What does someone who is asked to participate in a clinical trial need to know before signing on?
This is not a decision to be taken lightly, but only after a period of reflection. The person needs to take his time and also take the time to consult someone else in order to better understand all of the issues.
He should receive a copy of all the documents, including the consent form, before signing and have the opportunity to consult someone with the documents in hand.
He should understand the experimental nature of a clinical trial: this is not like a regular prescription.
If it is a new medication, it is important to understand what phase the trial is (I to IV): the smaller the phase, the greater the uncertainty concerning the effects.
It is also important to understand the objective of the trial. More and more, companies are conducting non-inferiority rather than superiority studies. For me, this is like a study to establish that a medication is quot;not bad" in relation to another, which is much less interesting.
In a practical manner, what are the steps a person should follow to obtain the information he needs?
I would underline the importance of getting advice from someone who is not a part of the research team and who is not the treating physician. Yes, these people have a lot of information that is both interesting and necessary, but they also have a conflict of perspective of which they are not always aware in relation to participation in the study. To truly reflect on the pros and cons of participating, the point of view of an external person is very useful.
In your opinion, what are some common practices that compromise the rights of people participating in clinical trials today?
I wonder about the usefulness of the system of protection of the rights of humans participating in research. It seems like the research ethics boards spend a lot of time revising long consent forms, while it is often the verbal interaction with the research team that has the greatest impact on the participants' understanding of the research. The consent forms serve to protect the researchers and the members of the research ethics board become a resource for the researchers and not for the participants. How can we explain that the person who has the role of protecting the rights of trial participants has no contact with them, only with the researchers?
The other element I would stress is that of the 'trade secret' aspect around clinical trials. Yes, there are commercial interests involved in the development of new drugs, but this is too often translated by the impossibility of obtaining a copy of the consent form before it is signed. How can one consult an external expert on the content of the form without having a copy in hand?
Do you have any particular advice for someone who is newly diagnosed who is invited to participate in a clinical trial?
These individuals are among the most vulnerable because of their emotional state and their level of understanding of the issues around all clinical trials. There are so many things to understand and the shock of an HIV diagnosis can be so difficult that it is not clear that a person in this position would be able to give his free and informed consent. In these cases, it becomes even more important to have access to an external person to truly understand what is being asked and what is involved from an objective position.
What do you think of trials on the use of treatment as prevention?
These trials raise some important ethical issues that are often different from therapeutic trials.
Take the issue of the "placebo" arm of a study. In a therapeutic trial, the placebo effect is often positive — the person believes that the treatment received will improve his health and even the people in the placebo arm who are not receiving the study drug benefit from the effect of positive thinking. In a preventive trial, what is the placebo effect? Essentially, the effect can be negative and present a danger to the person if he has a false sense of protection which drives him to take more risks. Is it necessary in these cases to have a placebo arm?
In British Columbia, there is a trial on using treatment as a method of protecting the partners of seropositive people. How would you react to this phenomenon?
I do not agree with this public health approach to treat everyone in order to reduce HIV transmission. They are not taking into consideration the long term effects of medications that we will not understand before having many years of experience of them.
Is there an ethical problem with financial compensation of clinical trial participants?
It is reasonable for participants in a clinical trial to receive monetary compensation for their time and inconvenience. However, I find that there is inflation in this compensation, particularly in HIV, that risks becoming an incentive to participation. When the amount is too large, or when money becomes an element in the decision of whether or not to participate, the sense of free and informed consent is lost.
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Jean-Pierre Bélisle has been an activist in the fight against HIV since 1993 and is a past board member of CTAC. He has a particular interest and expertise in research and research ethics.