Info & Opinion
March 25, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
Do large pharmaceutical companies need to go back to the drawing board on matters like basic respect in their relationships with clinical sites?
Kim Oliver of Sanofi Aventis thinks of it this way: “The pharmaceutical industry is under a lot of pressure to do things faster, and with less money and fewer resources. And it’s the same as in any personal relationship between two human beings. When one of them is under severe stress, we get irritable, short, impatient. And instead of thinking to then invest in the relationship, you take shortcuts.”
Oliver continues. “In our industry, when we’ve gotten really stressed with time lines, instead of saying to sites, ‘How can we support you?’ we’ve said, ‘Hey, you told me you were going to enroll more patients!’”
Her job for the past year has been about reversing that, at least within Sanofi Aventis. Last February, she hatched and began leading an investigator relationship management (IRM) initiative called “CUPID: Commitment by the U.S. CRU (clinical research unit) to Partner with Investigators Daily.”
It sounds touchy-feely, and it is. That’s the whole point. To re-introduce elements of decency and sensitivity into an industry-wide relationship that (let’s face it) has been tense.
“We have a more humanistic approach to investigator relationship management,” said Oliver, whose official title is regional operations zone lead. “It’s a partnership, and it needs to involve trust and respect. We want to be the sponsor of choice, and it’s just natural to want to work with someone you like.”
It’s a ‘Site’s Market’
Right now, as in the real estate industry, it’s a buyer’s market. In the clinical research world, it’s a “site’s market.” With fewer and fewer of sites out there, those that remain are in a position to pick and choose which sponsors they work with, tossing out the rest, said Oliver.
How, then, to get the sites to like Sanofi Aventis best? It was all in listening closely to the 5,200 responses the company got when it sent out a site survey last year. What sites told Sanofi Aventis was that the top four areas of unhappiness for them involved: fractured communication; less-than-ideal payment processes; sponsor employees who were not properly trained and/or did not act professionally; and insufficient help during the study start-up process (not necessarily in that order).
“That hurts a little but, but hey, it’s totally within our control to improve,” said Oliver of her reaction at the time. Thus was born CUPID, with Oliver amassing four internal teams to look at how to remedy each of the four top site annoyances. These teams are expected to work with others to enroll others in their working groups eventually, for a complete organic buy-in.
The fastest-moving team was the one focused on site start-up. This fall, CUPID’s first pilot project is being launched: the tool box. Each site will get an old-fashioned briefcase filled with tools that should help them at the initiation of a study and during the project. What will be in the briefcase? Among other items, a laminated flowchart explaining how to submit a serious adverse event, and small, easy-to-carry-around cards on which inclusion and exclusion criteria are listed.
No More Guessing
This, says Oliver, is an improvement on what the sites were given before: a copy of the protocol, which was usually 75 to 100 pages long, through which site personnel would have to flip looking for answers. They’d either do that, or just guess what to do, based on what other sponsors had had them do in similar situations, Oliver said. It was not good.
This fall, Sanofi Aventis is sending out brochures outlining the upcoming changes to all site monitors; who will discuss the outreach effort with sites, explaining that the sites’ complaints have been heard.
What Not to Wear
While the tool box is being piloted and the brochures are going out, Sanofi Adventis clinical research employees are being trained in “soft skills” in order to do better in the communications and professionalism realms. That includes tips on writing better e-mails (not using all caps, avoiding several exclamation points as well as bold and underlined words); tips on dressing more professionally (no tank tops); conference call etiquette (no cell phones, no radios on in the background).
The upshot is that every interaction a site has with a Sanofi Aventis employee—whether in person, on the phone, or via e-mail—will not erode the site’s relationship with the sponsor, but improve it, said Oliver.
Partner—Not Mere Supplier
Oliver said she knew her messages were getting through when she overheard two clinical project assistants chatting about drafting a delicate letter to tell sites that they were not chosen to participate in a particular trial. One stopped mid-sentence and said, “But wait, how can do we do this in a way that will preserve the relationship with them?” That’s when Oliver said she realized employees were starting to truly embody CUPID.
Oliver admits that much of this is basic human communication and professionalism. “It’s about valuing the relationship between the two parties,” she said. “And I know that is the most basic thing in the world, but you’d be surprised how much we don’t do that. We don’t slow down long enough.”
Forgetting P’s & Q’s
In the industry, Sanofi Aventis’s efforts have been seen as pioneering, said Beth Harper, long-time site management consultant and president of Dallas-based Clinical Performance Partners. “This really is about the basics of how we treat the customer with good intentions for the betterment of what we’re trying to do. Sometimes we get so consumed or busy, we forget to say ‘please’ and ‘thank you.’ That’s what this is about. And Sanofi Aventis gets that.”
And money? Oliver says it turns out that sites weren’t upset about the amount they were getting, but rather about the way the money is processed—or isn’t processed. “What they really want is an efficient payment system,” she said. “They want it sooner, and more frequently. It’s all about cash flow.”
Oliver says the CUPID team that’s focusing on money is just about finishing looking at what’s wrong with the payment system. Next, it will set to work changing it. That may include automation (it’s all done by paper now) and raising the frequency of payments to sites. Oliver says that once the company is done with the payment-system overhaul, it will give each site a flow chart that explains how the financial process works. The company will also give contact information for who to call if a site doesn’t receive payment. Sites are not provided such information now.
How Long? Forever.
Oliver plans to keep the surveys coming, asking sites for quarterly updates on how Sanofi Aventis is doing in its quest to become the sponsor of choice, while also providing updates to sites on how the company’s investigator relationship management (IRM) efforts are coming along. Until when? It may never stop, said Oliver, who sees this as an ongoing process.
CUPID is touchy-feely, yes, but Oliver will be the first one to tell you it should deliver practical, tangible benefits. In the end, it’s also about better trials. “We don’t want to be just someone everyone loves, we want to improve outcomes,” she said.
—by Suz Redfearn