What if you are asked to take part in a clinical trial or clinical investigation? Before you say yes, make sure you get all the information you need to make an informed decision. Knowledge is key to giving your informed consent as a participant or patient in a clinical trial.
What Do Clinical Investigation Experts Say?
Dr Maria Nyåkern is a leading expert in clinical investigations and clinical research in the medical device industry. With her expertise, she provides training for manufacturers to ensure that they get an introduction to clinical investigations for medical devices.
With extensive experience managing clinical investigations with tens of thousands of patients for various medical devices for some of the industry's leading manufacturers, Dr Nyåkern is the right person to ask what to look for before taking part in a clinical trial.
Here are 4 things that Dr Nyåkern suggests that you collect information on before you agree to take part in a clinical trial.
1. Talk To The Research Staff
Before participating in a research study or clinical trial, make sure you have time to speak to the research staff. It is especially important that you talk to the doctor treating you so you can find out about the trial's possible risks, obstacles, and discomforts.
Ask the team to explain clearly what the potential expected benefit(s) are for you as an individual and how they see that they outweigh the risks of participating in a clinical trial.
2. Confirm That The Trial Has Approval And A Good Reputation
The next thing you should look into is to confirm that the research has received approval or favourable opinions from authorities and independent ethics committees.
If this is the case, then it is often mentioned in the informed consent that you will sign before participating in any clinical research activities. Make sure that you really read through this consent form carefully before signing it. If you have any questions, ask them before you sign.
3. Learn About The Qualifications Of Medical Staff
There are always risks with clinical investigations because these medical devices or medical inventions have not yet been thoroughly tested and released to the market.
Because of this, it is important that you ask about the qualifications of medical personnel responsible for the medical care you will receive, and for any medical decision(s) made on your behalf. You should also find out how to contact them if you have any questions or concerns along the way.
4. Get Updates Regarding The Study And Results
As a participant in a clinical trial, you have the right to receive information about any updates or changes along the process. Use this right and make sure you get information about any updates on the study and results.
You can, for example, ask if this information will be published on any public databases and if so, which ones.
Information is key in making informed decisions. Hopefully, these tips from clinical investigations expert Dr. Maria Nyåkern will help you decide which clinical trial is right for you.
