I decided to write this article because I feel the need of
sharing what I’ve learned so far about clinical trials so that other patients
who are in the position of taking part in a trial may know a bit more and may
take better informed decisions.
I hope this article reaches those people who feel they are
standing on the edge of a cliff making a life altering decision, having the
sentiment of no one being on their side.
First things you should know about medical trials is that
“it’s not about you”. The quicker you understand this, the easier it will be to
adjust your expectations regarding the trial. We are used to create bonds with
our doctors because we know their first priority is to treat us, their patients.
In clinical trials the goal is to obtain new medical data, preferably the kind
of data that can be generalized. Read this and understand it well. Don’t get into
a medical trial having the wrong expectations. You already have enough on your
plate as it is.
As a patient, you need to be informed about what will happen
during the trial. You need to take an informed decision so ASK anything you are
unsure of, anything you feel you might want to know. Before you start a medical
trial you will need to give your Informed Consent. This is a document that
should answer most of your questions and should be written in terms you can
easily understand. My advice, take a piece of paper and write down all the
questions that rise from that document so you can discuss them to your doctor the next time you meet.
Know that just because you gave your consent it doesn’t mean you are no longer
allowed to ask questions or the doctor is not obliged to answer them. You can
and should ask any question you consider relevant at any point in the trial.
Some questions will rise during the trial so there would be no way for you to
foresee them.
Trials are free. If a doctor asks you for money in order to join a trial,
something is fishy either with the doctor or with the trial. You can verify the
existence of the trial here: https://clinicaltrials.gov.
If it’s not here it doesn’t exist.
If a doctor asks you to sign a paper assuming responsibility for whatever
happens within the trial, know that, apart from the fact that it’s unethical,
it’s also very much illegal so the paper is void. Even though you give your
informed consent the researchers are still the ones who are responsible for
your well being. There is also an ethical board you can denounce the doctor to.
There are some principles that every trial should abide. To know them means to
know your rights and to be able to defend them.
Beneficence or non Maleficence – what it means is that a
doctor should do well or, at least, do no harm. Translated into trial reality
this means for example that if a treatment exists for a disease, the researchers
are not allowed to give placebos in a trial for a new drug. They are bound by
ethic rules to give patients from the control group the treatment that already
exists.
Autonomy – This means that the free choice of the patient to
participate or not in a trial needs to be respected no matter what. For the
patient this means that he/she needs to be very well informed in order to: 1. not lose the opportunity of participating in a
trial that may change his/her life or 2. on the contrary, to participate for the
wrong reasons/expectations. There is a
special chapter in this section dealing with coercion. The decision, which ever
it would be, needs to be based only on arguments and information. Offers or
insinuations of offers regarding money, better life conditions during the
trial, psychological pressure or any kind of pressure for that matter should
not exist.
Distributive justice – In clinical trials it refers to the fact that the
constraints as well as the potential benefits that rise from the research
should be fairly distributed among the participants in the trial.
For further reading click here
Ok, so you can ask ANYTHING but there are so many things you
don’t know that you don’t even know where to start. Here is a list of questions
you might want to start with.
- What is being
studied?
- Why do researchers believe the
intervention being tested might be effective? Why might it not be effective?
Has it been tested before?
- What are the possible interventions
that I might receive during the trial?
- How will it be determined which
interventions I receive (for example, by chance)?
- Who will know which intervention I
receive during the trial? Will I know? Will members of the research team know?
How do the possible risks, side
effects, and benefits of this trial compare with those of my current treatment?
- What will I have to do?
Other information that the investigators may inform the
participants about include:
- the trial’s place in the scientific study (Phase I, II, III)
- the endpoints of the study
- the anticipated benefits
- the scheme of the study (controlled/not controlled, blinding/not
blinding/double blinding)
- potential risks.
One other thing that it’s important to know: When you ask a
question be ready for the answer. Probably some answers won’t be pretty, like
the ones related to potential side effects and risks. Make sure that you
understand and weight them well in your decision. Researchers will not put you
in harm’s way just for the fun of it. Human research is done only when there is
no alternative. But risks do exist end you need to make sure you have assumed
them when you are moving forward with a trial.
One last thing…The trial will be uncharted territory for you
so don’t take anything for granted. Be sharp, be vigilant because in the end you
are the only one representing your own interest in a medical trial.
