Medicare Encyclopedia Entry
Graham Ellis
Definitions/Background
A Contract Research Organization, or CRO, is an institution that is hired by representatives in the pharmaceutical, biotechnology and medical devices industry to perform various research functions on a contract basis (PPDI.com). Specifically, these organizations often specialize in services such as clinical research, commercialization and clinic trials management. Aside from privative institutions, Contract Research Organizations can also represent federal agencies, universities and research institutions. CRO’s are most often used for the development and management of clinical trials that help move a new drug or device from its conception to FDA approval and entry into the marketplace (PPDI.com). Pharmaceutical companies typically outsource this work to CRO’s in an effort to save time and money; hiring specialists with a built in infrastructure for managing drug trials saves the pharmaceutical company the money it would take to hire a trial staff and undergo the trials process. While the Contract Research Organizations are responsible for many of the services surrounding the development of new drugs and their trials, the independent sponsor, or the company paying the CRO, is ultimately held responsible for the quality and integrity of the clinical trials (Retig, 132).
Since their conception, Contract Research Organizations have become a vital component of the drug and technology development process. The industry itself didn’t begin until about a decade ago, and now, it is one of the most successful sectors of the economy. CRO’s allow pharmaceutical companies to develop drugs for smaller niche communities and to get drugs to patients more quickly.
Historical Context
It is impossible to understand the rise of Contract Research Organizations outside the historical context in which they were created. From the year 1986 to 1998, the budget of the National Institute of Health for Research and Development has increased from 5,401 million to 13,648 million (Retig, 132). Similarly, the budgets of private pharmaceutical companies based in the United States have increased their research and development budget from 3,875 million to 17,223 million (Retig, 132). In the United States, the sale of pharmaceutical drugs increased for an average of 11% per year from the years 1970 to 1999 (Retig 133). The nation’s continuous and sustained investment in scientific and biomedical research has created an industry that is “ripe for exploitation,” (Retig 133). While this massive investment is occurring, the Prescription Drug User Fee Act in 1992 has greatly reduced the amount of time needed for review of a new drug under the FDA. Similarly, globalization of the medical industry and the need to make drugs more affordable in other countries has put pressure on Pharmaceutical companies to increase efficiency and to lower costs on drugs (Retig, 134). Throughout this process, Contract Research Organizations provided a way from pharmaceutical companies to produce more drugs at a faster rate, and therefore, the industry has boomed. In the 1990’s, it is estimated that approximately 5 to 8 billion dollars of Research and Development occurred through CRO’s (Retig 134).
Controversy/Perspectives
The arrival of Contract Research Organizations forming their own industry within the world of medicine has created several high-profile controversies that both highlight the effectiveness of these organizations while emphasizing the need for regulation of this new industry (Martin). Contract Research Organizations are a relatively new industry (most have been formed in the past decade and a half), and the sheer speed of development of the industry left room for a lack of regulation and control. Regulation is incredibly important in regards to Contract Research Organizations as they directly involve the safety of the subjects of human trials and can determine what drugs are depended upon in the marketplace (Martin). While not directly involving CRO’s, several controversies surrounding clinical trials began to appear in the 1990’s. First, in 1998 and 1999, the clinical trials of several drugs at major institutions such as Duke University and The University of Chicago were temporarily put on hold due to issues with the Institutional Review Board system (IRB), which was designed to regulate clinical trials (Rettig). Next, in 1999, the New York Times wrote an article examining the ways in which physicians were paid to recruit clinical trial subjects, and the ways clinical trial findings could be manipulated to boost physicians’ salaries. Also, the speedier turn-around time for the approval of new drugs (partly due to the rise of CRO’s) caused many to question whether the FDA was monitoring the process adequately, since many drugs had to be recalled from the market (Rettig). However, the FDA’s response stated that the vast amount of new drugs on the market often caused physicians to misprescribe their patients. Finally, the manipulation of trial data caused a media frenzy when a British pharmaceutical company attempted to suppress trial data that debunked its claims about its new drug (Rettig). While these rather large controversies have marred the reputation of clinical trials and Contract Research Organizations, as a whole, they have lead to more treatments being made available for more people that need them (Martin).
Relation to Politics of Health
Finally, the development of Contract Research Organizations, and the clinical trials industry as a whole has several connections to the politics of health. Most importantly, clinical trials force policy-makers to examine what exactly constitutes a person’s “informed consent,” and how ethical are recruiting practices of CRO’s the enlist subjects for clinical trials (Fisher). Informed consent is defined as permission being granted in the knowledge of the full list of possible consequences that may occur as a result of the trial (Fisher). Contract Research Organizations often emphasize their incredibly rapid subject recruitment time to private pharmaceutical companies and public institutions as well of gaining business. However, several public health professionals criticize recruitment techniques such as advertising to particular populations of people to appeal to their desperation (Burgess, Sulzer). Many in the field of public health now argue that informed consent is now not enough, and that CRO’s and other organizations conducting clinical trials should not be allowed to target particular populations (Fisher). Economic conditions can create incentives for subjects to participate purely for economic gain, and others may be more prone to participating because of terminal illness (Fisher). These larger societal structures put certain populations at higher risk of participating in clinical trials, and policy-makers are now facing the task of regulating the recruitment of individuals for clinical trials (Fisher). Similarly, the issue of pharmaceuticalization played a key role in creating the need for Contract Research Organizations. Americans, and patients as a whole, are now more than ever desperate to receive medications for an expanding number of illnesses, putting pressure on the pharmaceutical industry to speed up drug trials (Williams, Martin, Gabe). Contract Research Organizations are found right at the intersection of ethics and an expanding pharmaceutical industry, and policy-makers will likely have to increase regulations on these companies in the future.
Citations
PPDI.com. “CRO Overview,” Accessed on February 19, 2017. http://www.ppdi.com/About/CRO-Overview
Jill Fisher, “’Ready to Recruit’ or ‘Ready to Consent’ Populations? Informed Consent and the Limits of Subject Autonomy,” Qualitative Inquiry 13 (2007): 875-894.
LJ Burgess and NU Sulzer, “The Role of Print Advertising in Clinical Trial Recruitment: Lessons from a South African Site,” Open Access J Clin Trials 2 (2010):83-87.
Greg Martin, “Clinical Trials: Innovation, Progress and Controversy,” HHS Public Access 3 (2011): 43-44
RA Rettig, “The Industrialization of Clinical Trials,” Health Affairs 19 (2000): 129-146
Simon J. Williams, Paul Martin and Jonathan Gabe, “The Pharmaceuticalisation of Society? A Framework for Analysis,” Sociology of Health and Wellness 5 (2011): 20-47.
« Back to Glossary Index