I am a Clinical Trial participant
The following section was created using several sources of information considered as reliable and transferable for CDG. The goal is to help you understand clinical trials from a participant’s side of view.
What to expect once you’ve joined a Clinical Trial?
Once you’ve joined a clinical trial, it’s crucial that you adhere to the protocol, pay attention to your symptoms and potential side effects, attend study visits, and share your feedback. At this point, it's essential that you are aware of terms like Principal investigators (PIs) and co-principal investigators (co-PIs), Clinical research assistants (CRAs), Clinical research coordinators (CRCs), etc.
What happens during a clinical trial?
As well as carrying out tests to find out how well a treatment is working, researchers will also look out for any side effects and you may be asked questions about any new symptoms you have. Researchers will also look at the wider effects of treatment on your life as a whole, not just its effects on symptoms. There are also detailed tests and questionnaires that are used to measure people’s quality of life. Some clinical trials will also look at the cost-effectiveness of treatments and their effects on other aspects of care, so you may also be asked about how the treatment affects other areas of your life such as: whether you are able to work during the treatment, the number of times you visit your doctor and nurse, travel, etc. Read more here.
What happens at the end of a Clinical Trial?
After a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about further testing. After a phase I or II trial, the researchers decide whether to move on to the next phase or to stop testing the investigational drug or device because it was unsafe or ineffective. When a phase III trial is completed, the researchers examine the data and decide whether the results have medical importance.
Results from clinical trials are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. If the results are particularly important, they may be featured in news media and discussed at scientific meetings and by patient advocacy groups before they are published. Once a new approach has been proven safe and effective in a clinical trial, it may become the standard of medical practice. Continue reading here.
Additional resources for information related to understanding clinical trials for patients and their families can be found at:
- Podcast Understanding Clinical Trials: What You Need To Know
- A comic to help children and teenagers navigating the Clinical trials journey created by Jumo Health is available here
- What is health research?
- What is a Clinical Trial?
- What kind of trials are there?
- Why do we have Clinical Trials? Why are Clinical Trials so important?
- How do Clinical Trials work?
- How are Clinical Trials structured?
- Who can take part in Clinical Trials?
- What are the benefits and risks of trials?
- How do you find, match and screen for a trial?
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Joana Grilo Sci and Volunteer Program Nova School of Science and Technology 2021.
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