many current SRM efforts. And Wyeth is in that number. Wyeth is working on automating payments, making them simpler, more standardized, more reliable. “Across our studies,” he says, “it may not be consistent what the triggers are, so we will harmonize that.”
Wyeth’s “Site Management Breakthrough,” comes on the heels of its “Enrollment Breakthrough,” which went on for a year and a half. The current initiative, according to Ridge, is expected to run indefinitely. And while it’s a very important effort for the company, Wyeth has not hired any new employees for it. Rather, said Ridge, it will involve a reshuffling and realignment of the positions the company already has.
“Our goal is to start getting better at building relationships with sites,” said Ridge. “It will be based on us working hard to improve what we can improve, and holding sites accountable, so at the end of the day, it will be a good relationship for both parties.”
Less is More
That is, among fewer sites. “Clearly we want to work with high-performing sites,” said Ridge. “We want to work with less sites if we can.” Ridge elaborated by saying that Wyeth is looking to decrease the number of sites per protocol by hopefully driving up the number of patients per site.
Also, Wyeth says it will be investigating beefing up site training.
When all Wyeth’s new efforts are implemented and chugging along, the perfect investigator feedback, said Ridge, would read something like this: “That we got them up and going quickly, that we set them up for success, that they got all the information and training that they needed up front, that we have the correct infrastructure for communicating with them, that we paid them rapidly for quality data, and that we are the company of choice for them to work with.”
—by Suz Redfearnd9A2t49mkex