As a clinical research assistant (CRA) in the 1990s, Darren McDaniel didn’t like what he saw when it came to institutional review boards (IRBs). From what he witnessed, sponsors had two choices: go with a slow, bureaucratic university- or hospital-based IRB, which typically convened once a month and tore protocols to shreds. Or go with a commercial IRB that worked quickly but ultimately just green-lighted studies without closely scrutinizing the protocol.

“I thought, why can’t I set up a central IRB that is zealous about protection of the human subject, is not a rubber stamp and challenges drug companies and doctors, but at the same time provides amazing customer service?” McDaniel remembers.

No Rubber Stamp

So, in 2001, he did. McDaniel launched Coast IRB. Now, it’s one of the bigger players in the commercial IRB space. And it’s the only IRB ever to make Inc. magazine’s list of America’s 5,000 fastest-growing companies, where it showed up in 2007 and 2008. This is thanks to growing an astonishing 980 percent over the last three years, says McDaniel.

How? McDaniel says it’s a mix of integrity and customer service. Sensitive to the criticism that commercial IRBs can be compromised because they are paid by drug makers to do their job, he makes sure his eight board members (and two back ups) have no affiliation with his company. They are not employees, but rather independent contractors paid in fee-for-service fashion whether they approve a study or not, he says. Many other commercial IRBs pay a flat stipend and the board members are not entirely autonomous, he added. Some might even have a financial stake in the IRB.

In addition, in order to make sure the industry knows Coast is on the up and up, the IRB just executes one contract with sponsors at a time. “Mandating that they use us for a certain number of projects could create the perception of a biased relationship,” says McDaniel.

Saying No

And Coast stands up when it comes across a faulty protocol, he says. McDaniel still seems upset when he tells the story of a study that came across his board members’ desks in recent years. The board thought the study subjects—women—needed to be advised to use birth control for the entire month during which they consumed the study drug. The drug maker felt five days was sufficient. Coast’s board (which includes a obstetrician-gynecologist) insisted on a month. The sponsor didn’t budge. And Coast did not approve the study. (Unfortunately for the patients, the sponsor was able to approach another IRB and have the trial approved without modification, McDaniel said.)

Though the commercial review board arena has seen much growth in the 1990s and 2000s, there are still many more university- and hospital-based review boards—about 5,000. (In the commercial arena, there are 40 to 50.) Most government-funded research goes through the university or hospital review boards, while most studies funded by drug companies go through commercial IRBs, McDaniel said.

500 Trials Per Year

Other larger commercial IRBs include Western Institutional Review Board of Olympia, Wa., (dating to 1968) and Quorum Review of Seattle.

Last year, Coast reviewed about 500 studies. Over its lifetime, the company has vetted about 2,500 trials, working with about 2,000 customers in each phase of research and an array of therapeutic areas. Its board meets twice a week and thus can turn a study around in about a week, compared to the three or four months a university- or hospital-based IRB may take, McDaniel said.

16,000 Possibilities

McDaniel is candid about cost. His IRB’s services run a sponsor about $1,500 per doc per study, and that includes the review of everything: initial protocols, protocol amendments, advertisements, consent forms, and continuing review.

“There are 16,000 drink possibilities at Starbucks, and that’s what people currently want in the business world: customized, flexible solutions,” McDaniel says. “So, that’s what we do.”

“Some tell us they want paper documents sent to them using FedEx, so we do that,” he continues. “Some want us to scan and e-mail them, and also FedEx and upload them to a web portal, so we do that. We customize based on unique needs.”

The Highway

This, says McDaniel, is a far cry from the “my way or the highway” attitude that he saw within hospital- and university-based IRBs when he was a CRA, and still encounters to this day. In fact, he adds, that attitude prevails in some parts of the commercial IRB space; some of the people who started commercial IRBs in recent years came from academic and hospital circles.

Coast’s prices, says McDaniel, have not gone up in three years. It was so important to McDaniel to keep prices stable that he moved the company from Southern California to Colorado Springs, Co., last year, where overhead is lower. Coast has 58 employees, and is soon to hire about 15 new ones.

McDaniel, who suffered a life-threatening head injury while ice skating with his kids last fall, isn’t as involved in the day-to-day operations at Coast anymore. Instead, he’s spending more time pursuing theology studies and writing a book. But he’s still Coast’s idea guy, penning passionate white papers and posting them on the IRB’s website. For him, clearly, it’s more than just a business.
—by Suz Redfearn