Site relationship management: Sponsors help sites be more productive
Will fewer, high-performance sites get the lion's share of work?
Whether they call it investigator or site relationship management, it seems that big pharma thinks it's just plain old good business. Something they openly admit they hadn't been focused on.
Intentional relationship building
These initiatives, according to Beth Harper, BS, MBA, president, Clinical Performance Partners, Keller, TX, are focused efforts by sponsors to intentionally improve relationships with sites for mutual benefit.
"There is site relationship management [SRM], which I prefer, and investigator relationship management [IRM]," notes Harper. "Focusing on the investigator is one piece, implying more of a sales approach. I think focusing on the site recognizes the broader sense of how clinical trials get done," she added.
Being part of the solution
Sponsors have now acknowledged that sites need help meeting contractual milestones. They know, for instance, that an incredibly high percentage of sites overpromise and underdeliver when it comes to subject enrollment. A great many never enroll a single subject.
Add to the mix increased competition over a declining number of investigators and, according Harper, "pharmaceutical companies realized that they had to make efforts to support and protect their business, which includes clinical sites — and to begin to relate to them as suppliers and customers."
Frustrations — and finger pointing — aside, sponsors are increasingly recognizing that they share a common goal with clinical sites, namely to produce regulatory-compliant and acceptable clinical data in a timely and efficient manner. As a result, many of the big pharma players have spent significant time and resources determining how they might help sites work better.
And big pharma has a big stake in helping sites become better performers. Better data, produced more quickly with fewer redundancies translates into speedier NDA submissions to the FDA.
So this year, many companies, including Wyeth, Sanofi Aventis, and Eli Lilly, are rolling out their IRM and SRM programs. They all have their own unique names, but they all share some common (and complementary) principles:
- Help sites function better. Sponsors have been working to improve and facilitate communication between sponsors and sites and have made available extensive training and "tool kits" to help sites with trial start-up and ongoing monitoring.
- Keep trials moving efficiently. Streamlining, by way of designating a specific sponsor contact, involving investigators in protocol development, and simplifying payment processes, keeps trials on track and running smoothly.
- Increase investigator retention. Happy investigators and clinical sites are more inclined to continue working with the sponsor, and with improved function and efficiencies, may be able to conduct more studies. And if one sponsor can monopolize a particular site, that site might get even better — not having to juggle processes and systems from more than one sponsor.
Sanofi Aventis: Partners
Sanofi Aventis' program began at square one. They surveyed more than 5,000 sites to find out where to focus their efforts. The sites were clear in what they wanted: more effective communication between the site and sponsor, better payment processes, properly trained and professional sponsor representatives, and help during trial start-up.
Wyeth: Site Management Breakthrough
Wyeth's program, called Site Management Breakthrough, is a high-tech throwback to the past in some ways. It calls for more sponsor/clinical site communication, but creates a focused internal contact point to streamline the information-sharing process.
With the technology component, Wyeth hopes to cut months off the amount of time sites spend getting started. But in something much more forward thinking, Wyeth is soliciting investigator input on protocol design to decrease delays encountered with IRBs and protocol amendments.
Eli Lilly: Portfolio Sites
The focus at Eli Lilly hinges upon determining the criteria for identifying high-performance sites. Eli Lilly calls these sites Portfolio Sites and plans to forge intense relationships with them — sites with the right performance may even be offered right of first refusal on future trials.
Eli Lilly recognizes the potential for several economies of scale with their initiative and envisions that it will reduce paperwork associated with contracts and negotiations, reducing start-up time and allowing investigators to focus on other aspects of the clinical trial such as enrollment.
Good business practices
From a strictly business perspective, this paradigm seems to make intuitive sense and there's no shortage of examples of this kind of customer relationship management in other industries. So what took big pharma so long to see the light?
"There are so many fundamental reasons why it took so long," explained Harper. "Much of it has been organizational and a result of the demands placed on CRAs. Often they were simply focused on managing protocols and data, in a very heads down approach, and lost sight of this side of the supply chain."
According to Harper, to successfully implement SRM initiatives, the role of the CRA must change. "In addition to the core functions, CRAs will be called upon to run point on a new set of skills," she notes. Harper calls these skills the "eight ATEs": collaborate, advocate, negotiate, educate, communicate, appreciate, motivate, and evaluate.
Some also thought that technology would save the day and focused on electronic data capture. According Harper, "technology has helped, but hasn't proven to be the panacea some had hoped for."
With the focus on helping sites improve efficiencies and produce better outcomes, everyone wins, right? Not necessarily. While part of SRM clearly cuts to the heart of finding and nurturing the highest-performance sites, it also means weeding out the underperformers. Eli Lilly's aim to consolidate trials — perhaps even portfolios — with a right of first refusal to those sites that perform best is shared by most sponsors breaking into IRM and SRM.
So what does this mean for John Q. Site? It's time to leverage what the sponsors have to offer. Big pharma calls it a site market, in much the way the housing market is a buyer's market. Sites, especially those with demonstrable performance history, should ask sponsors for access to the tools and resources available in their programs.
Then sites need to continue to prove their value by achieving performance milestones. That appears to be the best guarantee of continued (and perhaps increased) collaboration.