So, what are some of the intriguing ethical questions of Kolata’s August 2d article? Here is one: when researchers conduct studies and ethics committees review protocols, resource allocation is an important consideration. If, as Kolata alleges, mediocre trials siphon eligible patients away from good trials, then there is a case to be made that IRBs and investigators need to ponder carefully the effects proposed trials will have on other studies- even when proposed trials have a favorable direct benefit-risk balance for volunteers who enter them.
Second, if resource allocation is a key consideration in realms where patients are scarce, investigators (and IRBs) need reliable criteria for assessing the broader social value of study protocols. They further need some way of being able to compare one protocol against a body of others that are either underway or in the pipeline. The current system provides no straightforward way of doing this.
Third, if 50% of trials fail to recruit sufficient numbers to produce meaningful results, investigators, IRBs, DSMBs, and granting agencies are doing a lousy job ensuring high ethical standards in human research. It is well established that, for any study to redeem the burdens that volunteers endure on enrollment, it must produce valuable findings. It is disturbing, to say the least, that many volunteers enter studies that go nowhere, and that investigators, IRBs, and funding agencies are not realistically projecting recruitment.
Last, Kolata suggests that many cancer trials are merely aimed at “polishing a doctor’s résumé.” It would make a useful contribution to the field of cancer research- and bioethics- to measure the frequency of this practice. Meantime, this inability of IRBs to detect this kind of conduct, and stop it in its tracks, signals an important deficiency in human protections. Which leads me to my next post… (photo credit: ziggy fresh 2006)
@Manual{stream2009-88,
title = {Help Wanted, Part 2},
journal = {STREAM research},
author = {Jonathan Kimmelman},
address = {Montreal, Canada},
date = 2009,
month = aug,
day = 9,
url = {http://www.translationalethics.com/2009/08/09/help-wanted-part-2/}
}
MLA
Jonathan Kimmelman. "Help Wanted, Part 2" Web blog post. STREAM research. 09 Aug 2009. Web. 19 Apr 2024. <http://www.translationalethics.com/2009/08/09/help-wanted-part-2/>
APA
Jonathan Kimmelman. (2009, Aug 09). Help Wanted, Part 2 [Web log post]. Retrieved from http://www.translationalethics.com/2009/08/09/help-wanted-part-2/
Earlier this week (Aug 2), Gina Kolata of the NYTimes ran a fascinating story about challenges recruiting patients to cancer clinical trials. The story contains interesting facts, credible claims, analysis, and unfortunately, some misleading conjectures. The problem of patient recruitment also invites some hard headed ethical analysis.
First the facts. According to the article, one in five National Cancer Institute-funded trials fails to enroll a single subject; half fail to recruit enough to produce meaningful results. Now some credible claims: many trials are “aimed at polishing a doctor’s résumé, and produce meaningless results; many oncologists avoid cancer studies because they can be a money loser, and many patients shy away from trial participation- particularly when their cancer is less advanced and they can obtain treatment outside of trials.
The article, however, is swathed in some misleading conjectures. The article makes the suggestion that problems with recruitment are “one reason” and “the biggest barrier” to major strides in the “war on cancer” (hence the recruitment poster in the graphic above). Hard to reconcile this with Kolata’s contention elsewhere that many trials are useless. It’s also hard to square the claim with Kolata’s point, earlier in the article, that trials involving really promising drugs usually have no problems with recruitment. In one famous case, a Phase 1 trial testing endostatin at Harvard received 1000 inquires from patients for 3 slots in the trial (Pop quiz: see if you can guess which New York Times reporter wrote an article on endostatin that many commentators criticized for sensationalizing the drug’s promise?). Third, with only about 1 in 20 cancer drug candidates making it from phase 1 tests to FDA approval, a reasonable question to ask is whether preclinical researchers are validating their drug candidates properly. And finally, the article makes no mention of the fact that many studies have exceedingly narrow eligibility criteria. Many patients may be solicited for trial participation- but only a fraction meet eligibility criteria.
Still, Kolata’s article is enlightening and raises a number of intriguing questions that demand ethical analysis. I’ll discuss some of these in my next posting (photo credits: Joan Thewlis, 1918 Recruitment Poster, 2009).
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title = {Help Wanted- For the War on Cancer},
journal = {STREAM research},
author = {Jonathan Kimmelman},
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month = aug,
day = 6,
url = {http://www.translationalethics.com/2009/08/06/help-wanted-for-the-war-on-cancer/}
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MLA
Jonathan Kimmelman. "Help Wanted- For the War on Cancer" Web blog post. STREAM research. 06 Aug 2009. Web. 19 Apr 2024. <http://www.translationalethics.com/2009/08/06/help-wanted-for-the-war-on-cancer/>
APA
Jonathan Kimmelman. (2009, Aug 06). Help Wanted- For the War on Cancer [Web log post]. Retrieved from http://www.translationalethics.com/2009/08/06/help-wanted-for-the-war-on-cancer/
So, what are some of the intriguing ethical questions of Kolata’s August 2d article? Here is one: when researchers conduct studies and ethics committees review protocols, resource allocation is an important consideration. If, as Kolata alleges, mediocre trials siphon eligible patients away from good trials, then there is a case to be made that IRBs and investigators need to ponder carefully the effects proposed trials will have on other studies- even when proposed trials have a favorable direct benefit-risk balance for volunteers who enter them.
