In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants’ behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.
The purpose of clinical trials is to collect data about the safety and efficacy of new drug and device development. There are several steps and stages of approval in the clinical trials process a drug or device must go through before it can be sold in the consumer market. [Read more…]
Participating in a clinical trial can be a difficult decision to make. Is it right for me? Would I qualify? What if I get worse? Can I quit? These are very real concerns and you should have those answers before deciding. [Read more…]
When you give written consent to participate in a clinical trial, you are acknowledging that you understand and accept all aspects of the research study including any risks or benefits involved. However, informed consent is more than signing a document — it is ongoing conversations between the research staff and you before, during, and after a study. [Read more…]
Sometimes it sounds like doctors and researchers speak a foreign language. “Phase II is a longitudinal, double-blind placebo…” From A to Z find we can help you find out what the Belmont Report is, what double-bind means, or what a pilot study is. [Read more…]