Info & Opinion
July 21, 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
In the early 1990s, site management organizations (SMOs) began to form. The idea was simple. Sponsors would be happier if they could go to a single company that served as the management headquarters of many sites, instead of having to approach many disparate, individually run sites separately and forge contracts with each. SMOs like Radiant Research started to scout around for sites to buy.
Investigators like Jeffrey Rosen, a family physician, watched the process and wondered. At the time, Rosen was one of two partners running Clinical Research of South Florida, a four-physician, four-coordinator site in Coral Gables.
“After going to a lot of the meetings, I started to see the same faces, and we began to talk,” Rosen recalls. “We all thought that SMOs weren't the way to go—that we wanted to maintain ownership of our sites. And we started to ask each other: 'What do you do? What are your best practices?' ”
Thus was born the Alliance for Multispecialty Research (AMR), a 15-year-old network of individually owned, geographically diverse sites from Maine to California. The members share not only best practices, but leads on studies and nuances of contracts.
The AMR grew fast. After starting with seven members, it now has 18 partners with six satellite offices. In the last five years, alliance members have enrolled more than 100,000 study subjects across multi-therapeutic indications with retention rates in the high 90th percentiles.
Slow SMO Growth
Andrew Lewin, owner of the Los Angeles-based site National Research Institute, adds that back when the alliance first got off the ground, the members decided to watch the industry closely to see if SMOs became favored. If they did, the alliance would be poised to quickly become an SMO itself, he says. If not, the group would persevere as a collection of closely knit sites that share almost everything except ownership.
SMOs did not, in fact, take off. “The industry wanted more control over the sites they use, and became very dissatisfied with SMOs because they saw that there were some very poor sites that are included in SMOs," says Lewin.
There are no poor or weak sites in the alliance. Explains Rosen, each site is hand picked, invited in by already existing members who are impressed by what they see. And sites only get the nod if certain criteria are met. The criteria are periodically raised; not just any site can qualify. Each must pull in at least $1.5 million a year in income from research; have been in the field for at least five years; have at least six coordinators; work hard to provide fast study start-up; have a clean record; and pass an on-site review.
“We didn't want this to just be a numbers game; we wanted to be a center of excellence for research,” says Rosen. As it turns out, each of the sites in the alliance now has in excess of 20 years experience.
The major upside for alliance members? Access to trials. Patricia Larrabee, founder and CEO of Rochester Clinical Research, says that after her site joined the alliance in 1999, it went from working on 20 studies a year to working on about 50. “It took us to the next level,” says Larrabee.
There's also the added ability to be able to talk to each other about contracts. Or compensation. Rosen notes that lately many sponsors have been trying to get sites to sign a contract holding a site responsible if something goes wrong with a trial—even if it's outside the site's control. The alliance members discuss the issues in detail, keep each other educated, and present a united front.
“A lot of sites don't know any better,” says Rosen. “You're site A, you want this study, and you might think, well, what are the chances of getting sued?”
Peer To Peer
For some sites, the biggest upside of being in the alliance is the connection with other sites. Lewin, who's a thought leader, doesn't actually look to the alliance to bring him more work; his dance card is usually full. Instead, he wants to connect with others in the same boat.
Says Lewin, “The major benefit for me is that I can talk to people who face the same kinds of problems I have. With the FDA, or sponsors. We can talk about non-collection, or monitors, and they know immediately what I'm talking about. I can email the group and say, 'Where do you get a minus-70-degree freezer?' and usually four to six people respond right away.”
The cost of being in the alliance is a flat fee: from $1,200 to $1,400 per month. That covers the overhead on the alliance's headquarters in Nashville, as well its two full-time employees. The executive director is Brenda Atchison, formerly senior global director of project feasibility and investigative site services for Covance. For the alliance, she wears many hats, but focuses mostly on business development. She came aboard in 2000.
“Brenda is so well-connected,” says Lewin. “She knows everybody. And you have a problem with anybody? She can solve it.” She's excellent at conflict resolution, and finding studies fast. For example, Lewin, who mostly focuses on diabetes, says sometimes he'll have a lot of hypertension patients and no hypertension trials. “I can call her and say, 'Where are the hypertension trials?' and she can give me a dozen references.” Adds Larrabee: “She networks for all of us.”
And she'll help guide sites into new lines of business. “She convinced me to get into vaccine work, which a lot of people are doing,” says Lewin. “The alliance helped me with any problems I may have had getting started in an area that's so competitive.”
Every once in a while a sponsor will use all of the sites in the alliance for a study. A master contract is used, and each alliance member agrees to the same budget. When this happens, Atchison sets up a core team through which all the sponsors' or CROs' questions and concerns can be funneled so that it doesn't have to talk to each site individually. “It's very fast—almost like dealing with an SMO,” says Atchison.
Unlike an SMO, which might charge a sponsor extra for access to its sites, sponsors don't have to pay alliance members extra to access sites. Sponsors or CROs just pay the site a regular per-patient fee. “We can turn contracts around in a couple of days, and we don't charge for feasibility,” says Atchison.
The alliance has worked with CROs in helping them land a trial from a sponsor, says Lewin. The alliance will send an investigator or two to the pitch meeting with the CRO, where an investigator can talk about all the patients he or she can recruit. If the CRO gets the contract, so do the sites. They work as a team.
All the sites in the alliance agree to not compete with each other directly. The rule is that they can't have offices within 50 miles of each other. A few sites have dropped out of the network over the years. Most left because they were bought. Some dropped out after personality conflicts arose, says Rosen. None have ever been asked to leave. “It's really worked out to be a good group of friends,” he says.
What's next for the alliance? It isn't seeking new members. “We have reached our max and haven't been looking for new sites,” says Rosen. “It's hard to run an organization with 25 points of view. Eighteen is enough for now.”
—by Suz Redfearn