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Research industry's trends beget more challenges for trial sites
CT globalization key part of change
The last five years have been tumultuous years for the clinical research industry due to the global economic downturn and other trends that are dampening revenues, experts say.
"There's a looming patent cliff," says Ken Getz, MBA, a senior research fellow and assistant professor at Tufts Center for the Study of Drug Development at Tufts University in Boston, MA. Getz also is chair of the Center for Information and Study on Clinical Research Participation in Boston.
"The engine that delivers resources invested in research and development (R&D) has been under attack by generic erosion, softer consumer demand in a down economy, and the introduction of products into the marketplace that are targeting smaller markets," he explains.
Sponsors are losing their blockbuster drugs as patents run out and few drugs can replace these, he adds.
"It's forced sponsors to re-evaluate how they can optimize every dollar they spend on R&D, and it has direct translation into the clinical trials arena," Getz says.
This means the clinical trial (CT) business is becoming harder for sites, says Norman M. Goldfarb, CRCP, managing director of First Clinical Research, editor of the Journal of Clinical Research Best Practices, and chair of MAGI – the Model Agreements and Guidelines International, all in San Francisco, CA.
"When the economy went down in 2009, the clinical trial business got a lot harder," Goldfarb says. "So it's been a tough environment, and there are some sites that will say 2010 was tougher than 2009."
CT sites feel a lot of the same pain pharmaceutical companies feel, but they experience it in different ways, says Dave Handelsman, senior industry consultant at SAS Health and Life Sciences in Cary, NC. SAS provides advanced analytics to solve scientific and business problems.
"Clinical trial sites are being held more accountable to meeting their milestones in terms of recruitment and quality," he adds.
Research organizations can use business analytics to help them improve their operations. Analytics can help them design better trials, target patient recruitment, optimize operational activities, etc., Handelsman says.
As research organizations plan ahead for 2012, they should take note of these current trends:
There is more focus on CT site data collection: Sponsors increasingly are using site report cards in which they have collected data on sites involved in a study, Goldfarb says.
"They create a small digest and send it to sites so sites can see how they're doing during the study and how they did after the study," he says. "The report card will tell them whether they're in the 57th percentile, and it will give them feedback so they'll do better."
Sponsors and clinical research organizations (CROs) are following the philosophy that you can't manage what you can't measure, Getz notes.
"So there's a real focus on having sites collect start-up metrics, recruitment metrics, and all kinds of metrics around the review and approval of the IRB," he adds.
Since many sites still have very poor recruitment experiences in studies, enrolling one or no subjects, sponsors or CROs might take a look at a site's historical performance before including them in a study, Handelsman says.
"Pharmaceutical companies need to know and collect those metrics," he adds. "Some CROs are more active than others on doing this."
Also, sponsors increasingly are demanding that sites provide more metrics, and they're using these data to better select sites that will be successful in study recruitment and meeting enrollment deadlines, Getz says.
Generic drugs have gained more market share: "The majority of prescription drugs that are sold each year now are generic versions," Getz says.
"These are not just drugs developed in an emerging country, but also drugs for large markets that have now lost patent protection, including drugs for high blood pressure, heart disease, and even some widely-taken drugs for psychiatric illnesses and neurologic diseases," he adds.
As these blockbuster drugs become open to generic drug competition, these competitors are eating into critical revenue streams that the pharmaceutical and biotechnology fields once relied upon, Getz says.
"A lot of treatments moving through the pipeline are also targeting smaller markets, so companies have to figure out how to create a larger portfolio of drugs to recoup the lost sales from the blockbuster drugs that now are generic," he explains. "It's true that they're always trying to diversify their portfolios, but in the past a single successful drug would generate enough revenue to recover costs."
Sponsors need to improve their drug success pattern. They no longer can afford to have only one drug brought to market for every five in clinical research, Getz says.
"That probability of success has to improve because the drugs in the market are not generating enough revenue to cover the high cost of failure," he says. "This is forcing companies to assess how to lower the cost of R&D or accelerate the time it takes to get a drug to market."
Sponsors want greater clinical research efficiency: This trend often translates into cost pressure on CT sites, but it does not solve the underlying revenue problems sponsors face, Goldfarb notes.
"You can use the auto industry as an analogy," he explains. "When it started getting pressure from Japan and Japanese automakers, it decided it had to reduce its prices and costs, and you could do that by negotiating lower prices from vendors."
While that helped, it didn't solve the problem, so the government stepped in when there was a big crisis, he adds.
"So the pharmaceutical industry is still largely in that phase of putting price and pressure on its vendors," Goldfarb says. "It's doing a little bit with partnerships with CROs and partnerships with sites, but these won't solve the problem."
Sponsors are giving CROs greater autonomy because it saves their resources to trust the CRO's site monitoring and to avoid redundant oversight, Getz says.
"The CRO seems to be poised to drive an even higher level of integration and management influence over the site's operations," he adds.
The likely resolution will involve the industry's financial situation getting worse until the industry decides to take dramatic steps, including adopting standards that can save money and time, he says.
"Sponsors have the pressure to develop more products faster and cheaper, so clinical trials need to be faster, cheaper, and have quality data," Goldfarb says.
Globalization of trials will continue: Goldfarb estimates that about half of CT sites and more than half of CT subjects are overseas, especially in developing countries.
"Sponsors are saying, 'If I can get research done overseas with additional costs and headaches, but a lot cheaper then why not do it,'" he says.
"In terms of an overall trend for globalization, my guess is the United States will end up with a 25% market share of clinical trial studies eventually," Goldfarb predicts. "Twenty years ago, 98% of the trials were done in the United States, and that has worked its way down about 2% a year."
This globalization trend likely will continue until it reaches the point where some of the advantages of having trials in the developing world go away, he adds.
"At some point there will be fewer naïve populations, more competition for subjects in those countries, and their costs will go up closer to U.S. costs," Goldfarb says. "It will take a while, and it will be very painful for U.S. research sites, but the market share will stop changing."
Handelsman also predicts a continuation of the globalization trend for clinical trials.
"There's a belief that you can get more patients enrolled in trials overseas," Handelsman says. "There are different costs associated with it and different regulatory issues, but there is a ton of work going overseas, and we won't see that declining soon to any extent."