Should I Enter a Clinical Trial–Part Four

What to Consider Before Deciding

Intervention is frequently based on the medical and public perception and assumption that doing something is better than doing nothing. That is not always the case. There are times when the net benefits of all interventions are negative — that is, anything you do will make you worse off.  Rather than starting with the underlying philosophy, “You/We should be able to do something that will fix it” begin by asking what are the likely benefits and costs of each of the alternatives. Then chose the one where the net benefits — the benefits minus the costs — are likely to be the greatest. Take no action when that provides the best results.

When the patient/consumer is not paying for the service, he/she is placed in the position of not having to consider what they are giving up when having the procedure. When that happens they are more likely to elect to have more services than they would if they had to pay for them. Historically, that goes under the name “Moral hazard”. Moreover, the prescribing practitioner and the PhysicianFirm almost always benefit from the additional revenue they receive from providing those services. Often it is someone else, like an insurance company or the government, who ends up paying the bill.

The preconditions

Here are some things to consider before you say, “Yes” to enrolling in a clinical trial. Firstly, make sure you qualify.

• Be realistic about your personal goals.
• Be clear about how your participation will further these goals.
• Make sure you understand what the objective of the trial is and how the study is structured and to be conducted.
• Determine the nature of your involvement and what will be required of you before deciding whether it is worthwhile from your perspective for you to participate.
• Make sure you understand the likely unfavorable outcomes, including the nature and extent of any other costs.
• Be realistic about what your participation involves and what it can provide you.
• Then think twice before saying yes.

Most importantly, pay attention to what you will be giving up if you decide to enter a clinical trial. One evening in the summer of 2002, before Foley entered the trial, while he was on watchful waiting, Bennett asked Foley, “What would you regret dying without having seen?” His one word answer was “Pompeii.” In the fall they took the kids out of school, flew off to Italy and, as a family, did just that. How about that! [Bennett, p. 115] Imagine what it would be like if by signing up for a clinical trial you gave up something like that? And how nice it would be to be able to say your final “Goodbyes” in relative peace.

In summary

It would not be necessary to have a clinical trial if the outcomes were known. They are based on someone’s hypothesis. The chances for a favorable outcome resulting from participation in a clinical trial are minimal. If Dr. Hal Barron, chief medical officer and head of global development at Roche and Genentech, one of the largest international pharmaceutical companies is correct, about ninety five percent of the drugs that enter a clinical trial never get final approval.  Moreover, you cannot be assured that you are getting the drug that is being tested and, even if you do, the unfavorable outcomes and other costs involved — including the additional debility, pain and suffering and the time lost doing what you would prefer to do — may well outweigh any benefit. Frequently, they force the participant to withdraw. Taking account of the likely costs in addition to a realistic assessment of the hoped for benefits before signing up for a clinical trial is a good idea. Since the stakeholders have a strong incentive to get you to participate, make sure that it is in your interest as well as theirs.