The benefits and risk of participating in a trial vary depending on the type and purpose of a trial. Possible advantages and disadvantages of trial participation are outlined below:
Clinical trials are done with the sole aim of testing medicines, medical devices and treatments that will ultimately be made available for human health. By participating in trials:
- You may gain access during and after the clinical trial to new treatments that are not yet available to the general population
- You may obtain medical care free of charge
- You will be closely monitored for possible adverse events
- You are contributing to medical research that may result in the advancement of medicine and healthcare in general thereby helping other fellow human beings
- Participating in clinical trials is not a source of primary or additional income. However almost all sponsors reimburse persons that participate in trials for all reasonable expenses related to participating in the trial, including travel expenses, food, medical care and compensation for provable and insured adverse events that are related to the trial.
There may be serious adverse events (SAEs) that are related to the medications used or procedures that are done in the trial; however study participants are intensively monitored so that SAEs may be detected early and managed appropriately. There is also insurance cover for some SAEs, so that participants may be compensated accordingly.
The medicines, vaccines, medical devices or treatment options used in the trial may not be effective for your disease; there are, however, safety procedures in place so that those participants who do not benefit from the trial medical management options may be switched to alternative effective treatment immediately or at the end of the trial.
The trial guidelines may require some adjustment of one or more aspects of your life, such as:
- You may need to set aside time for trial related activities like visiting the trial site
- You may not use certain medications including traditional medications without the approval of your trial doctor
- Your personal private or social life may be affected, e.g. sexual activity, reproductive functioning, consumption of alcohol, tobacco or other drugs of abuse, etc.
- You may have to consult your usual healthcare provider for all your other illnesses that are not related to the trial, but still you have to inform your provider that you are part of a trial and that certain medications or treatment options may not be compatible with your trial protocol
- Your employer, medical aid, personal insurance and/or Commissioner for Compensation for Occupational Injuries may not pay for claims that are related to events due to your participation in clinical trials; it is therefore extremely important that you verify that the sponsor of the trial has an appropriate comprehensive insurance cover for you.
You should ensure that you discuss your participation in a clinical trial with your health care provider (ie doctor), your family and all those who may be affected before joining the trial.