Working in an industry for so many years, it is easy to lose sight of the environment in which your industry operates.
The clinical research industry is a good example. The average CWWeekly reader has multiple years of experience and likely is well versed on the latest industry happenings.
Based on that, it is safe to assume most of us are accustomed to the regulatory hurdles we must overcome in our daily work lives. Yet, when you compare the clinical research industry to other industries, it seems as if it takes longer to get things done, there is more red tape involved, progress is slow and improvements are hampered by the fear of moving forward.
Because many industry veterans have gotten used to long approval times and red tape, and simply consider it business as usual, the reality of regulation dashes their dreams of innovative technology that can make processes more nimble and quick. Brilliant ideas are shot down in flames, because in a mega-regulated environment you just can’t easily implement a good idea. After you recover, you may decide you fear the flame and choose to keep your brilliant ideas at bay. After all, what good is an idea if you can’t readily act on it? The clinical research industry is the second most regulated industry in the world, second only to the commercial nuclear industry. A quick comparison of the two reveals surprising similarities that hamper the adoption of technological innovation.
The Nuclear Regulatory Commission (NRC) is an official independent agency of the U.S. government. Its role is to protect public health and safety related to nuclear energy. Likewise, the Food and Drug Administration (FDA) is an agency of the U.S. government whose role is to protect and promote public health by regulating food and drugs. Similarities between the two include self-awareness that modernized reforms are necessary, and both agencies have received similar criticism that major deficiencies exist. In addition, both agencies may be textbook cases when it comes to “regulatory capture,” a theory depicting the process of a regulatory agency becoming dominated by the very industry it is charged with regulating. Whether or not this actually is the case is not
In an environment where lengthy regulated processes and the perception of mistrust exist together, innovation and efficiency are the real losers. In both industries, the regulations exist to prevent harm and protect the public health. When the regulations developed to protect us end up doing more harm than good with lengthy procedures that impede progress, it may be time to overhaul how we regulate industries that protect the public.
Clinical research studies rarely are completed on time, an industry fact for many years. Why do clinical trials take so long, and what efficiencies can we make under the current regulations? Take a look at some of the factors that often cause delays from a clinical research site’s perspective. (see chart)
We all want to move forward, and many of us have lofty—yet valid—process improvement ideas that could lead to operational excellence in the clinical research industry. While this is a worthwhile goal and should be applauded and encouraged, it may be easier to obtain a license application to propose a new nuclear reactor.
Ashley Tointon directs patient engagement programs at ePharmaSolutions, combining traditional methods with innovative, data-driven techniques to provide sponsors high-impact, cost-effective recruitment and retention programs. She has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry.
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 »