Commercialisation of Clinical Research

Publication Year: 
2012

Clinical research organizations are a very new phenomenon. Thirty years ago, hardly any existed: Now there are hundreds, with a global revenue of $20 billion in 2010, representing about a third of all pharma R&D spending.9 They conduct the majority of clinical research trials on behalf of industry, and in 2008 CROs ran more than 9,000 trials, with over two million participants, in 115 countries around the world.

This commercialisation of trials research raises several new concerns. Firstly, as we have already seen, companies often bring pressure to bear on academics they are funding, discouraging them from publishing unflattering results and encouraging them to put spin on both the methods and conclusions of their work. When academics have stood up to those pressures, the threats have turned into grim realities. What employee or chief executive of a CRO is likely to stand up to a company which is directly paying the bills, when the staff all know that the CRO's hope for future business rides on how it manages each demanding client?

It's also interesting to note that the increasing commercialisation of research has driven many everyday clinicians away from trials, even when the trials come from the more independent end of the spectrum. Three British academics have written recently of their difficulty in getting doctors to help them recruit patients for a study requested by the European medicines regulator, but paid for by Pfizer: 'Academics wrote the protocols, collaborators are academic, and the study data are owned by the steering committees (on which industry has no say), which also control analyses and publications. A university is the sponsor. Funding is from industry, which has no role in study conduct, data collection, or data interpretation.'10 UK doctors and primary care trusts regarded this study as commercial, and were reluctant to hand over their patients. They are not alone. The Danish Board of medicine regards these kinds of studies as commercial, which means that any practice participating in them must declare the interest, further reducing the recruitment. In the US, meanwhile, the use of private community doctors to conduct trials has expanded enormously, with incentives approaching $1 million a year for the most enterprising medics.11

For a window into the commercial reality of the CRO world, you can look at the way these services are presented when they are being promoted to pharmaceutical companies, and see how far this reality is from the needs of the patients, an any spirit of neutral enquiry. Quintiles, the largest company, offers to help its industry customers to 'better identify, promote, and prove the value of a particular drug to key stakeholders'.12 'You've spent hundreds of millions of dollars and years bringing your product through the drug development process,' it says. 'Now you face multiple opportunities -- and possibly more requirements - to demonstrate safety and effectiveness in larger population.' There are also cases of CROs and drug companies with contracts that hare the risk of a poor outcome between them, increasing the chances of a conflict of interest even further.

These aren't smoking guns. They simply illustrate the banal commercial reality of what these companies do: they find stuff out, of course, but their main objective is to make a company's drug look good so that regulators, doctors and patients will swallow it. That's not ideal in science. It's no fraud either. It's just not ideal.

It would be wrong to imagine that this shift in culture has been driven by a hope that CROs would produce more flattering findings than other options. They are attractive because they're fast, efficient, focused and cheap. And they're especially cheap because, like many other industries, they outsource their work to poorer countries. As the former chief executive of GSK explained in a recent interview, running a trial in the US costs $30,000 per patient, while a CRO can do it in Romania for $3,000.13 That is why GSK aims to move half of its trials to low-cost countries, and is part of a global trend.

In the past, only 15 percent of clinical trials were conducted outside the USA. Now it's more than half. Th average rate of growth in the number of trials in India is 20 per cent a year, in China 47 per cent, in Argentina 27 percent, an so on, simply because they are better at attracting CRO business, at lower cost. At the same time, trials in the US are falling by 6 per cent a year (and in the UK by 10 per cent a year).14 As a result of these trends, many trials are now being conducted in developing countries, where regulatory oversight is poorer, as is the normal standard of clinical care. This raises a huge number of questions about data integrity, the relevance of findings to developed world populations, and ethics - all issues with which regulators around the world are currently struggling.

There are many anecdotal accounts of bad behaviour with trial data in poorer countries, and it's clear that the incentives for massaging results are greater in a country where a clinical trial is paying its subjects vastly more than local wages could match. There are also difficulties with regulatory requirements that fall across two countries or two languages, as well as translation issues in patient reports, especially for unexpected side effects. Site visits for monitoring may be of variable quality, and countries differ in how much corruption is routine in public life. There may also be less familiarity with administrative requirements concerning data integrity (which have been a bone of contention between industry and regulators in the developed world).15

pp. 111-114 Bad Pharma: How Drugs Companies Mislead Doctors and Harm Patients by Ben Goldacre (2012)
Image retrieved from Zytras Pharmaceuticals on September 9, 2014.

Citations

9 ACRO - CRO Market [Internet]. [cited 2012 Feb 11]. Available from: http://www.acrohealth.org/cro-market1.html.

10 MacDonald T, Hawkey C, Ford I. Time to treat as independent. BMJ. 2010 Nov 30;341(nov30 2):c6837-c6837.

11 Kassirer J. On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health. Ch 8. 1st ed. Oxford University Press, USA; 2004

12 Pharmaceutical CSO - Pharmaceutical Commercialization - Quintiles [Internet]. Available from: http://www.quintiles.com/commercial-services/

13 DRUG TESTING GOES OFFSHORE - August 8, 2005 [Internet]. [cited 2012 Feb 11]. Available from: http://money.cnn.com/magazines/fortune/fortune_archive/2005/08/08/826765...

14 Theirs FA, Sinskey AJ, Berndt ER. Trends in the globalization of clinical trials. Nature Reviews Drug Discovery. 2008 Jan;7(1):13-4

15 All of the issues around trials in developing countries are well covered in two books, Shah S. BODY HUNTERS,THE: Testing New Drugs on the World's Poorest Patients. SCIE. THE NEW PRESS; 2007. And Petryna A. When Experiments Travel: Clinical Trials and the Global Search for Human Subjects. 1st ed. Princeton University Press; 2009

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