Did I tell you I learn A LOT in the #efpPPCC event I attended recently? That is why I am here again, hehe: because I have sooooo many things to say! Alike many other patients 🙂 .
This time I would like to draw your attention on some of the matters that worry me when it comes to clinical trials. The bellow slide from Therese Johnsen (Novartis) outlines perfectly what this article is about (thanks for such a refreshing talk in the coffee break, Therese!!!!).
A clinical trial is a serious matter… A whole patients community and their relatives depend not only on the investigators and nurses that develop and work on it… All patients depends in each one of the patients participating in the study.
Do those patients know the importance of what they are doing?
Why are they participating in the clinical trial?
And, most important… How they feel about it?
In this article I would like to know your thoughts about some of the things I am missing in clinical trials:
- Why the patient is enrolling the trial? How does he/she feels about it? Phycological issues.
- Before the trial… Has the patient and the family understood the informed consent? Have they asked the right questions to the physician that is enrolling them in the trial?
- During the trial… Is the patient worried about how the treatment can affect him/her?Does he/she feels scared or worried? Does he/she know in which cases the investigator need to be contacted? Does he/she know how to contact?
Please feel free to leave your comments at the end!
You have notice, right? How the patient and the family feels in each stage of a clinical trial is something that worries me a lot! As T. Thormann very well stated in the #efpPCCT, medicine is only the top of the iceberg…
A whole psychological world lives around the patient and it can affect the effectiveness and even the safety of treatments and hence the result of a clinical trial. For instance, many patients get worn down because the treatment doesn’t seem to be kicking in as quickly as they expected.
I have seen cases in which a patient felt so stressed out during a clinical trial! She was scared and worried to death about the possibility of having some adverse events.
All I could tell her was «if you feel that way just leave the clinical trial». But I don’t know what she did at the end…
I hope you see the point I am trying to make here:
Am I the right patient to undergo a clinical trial?
Because I have come to the conclusion that not every patient is ready for it…
And it’s a serious matter because a stressed out patient, a patient that don’t understand the importance of adherence and the impact of a clinical trial can be a stopper for a new treatment… And that affects a whole community.
One of the questions I asked my doctor before enrolling a clinical trial was «Will I get regular psychological check ups?»
The answer was ‘no’… And I think they are needed!!! Not only to check if the patient is the right one to participate in a clinical trial but also to have a follow up on how the patient is feeling during the trial and manage any issue that can arise and that could affect the results of the trial.
I am not talking about 2 questions about suicidal thoughts and anxiety… I am talking about a proper chat with a psychologist who can tell how I am really feeling.
Before the trial
- Why the patient is enrolling the trial?
- How does he/she feels about it?
- Has the patient and the family understood the informed consent?
- Have they asked the right questions to the physician that is enrolling them in the trial?
- Psychological issues already mentioned.
I think that knowing the reason why a patient is enrolling a clinical trial is a good way to learn how the healthcare system can improve. Many patients do it in order to get «free» treatment while others do it for the sake of science.
I also have a reason to enrol the trial I am participating in, but I will tell you about that another time 😉 .
THIS would be my dream come true!!! In the same way we receive a short training when we start a new job, why not do the same in clinical trials?
Physicians and nurses could explain to us what is a clinical trial about, the stages, what would happen in each one of them… What is placebo!!! And how, who and when we should contact in the trial team (adverse events, specific symptoms, fear, anxiety…)
Patients and their families could fully understand the informed consent and for sure not feel so scared about it (because it’s scary as hell!!!).
They could ask the questions they have and listen to other patients’ questions they didn’t think about- a very good advantage!!!
Most importantly, physicians and nurses could answer the important questions patients don’t know they should ask…
In this way everyone would have the whole picture, the best quality information and answers to alllll the possible questions. Patients and families will be sure if they are enrolling the clinical trial that is right for them and would do it with a invaluable peace of mind 🙂 .
During the trial
As I have just been given my second infusion, I cannot say much about what could be improved during clinical trials… That is, except from the psychological check-ups I am missing.
As I have asked all the questions I am relaxed and calm. I know what to do in case a have a reaction, but I live happy and free of worries because I know everything will be all right.
That is me, right? Because I know what a clinical trial is and I consider myself an informed patient.
After the trial: MY data and the trial results
Why wait for me to ask for the results? Why not ask if I would like to receive them?
One of the core values of patient centricity that Anne Beal showed us in the #efpPCCT was this:
Is this being implemented? How can I, as a patient, help get this? I wanna help!!!!
Many patients like me are so thrilled about the possibility of helping out that I am sure we could have a very positive impact in investigation, clinical trials and other patient’s health.
I have already talked about this is the previous article about the #efpPCCT, so please have a look at it and let me know your thoughts.
Why not use all the tools we have at hand?
Please!!! Starting by «using» these empowered patients I have just talked about. We are not here to replace anyone’s roll. We are patients and we now our role as such.
And what about the wearables, apps and the new technology? That is what I will be talking about in the next article…
To be continued… 😉
– #efpPCCT: Yes to Pacient-Centric Clinical Trials!!!