The fate of a potential blockbuster drug or medical device can hinge on submitted clinical study data. And that takes lots of suffering patients willing to be guinea pigs.
Yet, for many years, recruiting clinical trial participants was a low-key, generally inefficient process. Medical companies often relied on a network of doctors, known as investigators, with whom they had worked in the past and could be trusted to bring in enough qualified patients.
Ten years ago, Frank and Linda Kilpatrick, with a background in advertising and public relations, decided to launch an El Segundo consultancy to bring a little Madison Avenue to the task.
Today, Healthcare Communications Group is among the oldest and best known firms in the country offering patient recruitment services with the stakes higher than ever.
Recruiting the right mix of patients can save a drug company nearly $1 billion and a decade of effort on a drug that doesn't pan out. That's critical for products with often limited patent protection. Moreover, regulators have upped their scrutiny of experimental therapies in the wake of several high-profile disasters, such as Merck & Co. Inc.'s arthritis drug Vioxx, which was recalled in 2004 after it was linked to thousands of heart attacks.
"Our role is to help companies bring their products to market more quickly, efficiently and safely," said President Frank Kilpatrick, whose company's client list has included such heavyweights as Thousand Oaks biotech giant Amgen Inc. and Pfizer Inc. in New York.
The difficulties of putting together clinical studies are documented.
Clinical study industry tracker CenterWatch estimates that nearly 50 percent of trial delays result from patient enrollment problems, and 86 percent of all U.S. clinical studies fail to recruit the required number of subjects on time. For specialty or blockbuster drugs, delays completing a study can translate to $288 million in potential annual lost revenue.
Drawing on the Kilpatricks' advertising and marketing background, HCG has developed an expertise in how to draw in potential patients. For an experimental Alzheimer's drug, it might place a spot on a morning radio talk show in Philadelphia, or it might work through a medical association. For a diabetes study, the best method might be tapping a patient advocacy group.
With just 5 percent of the U.S. population willing to participate in a clinical trial, it's also increasingly meant looking outside the country for trial participants. HCG, which has another U.S. office in Philadelphia, has opened offices in London and Singapore, and is considering expanding into India and China.
Ken Getz, who founded and later sold CenterWatch, said the kind of direct-to-consumer advertising that is the forte of HCG has become less effective in recent years as the drug industry used more and more advertising to attract patients.
Horror stories about clinical trial problems haven't helped. But there is still a place for a well-run firm that can get patient populations to drug companies.
"That means companies like HCG that are very flexible and nimble, and use a variety of techniques, have an advantage over companies that rely on one method to recruit enough patients who meet a study's criteria," said Getz, now a senior fellow at Tuft University's Center for the Study of Drug Development in Boston.
Indeed, the field of clinical trial recruitment has become more competitive over the years, with even PR giant Fleishman-Hillard opening its own clinical trials division. More often, HCG competes with specialty firms like suburban Philadelphia Acurian Inc., which touts a national database of patients willing to participate in studies.
There wasn't that level of competition when the Kilpatricks decided to start their agency in 1998. Their ad agency occasionally took on clients who were conducting clinical trials, and they felt that there was an untapped market to provide their services to more drug and device makers.
"Sometimes clinicians developing a study undervalue the logistical challenges of participating in a clinical trial, and potential participants might not receive a clear picture about the benefits and risks of participating in a trial," Frank Kilpatrick said.
The Kilpatricks launched the company with their own money and to date haven't sought outside investors. Frank Kilpatrick said they may eventually look to strategic alliances or some other type of partnership to better grow operations overseas.
So far, the company has built up its business fairly well on its own. It has 40 employees and revenues are in the millions; the company declined to release figures publicly.
HCG continues to grow its expertise in a variety of therapeutic areas, including Alzheimer's disease, insomnia, epilepsy and chronic pain. In diabetes alone, the company has assisted in more than 100 studies.
"We have a very in-depth medical advisory board, because you have to understand the disease and the patient population before you can a launch a media campaign," said Dr. Kate Zhong, the company's chief scientific adviser.
Suzanne Steinberg, a Pfizer psychologist who oversees clinical trials for the New York-based drug company, said she can attest to HCG's expertise. Over the past eight years, she's worked with the company on recruitment campaigns for studies of everything from obesity to dementia.
"What's great about them is that they're willing to reinvent themselves and they're very customer focused," Steinberg said. "They'll research and get up to speed on a therapeutic area so they can talk intelligently with our people."
Healthcare Communications Group
Headquarters: El Segundo
Core Business: Helping drug makers attract clinical trial participants
Employees: About 40
Goals: To expand its overseas operations, possibly in India and China
Driving Force: Desire of drug makers to conduct clinical trials accurately and efficiently to get products to market quickly
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