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Calling all clinical research personnel

Monday, October 23, 2017

The Pulse on Global Trials by Matthew Howes

In recent years, a global talent shortage has hampered strategic growth for many organizations. According to the ManPower Group, 36% of employers globally report talent shortages, the highest in seven years.

Clinical trial research is not immune to this difficulty. In fact, the shortage of experienced personnel in CROs is one of the main obstacles the market faces in the coming years.

In the last six years, pharmaceutical and biotech companies removed roughly 150,000 jobs from their workforce as they shifted more R&D activities to CROs. But as the pace of outsourcing has driven growth in the CRO market, CROs are finding themselves with insufficient personnel to fulfill the R&D demands of their clients.

The talent shortage is a problem both here in the U.S. and worldwide. The World Health Organization (WHO) estimates clinical shortages in 83 countries. With more trials being conducted outside of the U.S. than inside, as tracked by ClincalTrials.gov, this represents a very real set of challenges for clinical research.

For emerging markets like Brazil, India and South Africa, it is a chicken-and-egg scenario; some argue that lack of investment leads to shortages of trained clinicians. Others argue that the lack of appropriate resources limits decisions to make necessary investments. According to Professor Mary Gospodarowicz, University of Toronto, economic brain drain may be “the cause of personnel shortages, but a lack of investment in jobs may indeed be a stronger driver of shortages.”

In developed countries like Japan and Canada, shifting demographics of clinicians, who skew older and will soon be retiring, is the leading challenge. In oncology, for example, roughly 20% of cancer specialists are over the age of 64 and less than 20% are under 40, according to numbers published by the American Society of Clinical Oncology (ASCO).

While external forces like an aging workforce and lack of investment in education are contributing to the problem, what about internal factors that industry has more direct influence over? To answer this question, I conducted a survey of trial researchers from Germany, the U.K. and France to explore perceptions and attitudes on the future of clinical trial research. The results were compelling.

The first key finding of the survey was that attitudes toward clinical trials are strikingly negative. Sixty-nine percent of respondents say clinical trial research is bureaucratic, time-consuming, expensive and challenging. Only 31% of the respondents ranked clinical trial research as innovative.

That so few respondents ranked clinical research as innovative is problematic. Research has typically attracted clinicians who are at the forefront of innovation. If investigative work is viewed more as a hassle than a way to be on the leading edge, the industry may soon face a loss of existing investigators who make drug development possible. Losing talent in research could also have a negative impact on early adoption, as investigators tend to be opinion leaders and influencers who are willing to bring new therapies into their practice.

The shortage of physicians will have more far-reaching impact on the world than just research. Last year, ASCO estimated that the demand for cancer care services will double in the next decade, but the number of oncologists will only grow by 28%, leaving a shortage of nearly 1,500 physicians. With the increased demand on their time, physicians will need a clear and compelling rationale for participating in clinical research. Innovation should be one of the most important reasons.

The second key finding was that there are very real barriers to future participation in clinical trials. Reasons why clinicians may discontinue participation in the future include the inability to recover incurred costs, increased difficulty recruiting patients, increased risk exposure, too time consuming and ethics board review requirements. All of these barriers are internal ones that the industry has direct influence on.

Facing increasing cost pressures, sponsors have created an environment that requires more from individual sites with no upside. Investigators have to consider a number of realities when electing to participate. Insurance requirements alone are significant. The combined costs of insuring for malpractice, breach of contract, loss of data and trial-related risks may become cost prohibitive and a disincentive for qualified investigators. As more sites start to operate at a loss, the entire industry is in jeopardy of aggravating the human resource shortage by creating more barriers than motivators.

So what can be done? The industry has to create more connections within and without. By creating linkages between clinical and commercial arms of the sponsor organization, and between internal and external stakeholders, industry can create protocols that make it easier for clinicians to source patients. Working with governments, industry can standardize contracting and ethics board requirements to reduce the burden on practitioners. Most importantly, industry needs to talk more internally and externally about the link between research and clinical care.

As the number of trials continues to grow, recruiting criteria become more specific, and burden of clinical trial participation increases, the ability to attract qualified investigators should the top priority. 

 

Matthew Howes is executive vice president, Strategy & Growth for PALIO, an inVentiv Health company. A leader in digital strategy, he has provided the fuel for digital businesses visited by more than 100 million people every month. Email matthew.howes@inventivhealth.com.

This article was reprinted from CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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