Clinical trials provide information about new or existing treatments and their effects on our health. This information can assist in the development of safer and more effective treatments.
All the techniques and medications used today are available thanks to participants in clinical trials. Without volunteers, there would be fewer effective treatments available and we would have less knowledge of those treatments and their effects on health.There are still diseases which either cannot be treated effectively, or at all. Perhaps you can help find ways to better treat these conditions by becoming a volunteer!
Can I participate?
Trial subjects can be divided into two groups:
1. Healthy volunteers:
Healthy volunteers generally have not been diagnosed with a specific disease and are not using any medication. Sometimes certain diseases and medications are permitted (such as hay fever or contraceptive pills), depending on the study protocol.
You are considered a patient if you have been diagnosed with a specific disease and/or are using medication. People with risk factors (such as high cholesterol levels) may also be considered patients.
Healthy volunteers can participate in phase I trials and patients can participate in phase II, III and IV trials.
Research on new treatments is always performed in four phases:
Phase I: Research with healthy volunteers
Phase II: Research with patients (small group)
Phase III: Treatment of patients (large group)
Phase IV: Research with medication already on the market
You can participate in a Phase I trial if you are:
- in good physical and mental health
- not using medication, or can easily stop using it without experiencing problems
- not addicted to alcohol or drugs and never have been before
- not allergic to any medicines
Phase I trials are sometimes performed with patients instead of healthy volunteers, for example if the study involves a new cancer medicine or a medicine that is expected to have more side effects. An example would be new chemotherapy for lung cancer. In these cases the phase I and II trials can be combined.
Apart from the above criteria, there usually are also trial specific requirements, relating to aspects such as:
- height to weight ratio
- smoking habits
You can participate in a phase II, III or IV trial, if you have a specific disease or risk factor, which the new therapy is designed to treat. Normally, you are permitted to use other medications during these trials. The other criteria listed above for the phase I trials also apply to the phase II, III and IV trials.
What are the benefits?
Participation in a trial may offer some benefits. Clinical trials are carefully designed, performed with great attention to detail by experts and are a good way to:
- actively care for your own health
- obtain access to new treatments before they are widely available
- receive the best medical care from the most prominent medical organisations during the trial
- help others, by participating in medical research
- healthy volunteers sometimes receive a fee.