Ghost in the Machine
INSIDERS CALL them a necessary evil, spawned by an industry that has itself been cast as the devil. “I prefer to call us the ghost that provides pharmaceutical companies full-service management of clinical trials,” says Paul Keown, founder of Syreon Corp., a Vancouver-based contract research organization (CRO) that has capitalized on the increased industry outsourcing of drug testing. “Clinical trials take a lot of time, money, effort and scrutiny so we try to take away those hassles, from ethical approval to safety monitoring to meeting with regulators like the FDA [U.S. Food and Drug Administration] so that a drug can be approved.”
The public is largely clueless that temps are now key figures in the long, bumpy and occasionally deadly process of getting a drug from the lab to their medicine cabinets. That process typically takes about 15 years and costs as much as $1.2 billion, with only one in 5,000 drugs making it to market. That’s if it makes it past the human trials phase. The average clinical trial takes 780 days to complete, from initial protocol design to trial close-out, and typically costs a pharmaceutical client about $2 million to $3 million, according to Keown. Even then – after the involvement of hundreds of researchers and volunteer patients – fewer than 10 per cent of drugs will make it from clinical trial to market.
Managing such a trial involves budgeting, contract negotiations, the ethical approval necessary to green-light a study, physician and patient recruitment, site monitoring, data collection (everything from basic demographics to blood tests to measurements of adverse drug reactions) and meetings with sponsors and regulatory officials. Outsourcing this ordeal to a private firm can speed up the process by 30 per cent, according to one industry estimate. That means less time to get the drug to market, which means more market revenue potential for a drug-maker. Keown says a Syreon-run project cuts costs by 10 to 20 per cent compared to a pharmaceutical company’s in-house trials or those conducted at universities or hospitals, saving up to $500,000 on average.
Canada has become a hot spot for clinical trials because we offer a rare combo of world-class medical resources and researchers and cost savings. As of 2004, it was 22 per cent cheaper to run a trial here than in the U.S., according to a report by KPMG International, a Swiss-based auditing firm that ranked us number one in the world for cost savings. As I write this, pharmaceutical companies are conducting some 30,000 clinical trials around the globe; the majority are part of multi-centre trials involving dozens to hundreds of “investigational sites” around the globe. Canada has the third-highest volume of trials at 3,180, after the U.S. (15,933) and Germany (3,461), while in B.C. there are currently 1,726 trials underway.
“Over the past 60 years, there have been many shifts in drug testing methods,” says Keown. The process has evolved from small in-house trials in the 1950s to innovative drug development programs built by university- and hospital-based researchers in the 1960s (primarily with government funds) to today’s preferred model of patchwork multi-centre trials, which started in the 1990s and relies primarily on community-based doctors testing drugs on their patients. Both in-house and academic drug trials are still conducted, but industry has downsized R&D departments while the number, complexity and expense of drug trials has increased with what Keown calls “a focus on blockbuster drugs” and what watchdogs peg as Big Pharma’s obsession with profits. Full-service CROs have sprung up to fill in the gap.
Big Pharma now outsources approximately two-thirds of its clinical trial management to more than 1,000 CROs around the globe. These CROs were the recipients of about US$17 billion of industry R&D spending in 2007, with annual spending growing by an estimated 15 per cent. In Canada clinical trials accounted for about 40 per cent of the $1.3 billion spent on R&D in 2007. The majority of CROs operating in Canada are large U.S. multinationals, with each of the global top 10 – among them, Quintiles Transnational Corp., Covance Inc. and Kendle International Inc. – now having branch offices here. Only five are Canadian-owned, including B.C.-based Syreon and ASKA Research (headquartered just down the hall from Syreon). While Syreon primarily works directly for Big Pharma, ASKA has forged partnerships with CROs based in other countries that are looking for cross-Canada links to our researchers, doctors and patients.
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