Each clinical trial has benefits and risks. Therefore, it is understandable if you are worried about joining a clinical trial. Having all the facts and answers is important to make an informed decision about participating in a clinical trial.
It is important that you discuss participation with your doctor. Your doctor needs to help you understand both the risks and benefits of the investigational treatment or vaccine you will be given and decide what’s best for you.
The investigational treatment may not be as effective as available treatment options or may have unexpected, unpleasant or even life-threatening side effects.
Patients may not receive a treatment under investigation due to random assignment of the placebo.
Patients may be required to commit more time than usual for doctor visits or travelling to sites.
Patients may spend more money than usual traveling to visits or on special medicines that are not covered by insurance companies.
Patients have better access to new treatment options before they are widely available.
Patients help society and other people living with the disease or condition by making a valuable contribution to medical research.
Patients receive high quality medical care as they have better access to medical specialists and their health is closely monitored.
Patients have a better experience with medical care as they play an active role in their own healthcare.
Remember that taking part in clinical trial is a personal choice. If you do decide to join a clinical trial, it’s always voluntary. This means, you can leave at any time if you change your mind.
AstraZeneca clinical trials are carefully designed with the highest ethical and safety standards.
We run our trials in accordance with the principles of Declaration of Helsinki and Good Clinical Practice (GCP).
AstraZeneca is using several principles to ensure participants feel safe whilst taking part in our clinical trials.
Informed Consent process is the process of learning and discussing the details of the clinical trial with the study doctor before deciding whether to take part. This is also time for the potential participants to make sure all their questions have been answered. All details about the clinical trial are outlined in a document called the Informed Consent Form (ICF). The ICF focuses on the purpose of the clinical trial, its duration, required procedures, potential benefits and risks and what will happen to data collected from participants.
Informed Consent process is the process of learning and discussing the details of the clinical trial with the study doctor before deciding whether to take part. This is also time for the potential participants to make sure all their questions have been answered. All details about the clinical trial are outlined in a document called the Informed Consent Form (ICF). The ICF focuses on the purpose of the clinical trial, its duration, required procedures, potential benefits and risks and what will happen to data collected from participants.
The aim of clinical trials is to bring potential new treatments or vaccines to people living with a specific disease or condition to help improve the quality of their lives. Therefore, the success of the clinical trial relies on healthy volunteers or patients willing to take part in a clinical trial.
While patient recruitment is important to start a clinical trial, retention of patients is critical to ensure the clinical trial is kept on track and moves through all needed phases until completion.
Developing a new treatment takes years, which means that patients may be in a clinical trial for a long time. Excluding medical reasons, patients may sometimes stop attending appointments or stop taking the medication. This is because sometimes they feel discouraged or lose their patience with clinical trial procedures.
As patients have a right to leave a clinical trial at any time, it is important to understand how such decisions may impact successful completion of a clinical trial.
If high numbers of patients resign from a clinical trial, it may be put on hold. This may extend the overall duration of the trial or the trial could be cancelled.
Poor retention of patients in a clinical trial also means a low quality of overall clinical trial data, lower statistical power and decreased confidence in the results.
When a patient leaves a clinical trial, researchers may not be able to use that patient’s data for the overall clinical trial analysis. This in turn puts the approval from regulatory agencies at risk and delays bringing the treatment or vaccine to market for other people living with the same disease or condition.
Therefore, if you decide to leave a clinical trial, please let your study doctor know. This will allow your study doctor to discuss next steps with you.
