Friday, April 1, 2016

Scratching the Surface on Clinical Trials

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: 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?
See the full list here.
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.

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