It has been a quiet week on the cancer news front, which gives me an opportunity to discuss a question that has been on my mind since I first read an opinion piece in our journal Cancer recently.
The question is simple: Do patients and their families have the right to know the outcomes of clinical trials in which they participate?
According to a highly regarded cancer researcher, the answer is not so simple, and is essentially “no.”
I don’t agree.
Actually, to be honest, it is a position that has never crossed my mind. My assumption has always been that, for most clinical trials, if you agree to participate you should know the results. Short, simple and to the point.
There are different types of clinical trials underway in cancer treatment. Some are prevention trials with fairly safe, well known drugs (although the recent Vioxx situation has many folks wondering how safe is safe). Other trials are treatment trials, perhaps where two known accepted treatment regimens are compared to each other. Other trials may compare a new drug or treatment program to an accepted, standard therapy. The most difficult trials may be those where a drug is used for the first time on human subjects.
No matter the type of trial, I would assume that the patient and their families might want to have the opportunity to learn the results of the trial. After all, they put their bodies at risk, so to speak, so why shouldn’t they find out if there was a benefit?
That may be time consuming for the investigators and their staffs, and it may be difficult to explain some of the intricacies of trial results in simple terms that most lay people can understand. But at least, to me, it would seem to be the right thing to do.
The author of the article does not agree. He writes, “It is reasonable to conclude that researchers currently do not consider this activity a required component of their obligations to participants in clinical trials. Rather, the major focus of investigators is on insuring the autonomy, and protecting the safety, of research participants both immediately preceding and during the trial and not on an ethical obligation to subsequently inform individuals about what researchers have learned that may be of benefit to future patients.”
In other words, if you read it in the newspaper or see the news on television you got your answer. And, if it doesn’t make the news, that’s the way it is.
The basis of this position appears to be that knowing the results doesn’t really make a difference to the individual, since the treatment has already been provided. Only if knowledge of the results could influence the care of the patient should they be advised of those results (for example, the women on tamoxifen as part of the recent STAR trial should be told that raloxifene had fewer side effects, and should be informed so they can consider whether or not they want to discontinue tamoxifen as a prevention strategy for breast cancer for post-menopausal women at high risk).
Another argument put forth in the paper is that patients and families could not understand the nuances of interpreting the design and results of the trial.
Here, I would compare this statement to the efforts made by many excellent health media journalists who do their best to grasp the key points of a study and provide information to their reading, viewing or listening public.
If they can do it, why can’t the investigators?
Sometimes intelligent folks such as doctors and cancer researchers think in details that most of the public are simply not interested in. They get buried in weeds about their work that don’t transmit well to public audiences.
If they can boil things down for 10 minute or one hour news conferences, my bet is they could boil down the results of their studies for the patients who committed themselves to advancing the particular research endeavor.
Another comment in the paper had to do with the risk of causing harm to the patient.
For example, the patient received treatment B, and the study showed that treatment A was better. But the patient is alive and well. Can the patient deal with the fact they received B instead of A, although for that individual B worked fine? Or what would happen if the patient didn’t do well? Would they or their family have severe misgivings that the patient hadn’t had the “successful” treatment?
If we knew the answer to the question before the study started there would be no reason to do the study, not to mention the fact it would be ethically unjustifiable.
We do clinical trials to answer questions to which we do not know the answers. That is something that the researchers have to explain to their patients when they go through the informed consent process.
Furthermore, studies are supposed to be monitored very carefully so that if it becomes evident that one treatment is clearly superior to the other, the study can be halted and all of the participants can get the benefit of the superior treatment.
We cannot forget that not every trial shows an improvement with a new treatment over an old one. Sometimes, the new treatment is not superior, and sometimes it is actually demonstrably worse than the existing standard treatment.
The author does offer a compromise solution that addresses the questions raised in the article.
He writes, “One solution may be to consider adding a section to each IRB (institutional review board) approved consent form that specifically discusses the possible reasons why a patient may elect to receive or not receive the results of a research study in which they have participated. A major advantage of presenting this discussion at the time of trial entry would the conflicting ethical arguments can be highlighted in general terms, without any knowledge of the actual study outcome.”
That is a reasonable suggestion, and at least puts the question on the table so there are no misunderstandings at a later date. It also empowers the patients and their families to make a selection and offer guidance on how much information they would like. Some folks aren’t interested or don’t want to know; others want to know everything. At least this approach provides an option and an opportunity.
We do not do a good job in this country of getting folks into clinical trials. Clinical trials are the primary and necessary mechanism available to us which helps us advance the science of cancer treatment.
We need to have a better understanding of what would improve participation in clinical trials, beyond the issues of costs and whether they are covered by insurance, or how far the patient lives from a clinical trial location.
We need to understand what motivates patients and families to participate in trials, and we need to know how much they view this participation as good for themselves and good for society. We need to know what they want to know.
And if they want to know the results of the trial, or if their families eventually want to know, it is my opinion that we should make every effort to comply with that request.
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