Besides gathering important information about new medications and treatments, one of the main goals for organizations running clinical trials is to minimize the risks to participants.
Clinical trials are regulated by several federal organizations including the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP). In addition an Institutional Review Board (IRB) must also approve clinical trials. An IRB is a group made up of medical and non-medical members of the community.
All of these organizations review how the trial will be conducted, ensure that participants give their consent and protect participants against potential risks.
It is up to individuals to ensure that they are fully aware of what is expected of them and what they can expect throughout the trial. This should be clearly outlined in the consent form. If someone chooses to participate in a clinical trial in hopes that a new medication may help them where traditional medications have not, they should be aware that they are not always guaranteed to receive the new medication.
If they do receive the new treatment during the clinical study, there is a chance that there will be no effect because the medicine simply doesn’t work on their condition. Another possibility is that if a participant does receive the new medication they may experience negative side effects.
While the consent form should outline as clearly as possible what the participant can expect there may be times when the medication or treatment requires more time and commitment than researchers originally thought. Participants should also look at who is conducting the test and try to gauge their intentions.
As an example, if a pharmaceutical company were testing a new drug against one of their competitors, obviously they would prefer their drug to perform better in the clinical trial.