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.
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