By Deborah Borfitz

December 16, 2008 | The fundamental problems facing the clinical trials enterprise in 2009 are the same ones that have been plaguing it for years, industry insiders say, including lagging productivity and overly complex study protocols that impair patient recruitment and extend development timelines. Rather than seek meaningful, long-term solutions, companies tend to take shortsighted corrective action to quickly sweeten the bottom line.

The nation’s ongoing economic turmoil is also threatening the pharmaceutical industry with “unfamiliar challenges,” says Ronald Waife, president of Needham, Mass.-based clinical research consultancy Waife & Associates. Long discovery and product cycles have traditionally shielded pharmaceutical companies from the realities of layoffs and facility shutdowns that they’re now being forced to confront.

Odds are good that companies will be looking at their targeted therapeutic areas with a more discerning eye, says Lauri Sirabella, VP clinical strategic business development for Philadelphia, Penn.-based recruiting company ExecuPharm. Pfizer, which has its Lipitor patent expire in the next few years, has decided not to pursue development of any other cardiovascular drugs. Besides looking at their core competencies, companies will need to consider which therapeutic areas will have the greatest demand for treatments based on worldwide population, age, and disease trends.

Many companies will move into oncology, which has strong potential growth, says Sirabella. There are also many promising leads to chase down, including starving or treating tumors rather than removing them.

On-Shoring

In 2009, many companies may start to consider on-shoring rather than off-shoring operations, says Waife. Not only has the recession evened out currency exchange rates, but Americans want to keep jobs at home for reasons of patriotism, convenience, and economic necessity. There is also tremendous pressure on the new Obama administration to bring jobs back on shore.

Furthermore, off-shoring can be an impractical course for reining in costs, says Waife. “If you can’t manage people in the next cubicle, why try to do it across the Pacific Ocean? Long-distance management problems are enormous because of the lack of face time as well as language and culture barriers. The meaning of ‘yes,’ ‘deadline,’ ‘completeness,’ and ‘quality’ all have [unique] cultural definitions. All of that can be overcome with project management, but it’s hard to do ten time zones away.”

Off-shoring havens also quickly lose their “salary advantage,” as is now being proven in India. “No short-term financial advantage will ever be permanent,” says Waife. “If you find a cheap source of something, there will be high demand for it and the price will rise. Playing games with global macroeconomics is a bad idea. Plus, outsourcing overseas gives people another reason to dump on pharma these days.”

Sirabella agrees, adding that the employee turnover rate in India is high, further escalating costs. The situation in India is beginning to stabilize, as it is in China, she adds. But there are many pockets in the U.S.—Kentucky, Tennessee, and Alabama among them—that are equally economical locations for setting up clinical research and data management facilities. Companies could further save on overheads by having study managers and other employees work remotely from home or other nearby location and only come on-site as needed. “Companies have to become more comfortable managing employees that way.” Currently, it’s an accepted practice only for study monitors.

In partnership with ExecuPharm, Pfizer has successfully implemented the first extensive remote study management model—covering more than 300 employees in the U.S. and another 50 in the U.K.—by seeking people with “excellent communication skills who are proactive about preventing problems and handling them when they arise,” says Sirabella, who formerly headed up study and data management at Pfizer’s R&D facility in New London, Conn. “Most of what study managers do is electronically based today. They don’t have to be in the building to interact with people and manage a clinical study.” Virtual employees also broaden the talent pool that organizations can tap in less desirable geographic locations, including New London (Pfizer’s U.S. headquarters).

It’s highly unlikely that there will be any slowdown in the globalization of clinical trials to Latin America, South America, Asia, and Eastern Europe, says Sirabella, largely because of the ready availability of trial volunteers who don’t have good access to medical care. The sheer volume of oncology trials has also made recruitment quotas hard to fill in the U.S.

Outsourcing will continue unabated for the next five to ten years, predicts Sirabella, because it is difficult for companies to own staff in economically volatile times. There is plenty of competent talent for sale, as key leaders and much of the staff at contract research organizations and other vendors are former pharmaceutical company employees.

Suggested “Resolutions”

If companies resolve to do anything this year, ending internal “partisanship” would be a good place to start, says Waife. Notions about who is right and who is wrong can take on almost religious proportions at some organizations. “Between departments there is [mutual] mistrust and even disrespect.” If lasting change is going to happen, it may first be necessary to reorganize the power grid to accommodate cooperation.

“You can’t really work together if you have fixed ideas,” says Waife. Heroic stories about how everyone pulls together to get a submission out to the Food and Drug Administration at the last minute conveniently overlook the inefficiency that prompted such valiant action. “Heroes are formed in battle and the battle goes on.”

Weak executive leadership, fearful of losing talent, only adds to the partisanship problem, says Waife. Pharma executives have not had to experience adverse circumstances such as today’s financial, operational, and public perception problems, and have little training in dealing with difficult decision making. “[They] don’t know what to do about it. They want it to go away or want people to make nice with each other.”

Inexperienced leaders look for quick fixes, which Waife views as a sign of their boredom with operations. “It may be legitimate that the most important thing they can do is acquire a product for the pipeline that is nearer to market [than anything in the existing portfolio], which results in sales and profit their shareholders are looking for.” That doesn’t mean they can be cavalier about operations. “Operational inefficiency is rampant and wastes a lot of money and time and that, too, has an impact on sales and shareholder value.”

A second ideal New Year’s resolution would be for companies to be more introspective. Why, for instance, do they ask so many questions during a clinical trial that don’t have relevance to proving or disproving the endpoint? Why does a particular workflow process have seven steps rather than two? And why are there multiple cycles of quality checking in every department?

Forward-thinking companies will probably want to start paying attention to the social networking movement, says Waife, pointing to President-Elect Obama’s fund-raising efforts due to his virtual presence on MySpace and Facebook. The “anarchic principles” of social networking are not a good fit with the scientific method, but these sites may well have applicability in the notoriously knotty area of subject recruitment.

A “radically different” clinical trial management system (CTMS) would also better suit the industry than the current, “impossibly over-featured” spoke-and-wheel platforms for exchanging information that serve no user type particularly well, says Waife. Like it or not, pharma research happens in silos and each of those disciplines “deserves a tool that serves their operational excellence.”

It’s not that integration isn’t important, adds Sirabella. One of the most helpful features of a CTMS, which surprisingly few systems have today, is the ability of its component databases to share information with each other.

This story first appeared in eCliniqua, one of Bio-IT World’s free eNewsletters. Subscribe here.