Clinical Trial Data Can Trouble Former Participants

In many cases, full disclosure brings serious emotional distress, expert says

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By E.J. Mundell
HealthDay Reporter

MONDAY, Feb. 27, 2006 (HealthDay News) -- For years, the conventional wisdom among those in the research community has been that patients involved in any clinical trial must be told of all the findings once the study ends and the data becomes available.

In this "information age," who could argue with that?

Well, one cancer researcher and physician does argue that a little knowledge can sometimes be a very dangerous thing -- offering no benefit to the patient's current or future care but bringing that person lots of grief and fear.

"Sometimes this is information that's particularly difficult within the cancer setting, where patients are dealing with all kinds of things, including how well they're doing now and what their future is," explained Dr. Maurie Markman, vice president for clinical research at the University of Texas M.D. Anderson Cancer Center, in Houston.

"What does it mean to tell patients that 45 percent of the patients died within three years?" he said. "What does it mean to tell them that they were on the 'wrong' arm of the study, even though they may now be doing fine? Does it mean that they are now going to die? And how long are they going to have to worry about this?"

In these cases, "full disclosure" becomes a Pandora's box of worry that can't be shut, Markman explained in a special commentary published in the April 1 issue of Cancer.

He believes that current trial protocols mandating the automatic disclosure to ex-participants of all results are misguided and detached from serious, real-life conversations that take place in doctors' offices or at the bedside.

"To say, 'We are just going to give them the information and try and explain it' -- that statement shows a truly profound lack of understanding of the complexities of the human psyche," Markman said.

Instead, the Texas expert believes patients enrolling in clinical trials need to be informed before they join the study that data obtained from the trial may end up being of little or no clinical relevance to their own illness -- and might cause them emotional harm. According to Markman, many might then opt out of receiving data that isn't pertinent to their ongoing care.

If there's a piece of information that could affect patients -- for example, the superiority of a drug still deemed appropriate for their type and stage of disease -- "then absolutely, you must inform the patient," Markman stressed.

But he noted that, especially in the case of cancer patients, individuals who received a poorer-performing drug during a clinical trial -- those on the proverbial "wrong arm" of the study -- may no longer be eligible to receive the superior medication once the trial data is finally published years later.

That's because their cancer has often progressed past the point where the drug is deemed to be useful, or the medication might simply be too toxic for a patient's weakened state. "We've got lots of examples of that -- in adjuvant therapy for lung cancer, for example, we don't get very good effects at all for advanced disease," Markman said.

"So, in other words, the patient's 'window of opportunity' to take the drug has passed," Markman said.

Therefore, to inform this ex-research subject that he "missed out" three years previously on a better treatment seems almost cruel.

This gets to the heart of Markman's argument: That potential research subjects need to know beforehand that much data gleaned from the trial will be useless to them at best, harmful at worst.

"It's not about saying that patients don't have a right to know," he said. However, offering patients the choice of full disclosure of data at the end of the trial can help them avoid needless pain. "You have to explain that all at the beginning," Markman said.

Dr. Adil Shamoo is co-founder of Citizens For Responsible Care and Research, which advocates for the rights of clinical trials participants. He reiterated that "sharing information with the human subject is a good thing," but also agreed with Markman that the risks of disclosure need to be properly spelled out.

"Informed consent is supposed to do that," Shamoo said. "That should be standard operating procedure. Whether everyone follows this is a different story, of course, but you're supposed to tell them all the alternatives. I'd simply make the information available, and if a patient doesn't want to know, that's their autonomous decision."

For Markman, the key fact to remember is that human research subjects remain patients long after they leave a clinical trial.

"Too often, doctors like me aren't involved in this debate and then we suddenly start seeing legislation saying 'Doctors must do x, y and z,'" he said. "The problem is that no one has said, 'Hey, what's the impact on the patient of all of this?'"

More information

For more on clinical trials, head to the U.S. National Institutes of Health.

SOURCES: Maurie Markman, M.D., vice president, clinical research, University of Texas M.D. Anderson Cancer Center, Houston; Adil Shamoo, Ph.D., professor, biochemistry and bioethics, University of Maryland, Baltimore, and co-founder, Citizens For Responsible Care and Research (CIRCARE); April 1, 2006, Cancer

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