The Clinical Trials Issue

In an editorial, published Online First, in advance of print in the October 25, 2007 printed issue of the journal New England Journal of Medicine, a trend in the pharmaceutical industry, wherein contract research organizations (CROs) increasingly conduct academia’s customary drug development role, came under the kliegs1.The activities of theses CROs, which offer speedier and more efficient clinical trials than academic departments, are under increasing scrutiny, in particular, their competencies, qualifications, and regarding autonomy from their clients in the pharmaceutical industry, and issues of answerability.

According to the editorial, CRO-industry annual revenues have soared from about $7 billion in 2001 to a projected, $17.8 billion currently, Quintiles, Covance, Pharmaceutical Product Development (PPD), and Charles River Laboratories, the four biggest of the over a hundred such firms in the U.S., now billion-dollar firms, two others, Parexel and MDS Pharma Services, worth over $500 million each. No doubt, CROs are making great strides with regards clinical trials. Indeed, a study the Tufts Center for the Study of Drug Development conducted under the aegis of the large CROs found that 10 of the largest CROs had enrolled over 640,000 subjects in clinical trials in 2004 alone1. The clinical-trials information company Thomson CenterWatch, also noted that CROs were active in 64% of phase 1, 2, and 3 clinical studies in 2003, roughly $7.6 billion in contracts, versus 28% in 1993, about $1.6 billion in contracts1.

Yet, concerns have started to emerge especially subsequent to some recent events regarding the activities of these CROs, and the commercialization of clinical trials, as it stands, vis-à-vis the public interest and of that of scientific progress. For example, the NEJM editorial noted that in 2005, a Bloomberg News report showed that conditions at a phase 1 and 2 clinical-trials unit at a converted Holiday Inn in south Florida owned by the SFBC International CRO were inadequate, and oversight almost nonexistent, the trials director, a doctor, had no license, and many of the research subjects in Florida, poor Hispanic immigrants lured by per-trial payments, not fully aware of the risks involved in the trials1. The editorial observed “At an SFBC site in Montreal, a patient was allowed to remain in a trial despite having active tuberculosis; nine other trial participants later tested positive for the disease. The company, now called PharmaNet, shut down its Florida site and settled a resulting shareholder class action lawsuit for $28.5 million in August 2007.”1

The editorial also noted that human subjects were seriously injured in 2006 at a phase 1 trial in Britain that the CRO Parexel managed during which the organs of six assigned to test a monoclonal antibody developed by the German company TeGenero, out of eight healthy male volunteers, started failing necessitating intensive care for the affected men. Inspectors for the British Medicines and Healthcare Products Regulatory Agency not only discovered that a Parexel doctor involved in the study had inadequate training and experience but also that the firm itself lacked a formal system for 24-hour medical coverage in place, although the expert scientific group that probed the case for the British Secretary of State for Health concluded that these problems “highly unlikely” were responsible for the events. 

Could the stress on speed at the expense of quality, dated drug regulations, three decades old, put together about ten years prior to the emergence of the contract research industry, hence unsuited to deal with its accountability, among others be the culprits for these problems, and do we therefore need new regulations? Do these issues not raise those concerning revisiting entirely the clinical trials issue given some others related and remote, problems surrounding it, for example those involving even researchers in the academia and their ties to the pharmaceutical industry, and those concerning the approval process by bodies such as the US Food and Drug Administration (FDA) for examples, particularly increasingly in recent times? That the FDA announced on October 04, 2007, that it intends to implement some changes to speed the approval process for generic drugs and reduce a backlog of over 1,000 generic drug applications, is perhaps an attempt to tackle some of these issues2.

 

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