What’s Your Opinion On Joining Clinical Trials?

I have hepatitis C and the doctors at the medical center where I go say it’s time for me to be treated, based on a biopsy. They want me to join an experiment they are running to try to find a better treatment, but I think it means I may get a placebo, and I want to be sure to get the best treatment available. What do you advise?

The experiment that today’s writer mentions is probably a clinical trial comparing one treatment for hepatitis C against a newer and unproven treatment. If it is a good trial, it will be randomized, meaning that the people with hepatitis C will be randomly assigned to one or the other treatment regimen, and it will probably be double blind, meaning that neither the individual nor her doctor will know which regimen she is on until the trial is over.

Modern medicine has been advancing at such a great rate during the past 50 years, with so many new medicines being developed all the time, that these types of trials have become crucial to determining what treatments are most effective, and what side effects are produced by the new treatments. Although no one likes to feel that they are being experimented upon, being able to enroll people in these trials is absolutely crucial to our being able to treat diseases more effectively. The recent scandal over the use of bone marrow transplants to treat disseminated breast cancer offers an important and painful lesson on this point.

When bone marrow transplants were first proposed as a means of allowing a woman with advanced breast cancer to survive massive chemotherapy, a few very small trials which were not randomized appeared to support the efficacy of the treatment. Many women with advanced disease understandably wanted to receive the treatment, so much so that it became difficult to enroll women in trials where they might not get the active treatment. Massive chemotherapy and bone marrow transplant involve considerable risk to the woman receiving it, and are painful and sickening under the best of circumstances. Despite these facts, and without being carefully evaluated, bone marrow transplant rapidly became the accepted best treatment, to such an extent that insurance companies, which had always refused to cover it on the grounds that it was experimental, were pressured to include it in their coverage.

In the past year or so, several of the randomized trials that did go forward reported their findings, and most found that bone marrow transplants did not improve survival rates in this terrible disease. The single trial that seemed to show a benefit was subsequently shown to involve falsified results which invalidated it.

I believe that this story demonstrates how important it is to evaluate any new treatment before it is accepted as the best, or even as effective. In our writer’s case, her trial will probably involve a comparison between interferon with ribavirin, the current best treatment, and some new treatment. Since there is an effective, though not perfect treatment for hepatitis C, it would be unethical to have a group in the trial that received an inactive drug or placebo. All institutions doing this type of trial must have it approved by an institutional review committee which closely looks at the ethics of the trial as well as the medical aspects and safety. There will probably also be a committee which sees the results as they come in, and which will have the power to terminate the trial if the new treatment proves to be very much better than the old one, or if it proves to be very much worse, or to have harmful side effects.

It is also becoming common practice in these trials for the people receiving the less effective treatment, as determined by the trial, to be offered the more effective treatment after the trial ends. Our writer should certainly ask her doctors if this is the plan in their trial, since it will guarantee that sooner or later she will receive the most effective treatment available.

So I would urge our writer to seriously consider joining the trial. Not only will the care probably be supported by the sponsors and therefore be much more affordable than the standard treatment for hepatitis C, but she will probably have an opportunity to get the most effective treatment known, either during the trial itself, or when it is finished.

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