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Clinical trials and tribulations
November 2014
by Jeffrey Bouley  |  Email the author
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Several months ago, some folks I follow online were raving about a new anime series available through a steaming video website dedicated to that genre, and I got sucked in. To get quicker, uninterrupted access to the episodes, I paid for a membership. However, since I’m not into anime overall as much as when I was younger, I canceled that membership after a few marathon sessions to plow through the series.
 
I’ve done this kind of thing before. Enjoy the benefits of a free trial offer and cancel before the first payment is due. Pay for access to a site only long enough to get all the materials I need from it. Join a movie/music service to get my first dozen or so DVDs and/or CDs for a penny plus shipping and handling, and then fulfill my membership requirements as quickly and cheaply as possible to ensure that my discs overall still cost me less than going to a store…
 
…wait, that last one probably dated me a bit. Egads, I’m getting old fast (though not quite old enough yet to enjoy AARP benefits and discounts).
 
My point is that many of us like to enjoy these free or reduced-cost benefits, but in the vast majority of cases, eventually we need to pay. Or pay more. Or cancel. And so it is with clinical trials and the push in recent years for pharma and biotech companies to do clinical trials well outside one’s national borders. The lure has been lower costs and often easier patient recruitment. But the bill may coming due, and the value proposition—though it probably won’t be entirely eliminated—will likely drop noticeably.
 
By the way, I’m going to avoid the popular term “overseas trials.” Certainly, Central America is not overseas from Canadian and U.S. pharmas. Asia is not overseas from European pharmas. And India—both a major player in pharma and a popular clinical trial locale for pharmas based elsewhere—certainly isn’t overseas from itself.
 
Ah, India. The real impetus for this month’s editorial.
 
Let me quote from an article in The Hindu, titled “A steel frame for clinical trials,” that caught my eye in October: “In recent months, the quest for a safer, more transparent clinical trials regime has found new momentum. Fourteen notifications in July 2014, governing various aspects pertaining to a clinical trial—ranging from placebo-controlled trials to compensation awards—have been notified. Further, the Central Drugs Standard Control Organization (CDSCO) has proposed a forward-looking IT-enabled information system that will ensure transparency and protect the interests of trial subjects.”
 
And just a month earlier, on Hindu Business Online, this excerpt: “Pharmaceutical companies, research labs and others looking to conduct clinical trials will now have to justify the research. India is seen as a cheap destination for clinical trials and companies often test products meant for overseas markets here. A new order issued [by CDSCO] makes it compulsory for these entities to prove why the research needs to be conducted in India.”
 
Interest in clamping down a bit on trials by outside nations inside India has been brewing for years. That might have been spurred sharply by the news in April that 254 Indian women from modest backgrounds died in the course of a 15-year U.S.-funded clinical trial—a trial for a cervical cancer screening method in which the women who died were part of a control group denied screening, raising ethical concerns among Indians.
 
Ethical concerns and missteps are not uncommon in the world of clinical trials. But they may be put in a more stark light if missteps or corner-cutting take place in parts of the world that offer “budget trial costs.” Without minimizing the need for ethicality, though, let me be blunt: The bill is coming due for those cheaper trial locales. Pharmas and biotechs should probably be thinking now about better ways to streamline costs and increase efficiencies.

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