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Staffing Multinational Trials
A Time for Creative Solutions
In the past decade, an unprecedented push to field Global clinical trials has boosted the demand for patients and CRAs from Asia to Zambia. Sponsors expect rock-bottom pricing, transparency, local staff with a breadth of experience, and a high level of service. Yet one of the greatest challenges today is attracting and retaining quality CRAs worldwide. According to Bill McHale, President of i3 Pharma Resourcing, while new clinical research professionals bring refreshing energy and ideas to their work, customers demand experience. Most sponsors, and thus their contract research organizations (CROs) and staffing providers, will not accept researchers with less than two years of experience. An i3 Case Study on Creative Staffing While customers would prefer not to solely bear the burden of paying for training, they are beginning to recognize their need to join forces in an effort to replenish the funnel of qualified clinical-research professionals. i3 Pharma Resourcing runs a six-month partnership training program for new graduates and those returning to the industry. Those who undertake this apprenticeship do theoretical and practical course work, including on-the-job experience with pharmaceutical companies. At six months, the sponsor begins to pay the apprentice for junior-level work, so that inside of two years these new researchers are ready to work on their own. In running this program for 18 months in Australia and the United Kingdom, 16 of 20 candidates have graduated into full-time roles with pharmaceutical companies, and additional sessions are scheduled for the fall in both countries. Pilot programs in other countries are planned to begin in the next several months. Global Scarcity For many years, conducting clinical trials in naive geographies meant that the trials would be less expensive. Today, however, countries rife with untouched patient populations are not necessarily a match for where experienced clinical researchers live and work. In fact, most areas outside the United States have a dearth of skilled staff across industries. A 2004 report by the U.K.-based Recruitment and Employment Confederation showed a growing skills shortage. It concluded that employers were offering substantially higher pay rates to attract the right candidates and that this escalation had no end in sight. Indeed, the industry is experiencing these bidding wars firsthand. As R&D timelines are shortened and pressure mounts to bring products to market sooner and at a lower cost, the pressure is on to conduct efficient clinical trials with high levels of service and accountability. While the work is plentiful, the workforce is not. This CRA candidate scarcity is a prevailing problem the world over. The United States boasts the greatest workforce, but even here CRAs can name their price. Pay creep has led to a pay run, affecting the bottom line of clinical trials for biopharmaceutical companies and their outsourced partners. Western Europe is in a similar staffing situation. For instance, in March PharmiWeb in the United Kingdom had 217 posted vacancies for CRAs with two-plus years of experience but only 32 active candidates on their site. Australia has a proportionate population of researchers who are able to work at a very high level and at reasonable cost, but the patient population is small there. In some countries, such as India, the few qualified candidates go to the source willing to pay the most. India is experiencing increased demand for local trials from across the globe. Today the labor is less expensive, but with only an estimated 1,500 clinical research professionals, the service delivery and quality may lack consistency. An insatiable demand for researchers in India will eventually drive people into this career field, especially since the demand for capable researchers is leading to a doubling or even tripling of the pay scale. A large number of students already are entering universities with an eye on the research field; many doctors, seeing the financial advantage, are shifting into this niche. But there will be a void for the next several years until the population of researchers catches up to the demand. In a world where supply is limited, demand will drive up the cost of trials, and the price of medicines will continue to rise. It is incumbent on all the players to recognize the current finite number of skilled researchers. As the industry demands more trials in remote world regions, with a goal of producing effective, affordable drugs, companies can encourage people to enter and stay in the research fields in a number of ways, such as: adding flexibility — The role of a CRA is demanding. Based on the precision needed for detailed reporting and compliance, a CRA’s job may require them to travel 60% to 70% of the time. In the United Kingdom, upward of 70% of CRAs are women, who may be less interested in traveling or even working in an office environment. Many companies are providing CRAs with more work-life balance, basing them regionally or at home, and allowing part-time or flex-time options. While these options are attractive, they are not a panacea and may still leave the outsourcers challenged to meet their commitments. Retrofitting people with similar skills into research — Good project managers in another field may transition nicely into research. For instance, project managers from the IT sector with years of experience managing complex projects and matrixed teams could be compelling industry converts. Additionally, India’s 225,000 physicians will recognize that they can increase their salaries as CRAs. Similarly in Eastern Europe, physicians who earn $14,000 per year can increase their salaries up to $25,000 a year as clinical research professionals. attracting more people into the industry — A number of university programs now include accreditations in clinical research, separate from a nursing degree. With one of these certifications, new researchers can count some of this course work experience toward the two years that most sponsors and CROs expect, particularly if they are able to combine course work with practical work experience as part of their curriculum. We in the industry must seek win-win opportunities to encourage new researchers to join the field. The CROs and staffing entities cannot fix this problem alone. When sponsors become collaborators in the intake and development of new researchers entering the field, we can create solutions that benefit us all. Relaxing the two-year minimum work experience requirement and agreeing on solutions to “build” new employees together would go a long way toward that goal. PharmaVOICE welcomes comments about this article. E-mail us at firstname.lastname@example.org. September 2006